OmvoH

Italy
Brand name OmvoH
Form solution for infusion, concentrate
Active substance / Dosage
MIRIKIZUMAB
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
L04AC24
Registration number 050695
Manufacturer ELI LILLY NEDERLAND B.V.
OmvoH solution for infusion, concentrate

Table of Contents

Package leaflet: Information for the patient

Omvoh 300 mg concentrate for solution for infusion

mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh is used to treat the following inflammatory bowel diseases:

  • Ulcerative colitis
  • Crohn’s disease

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and specifically bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with ulcerative colitis and Crohn’s disease.

Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of ulcerative colitis, such as diarrhoea, abdominal pain, urgency, and rectal bleeding.

Crohn’s Disease
Crohn’s disease is a chronic inflammatory disease of the digestive tract. If you have active Crohn’s disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of Crohn’s disease, such as diarrhoea, abdominal pain, fatigue, and urgency.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor before using Omvoh.
  • if you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections.
  • Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle pain, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who might have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are about to receive any vaccination. Some
types of vaccines (live vaccines) must not be administered during treatment with Omvoh.
Allergic reactions

  • Omvoh may potentially cause severe allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a severe allergic reaction: rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of throat tightness, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check whether your liver is functioning normally. If blood test results are abnormal, your doctor
may stop treatment with Omvoh and perform additional liver tests to determine the cause.
Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not been
studied in this age group.
Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently using, have recently used, or might use any other medicines
  • if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) must not be administered while using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh in pregnant women are unknown. If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant and you should use an effective method of contraception while using Omvoh and for
at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.
Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.
Omvoh contains sodium
This medicine contains 60 mg of sodium (a main component of table salt) in each 300 mg dose for the treatment of ulcerative colitis. This corresponds to 3% of the maximum recommended daily dietary intake of sodium for an adult.
This medicine contains 180 mg of sodium (a main component of table salt) in each 900 mg dose for the treatment of Crohn's disease. This corresponds to 9% of the maximum recommended daily dietary intake of sodium for an adult.
Before Omvoh is administered to you, it is mixed with a solution that may contain sodium. Talk to your doctor if you are on a low-salt diet.
Omvoh contains polysorbate
This medicine contains 0.5 mg/mL of polysorbate 80 in each vial, equivalent to 7.5 mg per induction dose for the treatment of ulcerative colitis and equivalent to 22.5 mg per induction dose for the treatment of Crohn's disease. Polysorbates may cause allergic reactions.
Inform your doctor if you have known allergies.

3. How to use Omvoh

Omvoh is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of ulcerative colitis and Crohn’s disease.
How much Omvoh is given and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.
Ulcerative colitis

  • Treatment initiation: the first dose of Omvoh is 300 mg and will be administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another dose of Omvoh 300 mg 4 weeks later, and again 4 weeks after that.

If an adequate therapeutic response is not achieved after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16, and 20.

  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered via subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 200 mg maintenance dose will be given either as two injections, each containing 100 mg of Omvoh, or as one injection containing 200 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion. Your doctor or nurse will inform you when to switch to subcutaneous injections. During maintenance therapy, you and your doctor or nurse must decide whether you should self-inject Omvoh after receiving training on the subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.

Crohn’s disease

  • Treatment initiation: the first dose of Omvoh is 900 mg (3 vials of 300 mg each) and will be administered by your doctor via intravenous infusion (intravenous drip into a vein in the arm) over at least 90 minutes. After the first dose, you will receive another dose of Omvoh 900 mg 4 weeks later, and again 4 weeks after that.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be administered via subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 300 mg maintenance dose will be administered using a pre-filled syringe or pen of 100 mg and a pre-filled syringe or pen of 200 mg. The injections may be given in any order.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should self-inject Omvoh after receiving training on the subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.
If you receive more Omvoh than you should
If you have received more Omvoh than prescribed or the dose was administered earlier than scheduled, inform your doctor.
If you forget to use Omvoh
Talk to your doctor if you forget a dose of Omvoh.
If you stop using Omvoh
Do not stop using Omvoh without first speaking to your doctor. If you stop treatment, your disease symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Skin rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Allergic reaction related to infusion (e.g. itching, hives)
  • Increased blood levels of liver enzymes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
carton after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Keep the vial in the outer packaging to protect it from light.
Do not use this medicine if you notice that the vial is damaged or if the solution is cloudy, clearly brown,
or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

Diluted solution
Infusion should be started as soon as possible after dilution. If not used immediately, the diluted solution prepared with sodium chloride 9 mg/mL (0.9%) solution for injection can be stored in a refrigerator (2 °C–8 °C) for up to 96 hours or at room temperature not exceeding 25 °C for up to 10 hours (total time must not exceed 96 hours) starting from the time of vial puncture.
The diluted infusion solution prepared with 5% glucose must be used within 48 hours, of which no more than 5 hours may be at unrefrigerated temperatures not exceeding 25 °C, starting from the time of vial puncture.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally must not exceed 24 hours at 2–8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Do not dilute the infusion solution with other solutions, nor co-infuse with other electrolytes or
medicines.
Keep the diluted solution away from direct sources of heat or light.
Do not freeze the diluted solution.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. Each vial contains 300 mg of mirikizumab in 15 mL (20 mg/mL).
  • The other components are sodium citrate dihydrate (E 331), anhydrous citric acid (E 330), sodium chloride, polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a clear glass vial. Its colour may vary from colourless to
slightly yellow.
Packs of 1 and 3 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France
Lilly S.A.
Avda. de la Industria Nº 30
28108 Alcobendas, Madrid
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.
-------------------------------------------------------------  ---------------------------------------------------------
Omvoh 300 mg concentrate for solution for infusion
mirikizumab

The following information is intended exclusively for healthcare professionals:

Do not use Omvoh that has been frozen.
Any unused medicinal product or waste material must be disposed of in accordance with
local requirements.
Traceability
In order to improve traceability of biological medicinal products, the name and batch number of the
administered product should be clearly recorded.
Dilution prior to intravenous infusion

  1. Each vial is for single use only.
  2. Prepare the infusion solution using aseptic technique to ensure sterility of the prepared solution.
  3. Inspect the contents of the vial. The concentrate should be clear, colourless to slightly yellow, and free from visible particles. Otherwise, it must be discarded.
  4. Prepare the infusion bag for the treatment of ulcerative colitis or Crohn’s disease as specified below. Note that specific instructions and volumes are specified for each indication.

Ulcerative colitis: one 15 mL vial (300 mg)
Withdraw 15 mL from the mirikizumab vial (300 mg) using a needle of suitable size (an 18–21 gauge needle is recommended) and transfer it into the infusion bag. If administered for the treatment of ulcerative colitis, the concentrate must be diluted only in infusion bags (bag size between 50 and 250 mL) containing either a 9 mg/mL (0.9 %) sodium chloride injection solution or 5 % glucose injection solution. The final concentration after dilution ranges from approximately 1.1 mg/mL to approximately 4.6 mg/mL.
Crohn’s disease: three 15 mL vials; total volume = 45 mL (900 mg)
First, withdraw and discard 45 mL of diluent from the infusion bag.
Then, withdraw 15 mL from each of the three mirikizumab vials (900 mg) using a syringe and needle of suitable size (an 18–21 gauge needle is recommended) and transfer them into the infusion bag. If administered for the treatment of Crohn’s disease, the concentrate must be diluted only in infusion bags (bag sizes between 100 and 250 mL) containing either a 9 mg/mL (0.9 %) sodium chloride injection solution or 5 % glucose injection solution.
The final concentration after dilution ranges from approximately 3.6 mg/mL to approximately 9 mg/mL.

  1. Gently invert the infusion bag to mix. Do not shake the prepared bag.

Administration of the diluted solution

  1. The intravenous administration set (infusion line) must be connected to the prepared intravenous bag and the line must be primed. For ulcerative colitis, the infusion must be administered over at least 30 minutes. For Crohn’s disease, the infusion must be administered over at least 90 minutes.
  2. At the end of the infusion, to ensure complete dose administration, the infusion line must be flushed with either a 9 mg/mL (0.9 %) sodium chloride solution or 5 % glucose injection solution. The flush must be administered at the same rate used for Omvoh administration. The time required to clear Omvoh solution from the infusion line is in addition to the minimum infusion time of 30 minutes (for ulcerative colitis) or 90 minutes (for Crohn’s disease).

Patient information leaflet

Omvoh 100 mg solution for injection in a pre-filled syringe

mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognise and bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with ulcerative colitis.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of ulcerative colitis, such as diarrhoea, abdominal pain, urgency, and rectal bleeding.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • if you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will assess your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle aches, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe you medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are about to receive any vaccination. Some
types of vaccines (live vaccines) must not be administered while using Omvoh.
Allergic reactions

  • Omvoh may potentially cause serious allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a serious allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of throat tightness, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check whether your liver is functioning normally. If blood test results are abnormal, your doctor
may stop treatment with Omvoh and carry out further liver tests to determine the cause.
Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age because it has not been studied
in this age group.
Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently using, have recently used, or might use any other medicines
  • if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) must not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh in pregnant women are unknown. If you are a woman of childbearing potential, it is advisable to avoid
becoming pregnant and you should use an effective method of contraception while using Omvoh and for
at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.
Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.
Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, equivalent to 0.6 mg per
maintenance dose for the treatment of ulcerative colitis. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.

