OmvoH 300 mg concentrate for solution for infusion

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Omvoh 300 mg concentrate for solution for infusion

mirikizumab

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to others, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Omvoh is and what it is used for
2. What you need to know before receiving 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 specifically recognize 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 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 medications. If you do not respond adequately or cannot tolerate these medications, Omvoh may be prescribed to reduce the signs and symptoms of ulcerative colitis, such as diarrhea, abdominal pain, urgency, and rectal bleeding.

Crohn's disease

Crohn's disease is a chronic inflammatory condition of the gastrointestinal 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 prescribed to reduce the signs and symptoms of Crohn's disease, such as diarrhea, abdominal pain, fatigue, and urgency.

2. What you need to know before starting 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 (active tuberculosis).

Warnings and precautions

• Consult your doctor or pharmacist before starting to use this medicine.
• Your doctor will check your health status before treatment.
• Make sure to inform your doctor about any medical conditions you have before 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 any symptoms of infection, such as:

• Also inform your doctor if you have recently been in close contact with someone who may have tuberculosis.
• Your doctor will examine you and perform a test to check for tuberculosis before you start using Omvoh.
• If your doctor believes you are at risk of having active tuberculosis, they may prescribe treatment for it.

Vaccines

Your doctor will check whether you need any vaccines before starting treatment. Inform your doctor, pharmacist, or nurse if you have recently been vaccinated or are scheduled to receive a vaccine. Some types of vaccines (live vaccines) should not be given while you are using Omvoh.

Allergic reactions

• Omvoh may potentially cause serious allergic reactions.
• Stop using Omvoh and seek immediate medical attention if you experience any of the following symptoms of a serious allergic reaction:

Liver blood tests

Your doctor will perform a blood test before starting treatment with Omvoh and during treatment to check whether your liver is functioning normally. If the blood tests are abnormal, your doctor may interrupt treatment with Omvoh and carry out additional liver tests to determine the cause.

Children and adolescents

The use of 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 taking, have recently taken, or might need to take any other medicines.
• if you have been recently vaccinated or are planning to be vaccinated. Certain types of vaccines (live vaccines) should not be administered while you are receiving Omvoh.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or plan 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 age, you are advised to avoid becoming pregnant and to use an appropriate contraceptive method while taking Omvoh and for at least 10 weeks after the last dose of Omvoh.

If you are breastfeeding or planning to breastfeed, consult 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 (main component of table/cooking salt) in each 300 mg dose for the treatment of ulcerative colitis. This corresponds to 3% of the maximum daily intake of sodium recommended for an adult.

This medicine contains 180 mg of sodium (main component of table/cooking salt) in each 900 mg dose for the treatment of Crohn's disease. This corresponds to 9% of the maximum daily intake of sodium recommended for an adult.

Before Omvoh is administered to you, it is mixed with a solution that may contain sodium. Consult 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 for the induction dose to treat ulcerative colitis and equivalent to 22.5 mg for the induction dose to treat Crohn's disease. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How Omvoh is used

Omvoh should be used under the guidance and supervision of a physician experienced in the diagnosis and treatment of ulcerative colitis and Crohn's disease.

What dose of Omvoh is given and for how long

Your doctor will decide the dose of Omvoh you need and the duration of treatment. Omvoh is intended for long-term treatment. Your doctor or nurse will periodically monitor your condition to ensure the treatment is having the desired effect.

Ulcerative colitis

• Induction treatment: the first dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (a drip into a vein in the arm) over 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 you do not have an adequate therapeutic response after these 3 infusions, your doctor may consider continuing with intravenous infusions at weeks 12, 16, and 