How much Omvoh is administered and for how long

Your doctor will decide how much Omvoh you need and for how long. Omvoh is intended for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.

Ulcerative Colitis

  • Induction of treatment: The initial dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another 300 mg dose of Omvoh 4 weeks later, and again 4 weeks after that. If an adequate therapeutic response is not achieved after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16, and 20.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered as a subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 200 mg maintenance dose will be given as 2 injections, each containing 100 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion.

Your doctor or nurse will inform you when to switch to subcutaneous injections.

During maintenance therapy, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving proper training in subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.

A caregiver who looks after you may also administer the Omvoh injection after receiving adequate instructions.

Use a reminder method, such as marking a calendar or diary, to help you remember the next dose and avoid forgetting or repeating administration of the medicine.

If you receive more Omvoh than you should

If you have received more Omvoh than prescribed or the dose was administered earlier than scheduled, inform your doctor.

If you forget to use Omvoh

If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, resume administration every 4 weeks.

If you stop treatment with Omvoh

Do not stop using Omvoh without first talking to your doctor. If you stop treatment, symptoms of ulcerative colitis may return.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Infusion-related allergic reaction (e.g. itching, hives)
  • Increased levels in the blood of liver enzymes

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C - 8 °C). Do not freeze.
Do not place syringes in the microwave, run hot water over them, or expose them to direct sunlight.
Do not shake the pre-filled syringe.
Keep in the original packaging to protect from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if the pre-filled syringe appears damaged or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. Each pre-filled syringe contains 100 mg of mirikizumab in 1 mL of solution.
  • The other components are histidine, monohydrochloride histidine, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge contained in a disposable syringe. Its
colour may range from colourless to slightly yellow.
Omvoh is available in packs containing 2 pre-filled syringes of 100 mg and in multiple packs
containing 3 cartons, each with 2 pre-filled syringes of 100 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel: +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel: + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg solution for injection in pre-filled syringe

mirikizumab
2 pre-filled syringes: 1 syringe containing 100 mg and 1 syringe containing 100 mg

Two white and blue injection pens with the label Omvoh 100 mg arranged symmetrically with plungers pointing towards the viewer

Read these instructions before injecting yourself with Omvoh. Follow all instructions step by step.

  • Two Omvoh injections are required for a complete dose for the treatment of ulcerative colitis.
  • Inject one pre-filled syringe of Omvoh immediately followed by a second pre-filled syringe of Omvoh.

Also keep in mind:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled syringe. Do not inject yourself or anyone else until you have been shown how to inject Omvoh.
  • Each pre-filled syringe of Omvoh is for single use only. Do not share or reuse the syringe. This could transmit or acquire an infection.
  • Healthcare professionals can help you decide where on your body to inject the dose. You may also read the "Choosing the injection site" section of these instructions to help you choose the best area for you.
  • If you have vision problems, do not use the Omvoh pre-filled syringe without the help of a caregiver.
  • Keep these instructions for use and refer to them as needed.

Before using Omvoh pre-filled syringes, read and carefully follow all instructions step by step.
Parts of the Omvoh pre-filled syringe
Upper Part

Two pre-filled syringes of Omvoh 100 mg with blue grip and white body, showing annotations on various parts of the medical device

Thumb button
Blue plunger rod
Grip
Grey syringe plunger
Syringe barrel containing the medicine
Needle
Needle cap
Lower Part
100 mg + 100 mg = 1 Complete Dose
IMPORTANT:

  • Two injections are required for a complete dose for the treatment of ulcerative colitis.
  • Inject one syringe immediately followed by the second syringe.

Preparing the Omvoh injection
Remove syringes from the refrigerator Take 2 syringes out of the refrigerator.
Leave the needle cap on the syringe until you are ready to inject.
Allow the syringes to reach room temperature for 30 minutes before starting the injection.
Do not heat the syringes in a microwave, run warm water over them, or leave them in direct sunlight.
Do not use the syringes if the medicine has been frozen.
Do not shake the syringes.

Prepare necessary supplies You will need:

  • 2 alcohol wipes
  • 2 cotton balls or gauze pads
  • 1 sharps disposal container (see "Disposal of the Omvoh syringe")

Inspect the syringes and medicine Make sure you have the correct medicine. The liquid inside should be clear. It may be colourless to slightly yellow.
Expiry date

Diagram of a medical device with a red arrow indicating to press the central black section between the two white parts and the blue handle

Do not use the syringe and dispose of it as instructed by healthcare professionals if:

  • it appears damaged
  • the medicine is cloudy, discoloured, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen

Prepare for injection
Wash your hands with soap and water before injecting Omvoh.
Choosing the injection site Healthcare professionals can help you choose the most suitable injection site for you.

Diagram showing two human figures indicating injection sites: abdomen, upper arms, and thighs highlighted in blue

  • You or another person may inject the medicine into the stomach area (abdomen). Do not inject within 5 centimetres of the navel.

  • You or another person may inject the medicine into the front of the thighs. This area should be at least 5 centimetres above the knee and 5 centimetres below the groin.

  • Another person may inject the medicine into the back of the upper arm.

  • Do not inject in the exact same spot each time. For example, if the first injection was in the abdomen, the second injection – to administer a complete dose – could be in a different area of the abdomen.

  • Do not inject in areas where the skin is tender, bruised, red, or hardened.

Clean the injection site with an alcohol wipe. Allow the injection site to dry before injecting the medicine.
Injecting Omvoh

Two hands holding a syringe being pushed to the right with a red arrow indicating the insertion movement into a device

Opening the syringe

  • Leave the needle cap on until you are ready to inject.
  • Remove the needle cap and dispose of it in household waste.
  • Do not re-cap the needle. This may damage the needle or cause accidental injury.
  • Do not touch the needle.
Technical drawing showing two hands holding a medical device angled at 45 degrees to the skin with directional indication

Inserting

  • Gently pinch and hold the skin at the injection site.
  • Insert the needle at a 45-degree angle.
Two hands holding a syringe to inject medication into a body area with a red arrow indicating the direction of injection

Injecting

  • Slowly press the thumb button to push the plunger all the way down until all the medicine is injected.
  • The grey syringe plunger must be fully depressed to the end of the syringe needle.
A hand holding a white syringe with a blue knob, with two black arrows indicating the base and the tip
  • When the injection is complete, the blue plunger rod should be visible through the syringe barrel, as shown.
  • Remove the needle from the skin and gently release the skin.
  • If bleeding occurs at the injection site, apply a cotton ball or gauze pad to the site.
  • Do not rub the injection site.
  • Do not re-cap the pre-filled syringe.

Two injections are required for a complete dose. Inject one syringe immediately followed by the second syringe.
Disposal of the Omvoh syringe

A hand holding a syringe with a blue button above a sharps and hazardous waste disposal container

Disposing of the used syringe

  • Immediately place the used syringe into a sharps disposal container after use. Do not throw the syringe directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • has a tight-fitting, puncture-resistant lid that prevents sharp objects from coming out
    • remains upright and stable during use
    • is leak-proof
    • is properly labelled to warn of hazardous waste inside.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. There may be local laws regarding the disposal of needles and syringes.
  • Do not recycle the used sharps disposal container.
  • For more information on proper disposal of the container, ask your healthcare provider about available options in your area.

Frequently Asked Questions
Q. What if I let my syringe warm up for more than 30 minutes before injection?
A. The syringe can remain at room temperature up to 30°C for up to 2 weeks.
Q. What if I see air bubbles in my syringe?
A. It is normal to have air bubbles in the syringe. They are not dangerous and will not affect the dose.
Q. What if there is a drop of liquid at the tip of the needle when I remove the needle cap?
A. It is normal to see a drop of liquid at the tip of the needle. This is not dangerous and will not affect the dose.
Q. What if I cannot push the plunger?
A. If the plunger is stuck or damaged:

  • Do not continue using the syringe
  • Remove the needle from the skin
  • Do not use the syringe. Speak with your doctor or pharmacist to obtain a new one.

Q. What if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. How can I tell if my injection is complete?
A. When the injection is complete:

  • The blue plunger rod must be visible through the syringe barrel.
  • The grey syringe plunger must be fully depressed to the end of the syringe needle.

Read the entire Omvoh package leaflet included in this package for more information about this medicine.

Patient information leaflet

Omvoh 200 mg solution for injection in pre-filled syringe

mirikizumab
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognise and bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with ulcerative colitis.
Ulcerative Colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of ulcerative colitis, such as diarrhoea, abdominal pain, urgency, and rectal bleeding.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • if you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle aches, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are about to receive any vaccination. Some types of
vaccines (live vaccines) must not be administered during treatment with Omvoh.
Allergic reactions

  • Omvoh may potentially cause serious allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a serious allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue or throat, difficulty breathing, dizziness, feeling of tightness in the throat, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to monitor
whether your liver is functioning normally. If blood test results are abnormal, your doctor may stop
treatment with Omvoh and perform further liver tests to determine the cause.
Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age, as it has not been studied
in this age group.
Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently using, have recently used, or might use any other medicines
  • if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) must not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of Omvoh
in pregnant women are unknown. If you are a woman of childbearing potential, it is advisable to avoid
becoming pregnant and you must use an effective method of contraception while using Omvoh and for at
least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine.
Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.
Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, equivalent to 0.6 mg per maintenance dose for the treatment of ulcerative colitis. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.
Dose and duration of Omvoh treatment
Your doctor will decide how much Omvoh you need and for how long. Omvoh is intended for long-term
treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is
achieving the desired effect.
Ulcerative Colitis

  • Induction treatment: The initial dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another 300 mg dose of Omvoh 4 weeks later, and again 4 weeks after that. If an adequate therapeutic response has not been achieved after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16, and 20.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered as a subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 200 mg maintenance dose will be given as one injection containing 200 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving proper training in subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.
A caregiver may also administer the Omvoh injection to you after receiving appropriate instructions.
Use a reminder method, such as marking a calendar or diary, to help you remember the next dose and avoid missing or repeating administration of the medicine.
If you receive more Omvoh than you should
If you have received more Omvoh than prescribed or the dose was administered earlier than scheduled, inform your doctor immediately.
If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, resume your regular dosing schedule every 4 weeks.
If you stop treatment with Omvoh
Do not stop using Omvoh without first discussing it with your doctor. If you discontinue treatment, symptoms of ulcerative colitis may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Skin rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Infusion-related allergic reaction (e.g. itching, hives)
  • Increased blood levels of liver enzymes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
"Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Do not place the syringes in a microwave, run hot water over them, or leave them in direct sunlight.
Do not shake the pre-filled syringe.
Keep in the original packaging to protect from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of any medicine via wastewater. Ask your doctor, nurse, or pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. Each pre-filled syringe contains 200 mg of mirikizumab in 2 mL of solution.
  • The other components are histidine, monohydrochloride histidine, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a clear glass cartridge contained in a single-use syringe. Its colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 1 pre-filled syringe of 200 mg and in multiple packs containing 3 cartons, each with 1 pre-filled syringe of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Instructions for use

Omvoh 200 mg solution for injection in pre-filled syringe

mirikizumab

Omvoh 200 mg medical device with white body and flat handle, equipped with a blue plunger on the left and a

Read these instructions before injecting yourself with Omvoh. Follow all instructions step by step.
Important information you should know before injecting yourself with Omvoh:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled syringe. Do not inject yourself or anyone else until you have been shown how to inject Omvoh.
  • The pre-filled syringe contains 1 dose of Omvoh. Each Omvoh pre-filled syringe is for single use only. Do not share or reuse the syringe. This could transmit or cause an infection.
  • Healthcare professionals can help you decide where on your body to inject the dose. You may also read the "Choosing the injection site" section of these instructions to help you select the most suitable area.
  • If you have vision problems, do not use the Omvoh pre-filled syringe without the help of a caregiver.
  • Keep these instructions for use and refer to them as needed.

Before using the Omvoh syringe, read and carefully follow all instructions step by step.
Parts of the Omvoh pre-filled syringe
Upper part

Technical diagram of a pre-filled syringe showing annotations for blue plunger, transparent body with green label, and thin needle at the bottom

Thumb button
Blue plunger rod
Grip
Grey syringe plunger
Syringe barrel containing the medicine
Needle
Needle cap
Lower part
Preparing the Omvoh injection
Remove the syringe from the refrigerator Keep the needle cap on the syringe until you are ready to inject.
Leave the syringes at room temperature for 45 minutes before starting the injection.
Do not heat the syringe in a microwave, run warm water over it, or leave it in direct sunlight.
Do not use the syringe if the medicine has been frozen.
Do not shake the syringe.
Prepare necessary supplies You will need:

  • 1 alcohol wipe
  • 1 cotton ball or gauze pads
  • 1 sharps disposal container (see "Disposal of the Omvoh syringe")

Inspect the syringe and medicine Make sure you have the correct medicine. The liquid inside should be clear. It may range from colourless to slightly yellow.
Expiry date
Do not use the syringe and dispose of it as instructed by healthcare professionals if:

  • it appears damaged
  • the medicine is cloudy, discoloured, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen
Technical diagram of a white medical device with a centrally located black indicator circled in red and a black arrow pointing downward

Prepare for injection Wash your hands with soap and water before injecting Omvoh.
Choosing the injection site Healthcare professionals can help you choose the most suitable injection site.

Human body schematic with blue-highlighted areas on

You or another person • You or another person may inject the medicine into the stomach (abdomen) area. Do not inject within 5 centimetres around the navel.

  • You or another person may inject the medicine into the front of the thighs. This area must be at least 5 centimetres above the knee and 5 centimetres below the groin.

  • Another person may give you the injection in the back of the upper arm.

  • Do not inject in areas where the skin is tender, bruised, red, or hardened. Another person must give the injection in this area. Clean the injection site with an alcohol wipe. Allow the injection site to dry before injecting the medicine.

Injecting Omvoh

Two hands separating a medical device consisting of a syringe body with a blue plunger and a white protective cap indicated by a red arrow

Open the syringe

  • Keep the needle cap on until you are ready to inject.
  • Remove the needle cap and dispose of it in household waste.
  • Do not replace the needle cap. This could damage the needle or cause accidental injury.
  • Do not touch the needle.

Insert

Technical drawing showing a hand holding an injector and the
  • Gently pinch and hold the skin at the injection site.
  • Insert the needle at a 45-degree angle.

Inject

A hand holding a white medical device with a blue button pressing it against the skin of the thigh indicated by a red downward arrow

  • Slowly press the thumb button to push the plunger all the way down until all the medicine is injected.

  • The grey syringe plunger must be fully depressed to the end of the syringe needle.

  • When the injection is complete, the blue plunger rod should become visible through the syringe barrel, as shown. Blue plunger rod

  • Remove the needle from the skin and gently release the skin.

  • If bleeding occurs at the injection site, press a cotton ball or gauze pad over the site.

  • Do not rub the injection site.

  • Do not replace the needle cap on the pre-filled syringe.

Diagram of a transparent syringe with an internal blue plunger and a gray base with a thin metal needle at the tip

Disposal of the Omvoh syringe

A hand holding a white medical device with a blue button above a disposal container for needles and sharp objects

Dispose of the used syringe

  • Immediately place the used syringe into a sharps disposal container after use. Do not throw the syringe directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • can be closed with a tight, puncture-resistant lid that prevents sharp objects from sticking out
    • remains upright and stable during use
    • is leak-resistant
    • is properly labelled to warn of hazardous waste inside.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. There may be local laws regarding the disposal of needles and syringes.
  • Do not recycle the used sharps disposal container.
  • For further information on proper disposal of the container, ask your healthcare provider about available options in your area.

Frequently asked questions
Q. What if I let my syringe warm up for more than 45 minutes before injection?
A. The syringe can remain at room temperature up to 30°C for up to 2 weeks.
Q. What if I see air bubbles in my syringe?
A. It is normal to have air bubbles in the syringe. They are not dangerous and will not affect the dose.
Q. What if there is a drop of liquid at the tip of the needle when I remove the needle cap?
A. It is normal to see a drop of liquid at the tip of the needle. This is not dangerous and will not affect the dose.
Q. What if I cannot push the plunger?
A. If the plunger is blocked or damaged:

  • Do not continue using the syringe
  • Remove the needle from the skin
  • Do not use the syringe. Speak with your doctor or pharmacist to obtain a new one.

Q. What if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. How can I tell if my injection is complete?
A. When the injection is complete:

  • The blue plunger rod must be visible through the syringe barrel.
  • The grey syringe plunger must be fully depressed to the end of the syringe needle.

Read the entire Omvoh package leaflet included inside this package for more information about this medicine.

Package leaflet: Information

for the patient
Omvoh 100 mg solution for injection in pre-filled syringe
Omvoh 200 mg solution for injection in pre-filled syringe
mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. Possible side effects
  4. How to store Omvoh
  5. How to use Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody.
Monoclonal antibodies are proteins that specifically recognise and bind to certain target proteins in the body. Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with Crohn's disease.

Crohn's disease
Crohn's disease is a chronic inflammatory condition of the digestive tract. If you have active Crohn's disease, you will first be given other medications. If you do not respond adequately or cannot tolerate these medications, Omvoh may be given to reduce the signs and symptoms of Crohn's disease, such as diarrhoea, abdominal pain, fatigue, and urgency.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • if you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure you inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle aches, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether you need any vaccinations before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are about to receive any vaccination. Some
types of vaccines (live vaccines) should not be administered while using Omvoh.
Allergic reactions

  • Omvoh may potentially cause severe allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a severe allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of throat tightness, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
monitor whether your liver is functioning normally. If blood test results are abnormal, your doctor
may stop treatment with Omvoh and perform further liver tests to determine the cause.
Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age, as it has not been studied
in this age group.
Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently using, have recently used, or might use any other medicines
  • if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh in pregnant women are unknown. If you are a woman of childbearing potential, you should avoid
becoming pregnant and must use an effective method of contraception while using Omvoh and for
at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.
Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.
Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe, equivalent to 0.9 mg per
maintenance dose for the treatment of Crohn’s disease. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.
Dose and duration of Omvoh treatment
Your doctor will decide how much Omvoh you need and for how long. Omvoh is intended for long-term
treatment. Your doctor or nurse will regularly monitor your condition to ensure the
treatment is having the desired effect.
Crohn's disease

  • Initial treatment: The first dose of Omvoh is 900 mg (3 vials of 300 mg each), administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 90 minutes. After the first dose, you will receive another 900 mg dose of Omvoh 4 weeks later, and again 4 weeks after that.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be administered by subcutaneous injection ("subcutaneous route"). This dose will be given every 4 weeks thereafter. The 300 mg maintenance dose will be administered as 2 injections: one containing 100 mg (1 mL) of Omvoh and one containing 200 mg (2 mL) of Omvoh. The injections may be given in any order.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse should decide whether you should
self-inject Omvoh after receiving proper training in subcutaneous injection technique. It is important
not to attempt self-injection until you have been trained by your doctor or
nurse. Your doctor or nurse will provide the necessary training.
A caregiver may also administer the Omvoh injection to you after receiving adequate instructions.
Use a reminder method, such as a note on a calendar or diary, to help you remember the next dose and avoid forgetting or repeating administration of the medicine.
If you receive more Omvoh than you should
If you have received more Omvoh than prescribed or the dose was administered earlier than scheduled,
inform your doctor.
If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, resume administration every 4 weeks.
If you stop treatment with Omvoh
Do not stop using Omvoh without first speaking to your doctor. If you stop treatment,
disease symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very Common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Skin rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Infusion-related allergic reaction (e.g. itching, urticaria)
  • Increased levels of liver enzymes in the blood

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C - 8 °C). Do not freeze.
Do not place the syringes in a microwave, run hot water over them, or expose them to direct sunlight.
Do not shake the pre-filled syringe.
Keep in the original packaging to protect from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of medicines via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. One pre-filled syringe contains 100 mg of mirikizumab in 1 mL of solution and one pre-filled syringe contains 200 mg of mirikizumab in 2 mL of solution.
  • The other components are histidine, monohydrochloride histidine, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge contained in a disposable syringe. Its
colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 2 pre-filled syringes and in multiple packs containing
3 cartons, each with 2 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos
Tél: +33-(0) 1 55 49 34 34 Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba,
Tel: + 353-(0) 1 661 4377 d.o.o.
Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg injectable solution in pre-filled syringe, 200 mg injectable solution in pre-filled syringe

mirikizumab
2 pre-filled syringes: 1 syringe containing 100 mg and 1 syringe containing 200 mg

Two Omvoh injection pens in white and blue, one 100 mg and one 200 mg, shown mirrored with colored labels and ergonomic grips

Read these instructions before injecting Omvoh. Follow all instructions step by step.

  • Two Omvoh injections are required for a complete dose for the treatment of Crohn’s disease: one 100 mg syringe and one 200 mg syringe.
  • Inject one pre-filled syringe of Omvoh immediately followed by the second pre-filled syringe of Omvoh.

Also keep in mind:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled syringe. Do not inject yourself or anyone else until you have been shown how to inject Omvoh.
  • Each Omvoh pre-filled syringe is for single use only. Do not share or reuse the syringe. This could transmit or acquire an infection.
  • Healthcare professionals can help you decide where on your body to inject the dose. You may also read the "Choosing an injection site" section of these instructions to help you select the most suitable area.
  • If you have vision problems, do not use the Omvoh pre-filled syringe without the help of a caregiver.
  • Keep these instructions for use and refer to them as needed.

Before using Omvoh pre-filled syringes, read and carefully follow all instructions step by step.
2 syringes = complete 300 mg dose
After the first injection, select a new injection site at least 5 centimeters away and clean it.
With the second syringe, repeat steps 1–3 immediately after the first injection.
Two syringes must be injected to complete the full 300 mg dose.
Parts of the Omvoh pre-filled syringe
Inject both syringes in any order for a complete 300 mg dose.
The 200 mg syringe is larger than the 100 mg syringe.
Upper part

Two pre-filled Omvoh syringes of 200 mg and 100 mg with blue grips and white bodies, placed side by side with two white protective caps and guideline markings

Thumb button
Blue plunger rod
Grip
Gray syringe plunger
Syringe barrel containing the medicine
Needle
Needle cap
Lower part
100 mg + 200 mg = 1 complete dose
IMPORTANT:

  • Two injections are required for a complete dose for the treatment of Crohn’s disease: one syringe with 100 mg and one syringe with 200 mg.
  • Inject one syringe immediately followed by the other syringe.

Preparing the Omvoh injection
Remove syringes from the refrigerator Take 2 syringes out of the refrigerator.
Leave the needle cap on the syringe until you are ready to inject.
Allow the syringes to warm to room temperature for 45 minutes before starting the injection.
Do not heat the syringes in a microwave, run warm water over them, or leave them in direct sunlight.
Do not use the syringes if the medicine has been frozen.
Do not shake the syringes.

Prepare necessary supplies You will need:

  • 2 alcohol wipes
  • 2 cotton balls or gauze pads
  • 1 sharps disposal container (see "Disposal of the Omvoh syringe")

Inspect the syringes and medicine Make sure you have the correct medicine. The liquid inside should be clear. It may be colorless to Expiry date slightly yellow.

Medical diagram showing a black arrow pointing to a dark horizontal bar enclosed in a red oval on a white device

Do not use the syringe and dispose of it as instructed by healthcare professionals if:

  • the syringe appears damaged
  • the medicine is cloudy, discolored, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen

Prepare for injection Wash your hands with soap and water before injecting Omvoh.
Choose the injection site Healthcare professionals can help you choose the most suitable injection site.

Diagram of a human body showing injection sites highlighted in blue on
  • You or another person may inject the medicine in the stomach area (abdomen). Do not inject within 5 centimeters of the navel.
  • You or another person may inject the medicine in the front part of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
  • Another person may administer the injection in the upper outer area of the arm.
  • Do not inject in the exact same spot each time. For example, if the first injection was in the abdomen, the second injection—for a complete dose—could be in another area of the abdomen.
  • Do not inject in areas where the skin is tender, bruised, red, or hardened.

Another person must
inject in this area
Clean the injection site with an alcohol wipe. Allow the injection site to dry before injecting the medicine.
Injecting Omvoh

Two hands holding a syringe with a horizontal movement to the right indicated by a red arrow for injection

Open the syringe

  • Leave the needle cap on until you are ready to inject.
  • Remove the needle cap and dispose of it in household waste.
  • Do not replace the needle cap. This could damage the needle or cause accidental injury.
  • Do not touch the needle.
Illustration showing a hand holding a syringe angled at 45 degrees for injection

Insert

  • Gently pinch and hold the skin at the injection site.
  • Insert the needle at a 45-degree angle.

Inject

A hand holding a medical device with a blue button for injection

  • Slowly press the thumb button to push the plunger all the way down until all the medicine is injected.

  • The gray syringe plunger must be fully depressed to the end of the syringe needle.

  • When the injection is complete, the blue plunger rod should become visible through the syringe barrel, as shown.

  • Remove the needle from the skin and gently release the skin.

  • If bleeding occurs at the injection site, press a cotton ball or gauze pad over the site.

  • Do not rub the injection site.

  • Do not recap the needle on the pre-filled syringe.

Two injections are required for a complete dose. Inject one syringe immediately followed by the other syringe.
Disposal of the Omvoh syringe

A hand holding an injection pen with a blue button above a disposal container for sharp objects and medical waste

Dispose of the used syringe

  • Immediately place the used syringe in a sharps disposal container after use. Do not throw the syringe directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • can be closed with a tight-fitting, puncture-resistant lid, preventing sharp objects from protruding
    • remains upright and stable during use
    • is leak-proof
    • is properly labeled to warn of hazardous waste inside.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. There may be local laws regarding the disposal of needles and syringes.
  • Do not recycle a used sharps disposal container.
  • For more information on proper disposal of the container, ask your healthcare provider about available options in your area.

Frequently asked questions
Q. What if I let my syringe warm for more than 45 minutes before injection?
A. The syringe can remain at room temperature up to 30°C for up to 2 weeks.
Q. What if I see air bubbles in my syringe?
A. It is normal to have air bubbles in the syringe. They are not dangerous and will not affect the dose.
Q. What if there is a drop of liquid on the needle tip when I remove the needle cap?
A. It is normal to see a drop of liquid on the needle tip. This is not dangerous and will not affect the dose.
Q. What if I cannot push the plunger?
A. If the plunger is stuck or damaged:

  • Do not continue using the syringe
  • Remove the needle from the skin
  • Do not use the syringe. Contact your doctor or pharmacist to obtain a new one.

Q. What if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. How can I tell if my injection is complete?
A. When the injection is complete:

  • The blue plunger rod must be visible through the syringe barrel.
  • The gray syringe plunger must be fully depressed to the end of the syringe needle.

Read the entire Omvoh package leaflet included in this package for more information about this medicine.

Patient information leaflet

Omvoh 100 mg solution for injection in a pre-filled pen

mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with ulcerative colitis.
Ulcerative colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to you to reduce the signs and symptoms of ulcerative colitis, such as diarrhoea, abdominal pain, urgency, and rectal bleeding.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • If you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle pain, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are about to receive any vaccination. Some
types of vaccines (live vaccines) should not be administered while using Omvoh.

Allergic reactions

  • Omvoh may potentially cause serious allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a serious allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of throat tightness, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to
check whether your liver is functioning normally. If blood test results are abnormal, your doctor
may stop treatment with Omvoh and perform further liver tests to determine the cause.

Children and adolescents
Omvoh is not recommended for children and adolescents under 18 years of age, as it has not been studied
in this age group.

Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently using, have recently used, or might use any other medicines
  • if you have recently received or are about to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh in pregnant women are unknown. If you are a woman of childbearing potential, it is advisable to avoid becoming pregnant and to use an effective method of contraception while using Omvoh and for at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using
this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive vehicles or operate machinery.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each pen, equivalent to 0.6 mg per maintenance dose for the treatment of ulcerative colitis. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.
How much Omvoh is administered and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is intended for long-term
treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is
achieving the desired effect.
Ulcerative colitis

  • Treatment initiation: The initial dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another dose of Omvoh 300 mg four weeks later, and again after another four weeks. If an adequate therapeutic response is not achieved after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16, and 20.
  • Maintenance therapy: Four weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered as a subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 200 mg maintenance dose will be given as 2 injections, each containing 100 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse must decide whether you should self-inject Omvoh after receiving proper training in subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.
A caregiver may also administer the Omvoh injection to you after receiving adequate instructions.
Use a reminder method, such as a note on a calendar or diary, to help you remember your next dose and avoid missing or repeating administration of the medicine.
If you receive more Omvoh than you should
If you have received more Omvoh than prescribed or the dose was administered earlier than scheduled, inform your doctor.
If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, resume your regular dosing schedule every 4 weeks.
If you stop treatment with Omvoh
Do not stop using Omvoh without first talking to your doctor. If you discontinue treatment, symptoms of ulcerative colitis may return.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Skin rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Allergic reaction related to infusion (e.g. itching, hives)
  • Increased blood levels of liver enzymes

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after
"Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Do not place the pens in the microwave, run hot water over them, or expose them to direct sunlight.
Do not shake the pre-filled pen.
Store in the original packaging to protect it from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled pen is damaged, or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of any medicine via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. Each pre-filled pen contains 100 mg of mirikizumab in 1 mL of solution.
  • The other components are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a clear glass cartridge contained in a disposable single-use pen.
Its colour may vary from colourless to slightly yellow.
Omvoh is available in packs of 2 pre-filled pens containing 100 mg, in multiple packs of 2 cartons, each containing 2 pre-filled pens of 100 mg, and in multiple packs of 3 cartons, each containing 2 pre-filled pens of 100 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg solution for injection in a prefilled pen

mirikizumab
2 prefilled pens: 1 pen containing 100 mg and 1 pen containing 100 mg

Two Omvoh 100 mg injection pens arranged horizontally with blue text and green icons on white background and transparent caps

Read these instructions before injecting Omvoh. Follow all instructions step by step.

  • Two injections of Omvoh are required for a complete dose for the treatment of ulcerative colitis.
  • Inject 1 pen of Omvoh immediately followed by the second pen of Omvoh.

Also keep in mind:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pen. Do not inject yourself or anyone else until you have been shown how to inject Omvoh.
  • Each Omvoh pen is for single use only. Do not share or reuse the pen. You could transmit or acquire an infection.
  • Healthcare professionals can help you decide where on your body to inject the dose. You may also read the "Choosing the injection site" section of these instructions to help you select the most suitable area.
  • If you have vision or hearing impairments, do not use the Omvoh prefilled pen without the assistance of a caregiver.
  • Keep these instructions for use and refer to them whenever necessary.

Before using Omvoh prefilled pens, read and carefully follow all instructions step by step.
Parts of the Omvoh pen
Upper part

Two Omvoh 100 mg injection pens with black lines indicating different parts of the device and the lower protective cap

Injection button
blue
Lock ring
Lock/unlock
symbols
Medicine
Needle
Transparent base
Grey cap of the
base
Lower part
100 mg + 100 mg = 1 complete dose
IMPORTANT:

  • Two injections are required for a complete dose for the treatment of ulcerative colitis.
  • Inject one pen immediately followed by the second pen.

Preparing the Omvoh injection
Remove the pens from the refrigerator Take 2 pens out of the refrigerator.
Leave the grey cap of the base on until you are ready
for injection.
Allow the pens to warm to room temperature for 30 minutes before starting the injection.
Do not heat the pens in a microwave, run warm water over them, or leave them in direct sunlight.
Do not use the pens if the medicine has been frozen.
Do not shake the pens.

Prepare the necessary items You will need:

  • 2 alcohol wipes
  • 2 cotton balls or gauze pads
  • 1 sharps disposal container (see "Disposal of Omvoh pens")

Inspect the pen and medicine Make sure you have the correct medicine. The liquid inside should be clear, ranging from colourless to slightly yellow.
Expiry
Do not use the pens and dispose of them as instructed by healthcare professionals if:

Pen-shaped medical device with a dark rectangular indicator highlighted by a red circle and a black arrow pointing downward
  • the pen appears damaged
  • the medicine is cloudy, discoloured, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen

Prepare for injection Wash your hands with soap and water before injecting Omvoh.
Choosing the injection site Healthcare professionals can help you select the most suitable injection site.

Diagram of two human figures indicating injection sites on abdomen, upper arm, and thighs with blue-highlighted areas
  • You or another person may inject the medicine into the stomach (abdomen). Do not inject within 5 centimetres of the navel. Abdomen • You or another person may inject the medicine into the front of the thighs. This area should be at least 5 centimetres above the knee and 5 centimetres below the groin.
  • Another person may inject the medicine into the back of the upper arm.
  • Do not inject in exactly the same spot each time. For example, if the first injection was in the abdomen, the second injection for a complete dose could be in a different area of the abdomen.
  • Do not inject in areas where the skin is tender, bruised, red, or hardened.

Clean the injection site with an alcohol wipe. Allow the injection site to dry before injecting the medicine.
Thigh
Injecting Omvoh

Detail of a medical container with numerical scale 2 and 3 and icons of a locked and unlocked lock circled in black to indicate safety status

1 Remove the cap from the pen

Stylized gray icon of a closed lock with arched top and rectangular base on white background

Ensure the pen is locked.
Leave the grey cap of the base on until you are ready for injection.

A hand holding a transparent injection pen while the
  • Unscrew and remove the grey cap from the base and dispose of it in household waste.
  • Do not replace the grey cap on the base – this could damage the needle.
  • Do not touch the needle.
Hands holding an injection pen on the thigh with an inset showing rotation of a dial with open and closed lock icons

2 Position and unlock

  • Place and hold the transparent base flat and firmly against the skin. Base
    transparent
Stylized green icon of an open lock with arched top turned to the right on white background

Hold the base against the skin and rotate the lock ring to the unlock position.

A hand holding a pre-filled syringe to inject medication into the

3 Press and hold for up to 10 seconds

  • Press and hold the blue injection button. You will hear a loud click (injection started).
  • Continue to hold the transparent base firmly against the skin. You will hear a second loud click approximately 10 seconds after the first (injection completed).
Detail of a transparent medical device with a black arrow indicating an internal cylindrical, grooved component
  • You will know the injection is complete when the grey plunger becomes visible.
  • Remove the pen from the skin. Plunger
  • If bleeding occurs at the injection site, apply a cotton ball or gauze pad to the site. grey
  • Do not rub the injection site.

Two injections are required for a complete dose. Inject one pen immediately followed by the second pen.
Disposal of Omvoh pens
Dispose of used pens

A hand holding an injection pen horizontally ready to be inserted into a sharps waste disposal container
  • Immediately after use, place the used pen in a sharps disposal container. Do not throw the pen directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • can be closed with a tight-fitting, puncture-resistant lid, preventing sharp objects from protruding
    • remains upright and stable during use
    • is leak-resistant
    • is properly labelled to warn of hazardous waste inside.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. There may be local laws governing the disposal of needles and pens.
  • Do not recycle the used sharps disposal container.
  • For further information on proper disposal of the container, ask your doctor about available options in your area.

Frequently asked questions
Q. What if I let my pen warm for more than 30 minutes before injection?
A. The pen can remain at room temperature up to 30 °C for a maximum of 2 weeks.
Q. What if I see air bubbles in my pen?
A. It is normal to have air bubbles in the pen. They are not dangerous and will not affect the dose.
Q. What if there is a drop of liquid at the tip of the needle when I remove the grey base cap?
A. It is normal to see a drop of liquid at the needle tip. This will not harm you or affect your dose.
Q. What if I unlock the pen and press the blue injection button all the way, completing the injection?
A. Do not remove the grey base cap. Do not use the pen. Speak to your doctor or pharmacist to obtain a new one.
Q. Do I need to hold down the blue injection button until the injection is complete?
A. It is not necessary to hold down the blue injection button, but doing so may help keep the pen stable and steady against the skin.
Q. What if the needle does not retract after the injection?
A. Do not touch the needle or replace the grey base cap. Keep the pen in a safe place to avoid accidental needle sticks and contact your doctor, pharmacist, or nurse.
Q. What if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Apply a cotton ball or gauze pad to the injection site. Do not rub the injection site.
Q. What if I heard more than 2 clicks during the injection: 2 loud clicks and one soft click? Did I receive the full injection?
A. Some patients may hear a soft click just before the second loud click. This is normal pen function. Do not remove the pen from the skin until you hear the second loud click.
Q. How can I tell if my injection is complete?
A. After pressing the blue injection button, you will hear 2 loud clicks. The second loud click indicates the injection is complete. You will also see the grey plunger in the upper part of the transparent base.
Read the entire Omvoh patient information leaflet included in this package for more information about this medicine.

Patient information leaflet

Omvoh 200 mg solution for injection in a prefilled pen

mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically recognise and bind to certain target proteins in the body.
Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with ulcerative colitis.
Ulcerative colitis
Ulcerative colitis is a chronic inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of ulcerative colitis, such as diarrhoea, abdominal pain, urgency, and rectal bleeding.

2. What you need to know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • If you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle aches, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of developing active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are scheduled to receive any vaccination. Some
types of vaccines (live vaccines) must not be administered while using Omvoh.

Allergic reactions

  • Omvoh may potentially cause serious allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a serious allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of throat tightness, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to monitor
whether your liver is functioning normally. If blood test results are abnormal, your doctor may stop
treatment with Omvoh and perform additional liver tests to determine the cause.

Children and adolescents
Omvoh is not recommended in children and adolescents under 18 years of age, as it has not been studied
in this age group.

Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently taking, have recently taken, or might take any other medicines
  • if you have recently received or are scheduled to receive a vaccination. Some types of vaccines (live vaccines) must not be administered while you are using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor
before using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of
Omvoh in pregnant women are unknown. If you are a woman of childbearing potential, it is advisable to
avoid becoming pregnant and to use an effective method of contraception while using Omvoh and for
at least 10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, talk to your doctor before using this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each pen, equivalent to 0.6 mg per maintenance dose for the treatment of ulcerative colitis. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as directed by your doctor or nurse. If you have
any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.
Dose and duration of Omvoh treatment
Your doctor will determine how much Omvoh you need and for how long. Omvoh is intended for long-term
treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is having the desired effect.
Ulcerative colitis

  • Induction of treatment: The initial dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 30 minutes. After the first dose, you will receive another 300 mg dose of Omvoh 4 weeks later, and again after another 4 weeks. If an adequate therapeutic response is not achieved after these 3 infusions, your doctor may consider continuing intravenous infusions at weeks 12, 16, and 20.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be administered as a subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 200 mg maintenance dose will be given as 1 injection containing 200 mg of Omvoh. If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh via intravenous infusion.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving proper training on the subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.
A caregiver may also administer the Omvoh injection to you after receiving adequate instructions.
Use a reminder method, such as a note on a calendar or diary, to help you remember the next dose and avoid missing or repeating the administration of the medicine.
If you receive more Omvoh than you should
If you have received more Omvoh than prescribed or if the dose was administered earlier than scheduled, inform your doctor immediately.
If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, continue with your regular schedule every 4 weeks.
If you stop treatment with Omvoh
Do not stop using Omvoh without first talking to your doctor. If you discontinue treatment, symptoms of ulcerative colitis may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Allergic reaction related to infusion (e.g. itching, hives)
  • Increased levels of liver enzymes in blood

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C). Do not freeze.
Do not place the pen in a microwave, run hot water over it, or expose it to direct sunlight.
Do not shake the pre-filled pen.
Store in the original packaging to protect it from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled pen is damaged, or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of any medicine via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Omvoh contains

  • The active substance is mirikizumab. Each pre-filled pen contains 200 mg of mirikizumab in 2 mL of solution.
  • The other components are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a transparent glass cartridge contained in a single-use pen. Its
colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 1 pre-filled pen of 200 mg and in multiple packs containing
3 cartons, each containing 1 pre-filled pen of 200 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.B.E. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Instructions for use

Omvoh 200 mg solution for injection in a pre-filled pen

mirikizumab

Omvoh auto-injector pen 200 mg with white body, blue logo, green label, and gray icons for usage instructions

Read these instructions before injecting Omvoh. Follow all instructions step by step.
Important information you need to know before injecting Omvoh:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pen. Do not inject Omvoh yourself or give it to someone else until you have been shown how to inject Omvoh.
  • The pre-filled pen contains 1 dose of Omvoh. Each Omvoh pen is for single use only. Do not share or reuse the pen. You could transmit or acquire an infection.
  • A healthcare professional can help you decide where on your body to inject the dose. You may also read the "Choosing the injection site" section of these instructions to help you choose the best area for you.
  • If you have vision or hearing problems, do not use the Omvoh pre-filled pen without the help of a caregiver.
  • Keep these instructions for use and refer to them as needed.

Before using Omvoh pens, read and carefully follow all instructions step by step.
Parts of the Omvoh pen
Upper part

Vertical pre-filled syringe with white and green label stating Omvoh 200 mg and black graphic indicators on white background

Injection button
blue
Locking ring
Lock/unlock
symbols
Medicine
Needle
Transparent base
Grey base cap
Lower part
Preparing the Omvoh injection
Take the pen out of the refrigerator Leave the grey base cap on until you are
ready to inject.
Allow the pen to reach room temperature for 45 minutes
before starting the injection.
Do not heat the pen in a microwave, run warm water over it, or leave it in direct sunlight.
Do not use the pen if the medicine has been frozen.
Do not shake the pen.
Prepare necessary supplies You will need:

  • 1 alcohol swab
  • 1 cotton ball or gauze pad
  • 1 sharps disposal container (see "Disposal of Omvoh pens")

Inspect the pen and medicine Make sure you have the correct medicine. The liquid inside should be clear. It may be colorless to Expiry date slightly yellow.

Detail of a medical device with a black arrow pointing to a dark rectangle highlighted by a red circle on a transparent tube

Do not use the pen and dispose of it as instructed by healthcare professionals if:

  • it appears damaged
  • the medicine is cloudy, discolored, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen

Prepare for the injection Wash your hands with soap and water before injecting Omvoh.
Choosing the injection site A healthcare professional can help you choose the most suitable injection site for you.

Schematic of the human body with blue-highlighted areas on
  • You or another person may inject the medicine into the abdominal area (stomach). Do not inject within 5 centimeters around the navel.
    You or another person may inject into these areas.
  • You or another person may inject the medicine into the front of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
  • Another person may inject the medicine into the back of the upper arm.
Schematic drawing of a person's torso and arms viewed from behind with two blue-highlighted areas on the upper part of both arms
  • Do not inject into areas where the skin is tender, bruised, red, or hardened. Another person should inject in a different area.
    Clean the injection site with an alcohol swab. Allow the injection site to dry before injecting the medicine.

Injecting Omvoh

Detail of a medical device with a red circle highlighting a vertical gray bar above a closed lock symbol

1 Remove the cap from the pen

Stylized icon of a gray lock with arched top and a white rectangular slit in the center

Make sure the pen is locked.
Leave the grey base cap on until you are ready to inject.

A hand holding a transparent injection pen while the
  • Unscrew and discard the grey base cap into household waste.
  • Do not replace the grey base cap—this could damage the needle.
  • Do not touch the needle.
Hands holding a white auto-injector on the thigh with an inset showing rotation of the upper part of the device

Transparent base
2 Position and unlock

  • Place and hold the transparent base flat and firmly against the skin.

Hold the base against the skin and rotate

Stylized green icon depicting an open lock with the hook facing right on white background

the locking ring to the unlock position.

A hand holding a white and gray injection pen placed on the

3 Press and hold for up to 15 seconds

  • Press and hold the blue injection button. You will hear a loud click (injection started).
  • Continue to hold the transparent base firmly against the skin. You will hear a second loud click approximately 15 seconds after the first (injection completed).
Detail of a transparent medical device with a red arrow indicating an internal cylindrical section highlighted by a red circle
  • You will know the injection is complete when the grey plunger becomes visible.
  • Remove the pen from the skin. Grey plunger
  • If bleeding occurs at the injection site, press a cotton ball or gauze pad over the site.
  • Do not rub the injection site.

Disposal of Omvoh pens
Dispose of used pens

A hand holding a white injection pen bringing it close to a gray medical waste disposal container
  • Immediately after use, place the used pen in a sharps disposal container. Do not throw the pen directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • can be closed with a tight-fitting, puncture-resistant lid, so that sharp items cannot come out
    • remains upright and stable during use
    • is leak-resistant
    • is properly labeled to warn of hazardous waste inside the container.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. There may be local laws about how to dispose of needles and pens.
  • Do not recycle the used sharps disposal container.
  • For more information on proper disposal of the container, ask your doctor about available options in your area.

Frequently asked questions
Q. What if I let my pen warm up for more than 45 minutes before the injection?
A. The pen can remain at room temperature up to 30 °C for up to 2 weeks.
Q. What if I see air bubbles in my pen?
A. It is normal to have air bubbles in the pen. They are not harmful and will not affect the dose.
Q. What if there is a drop of liquid on the tip of the needle when I remove the grey base cap?
A. It is normal to see a drop of liquid on the tip of the needle. This will not harm you or affect your dose.
Q. What if I unlock the pen and press the blue injection button before completing the injection?
A. Do not remove the grey base cap. Do not use the pen. Speak with your doctor or pharmacist to obtain a new one.
Q. Do I need to hold the blue injection button down until the injection is complete?
A. It is not necessary to hold the blue injection button down, but doing so may help keep the pen steady and firmly against the skin.
Q. What if the needle does not retract after the injection?
A. Do not touch the needle or replace the grey base cap. Keep the pen in a safe place to avoid accidental needle sticks and contact your doctor, pharmacist, or nurse.
Q. What if there is a drop of liquid or blood on the skin after the injection?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. What if I heard more than 2 clicks during the injection: 2 loud clicks and one soft click. Did I receive the full dose?
A. Some patients may hear a soft click just before the second loud click. This is normal pen function. Do not remove the pen from the skin until you hear the second loud click.
Q. How can I tell if my injection is complete?
A. After pressing the blue injection button, you will hear 2 loud clicks. The second loud click indicates that the injection is complete. You will also see the grey plunger in the upper part of the transparent base.
Read the entire Omvoh patient information leaflet included in this package for more information about this medicine.

Patient information leaflet

Omvoh 100 mg solution for injection in a pre-filled pen, 200 mg solution for injection in a pre-filled pen

mirikizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

  1. What Omvoh is and what it is used for
  2. What you need to know before using Omvoh
  3. How to use Omvoh
  4. Possible side effects
  5. How to store Omvoh
  6. Contents of the pack and other information

1. What Omvoh is and what it is used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody.
Monoclonal antibodies are proteins that recognise and specifically bind to certain target proteins in the body. Omvoh works by binding to and blocking a protein in the body called IL-23 (interleukin-23), which is involved in inflammation. By blocking the action of IL-23, Omvoh reduces inflammation and other symptoms associated with Crohn’s disease.

Crohn’s disease
Crohn’s disease is a chronic inflammatory disease of the digestive tract. If you have active Crohn’s disease, you will first be given other medicines. If you do not respond adequately or cannot tolerate these medicines, Omvoh may be given to reduce the signs and symptoms of Crohn’s disease, such as diarrhoea, abdominal pain, fatigue, and urgency.

2. What you should know before using Omvoh

Do not use Omvoh

  • If you are allergic to mirikizumab or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
  • If you have serious active infections (such as active tuberculosis).

Warnings and precautions

  • Talk to your doctor or pharmacist before using this medicine.
  • Your doctor will check your health status before starting treatment.
  • Make sure to inform your doctor about any medical conditions you have before starting treatment.

Infections

  • Omvoh may potentially cause serious infections. Treatment with Omvoh should not be started if you have an active infection until the infection has resolved.
  • After starting treatment, inform your doctor immediately if you develop symptoms of an infection such as: fever, shortness of breath, chills, runny nose, muscle pain, sore throat, cough, or pain during urination.
  • Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
  • Your doctor will examine you and may perform a test for tuberculosis before you start taking Omvoh.
  • If your doctor believes you are at risk of active tuberculosis, they may prescribe medication to treat it.

Vaccinations
Your doctor will check whether vaccinations are needed before starting treatment. Inform your doctor,
pharmacist, or nurse if you have recently received or are scheduled to receive any vaccination. Some
types of vaccines (live vaccines) should not be administered during treatment with Omvoh.

Allergic reactions

  • Omvoh may potentially cause severe allergic reactions.
  • Stop using Omvoh and seek immediate emergency medical help if you develop any of the following symptoms of a severe allergic reaction: skin rash, low blood pressure, fainting, swelling of the face, lips, mouth, tongue, or throat, difficulty breathing, dizziness, feeling of tightness in the throat, or chest tightness.

Liver blood tests
Your doctor will perform blood tests before starting Omvoh and during treatment with Omvoh to monitor
whether your liver is functioning normally. If blood tests show abnormal results, your doctor may stop
treatment with Omvoh and perform further liver tests to determine the cause.

Children and adolescents
Omvoh is not recommended for children and adolescents under 18 years of age, as it has not been studied
in this age group.

Other medicines and Omvoh
Inform your doctor, pharmacist, or nurse

  • if you are currently taking, have recently taken, or might take any other medicines.
  • if you have recently received or are scheduled to receive a vaccination. Some types of vaccines (live vaccines) should not be administered while using Omvoh.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning a pregnancy, consult your doctor before
using this medicine. It is preferable to avoid using Omvoh during pregnancy. The effects of Omvoh in
pregnant women are unknown. If you are a woman of childbearing potential, you should avoid becoming
pregnant and use an effective method of contraception during treatment with Omvoh and for at least
10 weeks after the last dose of Omvoh.
If you are breastfeeding or planning to breastfeed, speak with your doctor before using this medicine.

Driving and using machines
It is unlikely that Omvoh will affect your ability to drive or operate machinery.

Omvoh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each pen, equivalent to 0.9 mg per maintenance
dose for the treatment of Crohn’s disease. Polysorbates may cause allergic reactions. Inform your doctor
if you have known allergies.

3. How to use Omvoh

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts about how to use the medicine, consult your doctor, nurse, or pharmacist.

How much Omvoh is administered and for how long

Your doctor will decide how much Omvoh you need and for how long. Omvoh is intended for long-term treatment. Your doctor or nurse will regularly monitor your condition to ensure the treatment is achieving the desired effect.

Crohn’s disease

  • Initial treatment: The first dose of Omvoh is 900 mg (3 vials of 300 mg each), administered by your doctor as an intravenous infusion (intravenous drip into a vein in the arm) lasting at least 90 minutes. After the first dose, you will receive another 900 mg dose of Omvoh 4 weeks later, and again 4 weeks after that.
  • Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 300 mg will be administered by subcutaneous injection ("subcutaneous route"), and then every 4 weeks thereafter. The 300 mg maintenance dose will be given as two injections: one containing 100 mg (1 mL) of Omvoh and one containing 200 mg (2 mL) of Omvoh. The injections may be administered in any order.

Your doctor or nurse will inform you when to switch to subcutaneous injections.
During maintenance therapy, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving proper training on the subcutaneous injection technique. It is important not to attempt self-injection until you have been trained by your doctor or nurse. Your doctor or nurse will provide the necessary training.
A caregiver may also administer the Omvoh injection to you after receiving appropriate instructions.

Use a reminder method, such as a note on a calendar or in a diary, to help you remember your next dose and avoid missing or repeating a dose.

If you receive more Omvoh than you should

If you have received more Omvoh than prescribed or if the dose was administered earlier than scheduled, inform your doctor immediately.

If you forget to use Omvoh

If you have forgotten to inject a dose of Omvoh, inject it as soon as possible. Then, resume your regular dosing schedule every 4 weeks.

If you stop treatment with Omvoh

Do not stop using Omvoh without first talking to your doctor. If you stop treatment, your disease symptoms may return.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

  • Reactions at the injection site (e.g. skin redness, pain)

Common (may affect up to 1 in 10 people)

  • Upper respiratory tract infections (infections of the nose and throat)
  • Joint pain
  • Headache
  • Rash

Uncommon (may affect up to 1 in 100 people)

  • Herpes zoster
  • Infusion-related allergic reaction (e.g. itching, hives)
  • Increased blood levels of liver enzymes

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omvoh

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C–8 °C). Do not freeze.
Do not place the syringes in the microwave, run hot water over them, or expose them to direct sunlight.
Do not shake the pre-filled syringe.
Keep in the original packaging to protect from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not exceeding 30°C.
If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or if the solution is cloudy, clearly brown, or contains particles.
This medicine is for single use only.
Do not dispose of any medicine via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omvoh contains

  • The active substance is mirikizumab. One pre-filled pen contains 100 mg of mirikizumab in 1 mL of solution and one pre-filled pen contains 200 mg of mirikizumab in 2 mL of solution.
  • The other components are histidine, histidine monohydrochloride, sodium chloride, mannitol (E 421), polysorbate 80 (E 433), water for injections.

Description of the appearance of Omvoh and contents of the pack
Omvoh is a solution in a clear glass cartridge contained in a single-use pen. Its colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 2 pre-filled pens and in multiple packs containing 3 cartons, each with 2 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Manufacturer
Lilly France S.A.S.
Rue du Colonel Lilly
67640 Fegersheim
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder in your country:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia, s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A. Pārstāvniecība Latvijā Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/.

Instructions for use

Omvoh 100 mg injectable solution in pre-filled pen, 200 mg injectable solution in pre-filled pen

mirikizumab
2 pre-filled pens: 1 pen of 100 mg and 1 pen of 200 mg

Two Omvoh injection pens, one 200 mg with green label and one 100 mg with blue label, arranged horizontally on white background

Read these instructions before injecting Omvoh. Follow all instructions step by step.

  • Two Omvoh injections are required for a complete dose for the treatment of Crohn’s disease: one 100 mg pen and one 200 mg pen.
  • Inject one pre-filled pen of Omvoh immediately followed by the other pre-filled pen of Omvoh.

Please also keep in mind:

  • Healthcare professionals must show you how to prepare and inject Omvoh using the pre-filled pen. Do not inject yourself or someone else until you have been shown how to inject Omvoh.
  • Each Omvoh pre-filled pen is for single use only. Do not share or reuse the pen. This could transmit or acquire an infection.
  • Healthcare professionals can help you decide where on your body to inject the dose. You may also read the "Choosing the injection site" section of these instructions to help you select the most suitable area.
  • If you have vision or hearing impairments, do not use the Omvoh pre-filled pen without the assistance of a caregiver.
  • Keep these instructions for use and refer to them as needed.

Before using Omvoh pre-filled pens, read and carefully follow all instructions step by step.
2 pens = complete 300 mg dose
After the first injection, select a new injection site at least 5 centimeters away and clean it.
With the second pen, repeat steps 1–3 immediately after the first injection.
Two pens must be injected to complete the full 300 mg dose.
Parts of the Omvoh pen
Inject both pens in any order for a complete 300 mg dose.
The 200 mg pen is larger than the 100 mg pen.
Upper part

Two Omvoh injection pens 200 mg and 100 mg with numerical indicators and detailed components, and two separate gray circular bases

Blue injection button
Locking ring
Lock/unlock symbols
Medicine
Needle
Transparent base
Grey cap of the base
Lower part
100 mg + 200 mg = 1 complete dose
IMPORTANT:

  • Two injections are required for a complete dose for the treatment of Crohn’s disease: one 100 mg pen and one 200 mg pen.
  • Inject one pen immediately followed by the other pen.

Preparing the Omvoh injection
Remove pens from the refrigerator Remove 2 pens from the refrigerator.
Leave the grey base cap on until you are ready for injection.
Allow the pens to reach room temperature for 45 minutes before starting the injection.
Do not heat the pens in a microwave, run warm water over them, or leave them in direct sunlight.
Do not use the pens if the medicine has been frozen.
Do not shake the pens.

Prepare necessary supplies You will need:

  • 2 alcohol wipes
  • 2 cotton balls or gauze pads
  • 1 sharps disposal container (see "Disposal of Omvoh pens")

Inspect the pen and medicine Make sure you have the correct medicine. The liquid inside should be clear, ranging from colourless to slightly yellow.
Expiry date
Do not use the pens and dispose of them as instructed by healthcare professionals if:

Detail of a transparent medical device with a red arrow pointing to a black rectangle at the
  • the pen appears damaged
  • the medicine is cloudy, discoloured, or contains particles
  • the expiry date printed on the label has passed
  • the medicine has been frozen

Prepare for injection Wash your hands with soap and water before injecting Omvoh.
Choose the injection site Healthcare professionals can help you select the most suitable injection site.

Human body schematic showing injection sites highlighted in blue on
  • You or another person may inject the medicine into the stomach (abdomen). Do not inject within 5 centimeters around the navel.
  • You or another person may inject the medicine into the front of the thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
  • Another person may inject the medicine into the back of the upper arm.
  • Do not inject in the exact same spot each time. For example, if the first injection was in the abdomen, the second injection for a complete dose could be in another area of the abdomen.
  • Do not inject in areas where the skin is tender, bruised, red, or hardened.

Clean the injection site with an alcohol wipe. Allow the injection site to dry before injecting the medicine.
Another person must inject here.
Injecting Omvoh

White medical device with numerical indicators 2 and 3, a vertical gray bar, and a lock symbol, all highlighted by a red circle

1 Remove the cap from the pen

Stylized icon of a gray lock with arched top and a white rectangular slit in the center

Ensure the pen is locked.
Leave the grey base cap on until you are ready for injection.

A hand holding a transparent injection pen while the
  • Unscrew and remove the grey cap from the base and dispose of it in household waste.
  • Do not replace the grey base cap—this could damage the needle.
  • Do not touch the needle.

2 Position and unlock

  • Place and hold the transparent base flat and firmly against the skin. Transparent base
Hands holding an injection pen against the skin of the Stylized green icon of an open lock with arched top facing right on white background

Hold the base against the skin and rotate the locking ring to the unlock position.

A hand holding an injection pen pressed against the skin of the

3 Press and hold for up to 15 seconds
15 seconds

  • Press and hold the blue injection button. You will hear a loud click (injection started).
  • Continue to hold the transparent base firmly against the skin. You will hear a second loud click approximately 15 seconds after the first (injection completed).
Detail of a transparent medical device with a red arrow indicating an internal section with horizontal grooves circled in red
  • You will know the injection is complete when the grey plunger becomes visible. Grey plunger
  • Remove the pen from the skin.
  • If bleeding occurs at the injection site, press a cotton ball or gauze pad over the site.
  • Do not rub the injection site.

Two injections are required for a complete dose. Inject one pen immediately followed by the other pen.
Disposal of Omvoh pens

A hand holding an injection pen horizontally above a biological hazard medical waste disposal container

Dispose of used pens

  • Immediately place the used pen in a sharps disposal container after use. Do not throw the pen directly into household waste.
  • If you do not have a sharps disposal container, you may use a household container that:
    • is made of heavy-duty plastic
    • can be closed with a tight-fitting, puncture-resistant lid, preventing sharp objects from coming out
    • remains upright and stable during use
    • is leak-resistant
    • is properly labelled to warn of hazardous waste inside.
  • When the sharps disposal container is nearly full, follow your community guidelines for proper disposal. Local regulations may apply to the disposal of needles and pens.
  • Do not recycle the used sharps disposal container.
  • For more information on proper disposal of the container, ask your doctor about available options in your area.

Frequently asked questions
Q. What happens if I let my pen warm up for more than 45 minutes before injection?
A. The pen can remain at room temperature up to 30 °C for a maximum of 2 weeks.
Q. What if I see air bubbles in my pen?
A. It is normal to have air bubbles in the pen. They are not dangerous and will not affect the dose.
Q. What if there is a drop of liquid on the needle tip when I remove the grey base cap?
A. It is normal to see a drop of liquid on the needle tip. This will not harm you or affect your dose.
Q. What if I unlock the pen and press the blue injection button before completing the injection?
A. Do not remove the grey base cap. Do not use the pen. Speak with your doctor or pharmacist to obtain a new one.
Q. Do I need to hold the blue injection button until the injection is complete?
A. It is not necessary to hold the blue injection button, but doing so may help keep the pen stable and steady against the skin.
Q. What if the needle does not retract after injection?
A. Do not touch the needle or replace the grey base cap. Keep the pen in a safe place to avoid accidental needle sticks and contact your doctor, pharmacist, or nurse.
Q. What if there is a drop of liquid or blood on the skin after injection?
A. This is normal. Press a cotton ball or gauze pad over the injection site. Do not rub the injection site.
Q. What if I heard more than 2 clicks during the injection: 2 loud clicks and one soft click. Did I receive the full injection?
A. Some patients may hear a soft click just before the second loud click. This is normal pen function. Do not remove the pen from the skin until you hear the second loud click.
Q. How can I tell if my injection is complete?
A. After pressing the blue injection button, you will hear 2 loud clicks. The second loud click indicates the injection is complete. You will also see the grey plunger in the upper part of the transparent base.
Read the entire Omvoh patient information leaflet included in this package for more information about this medicine.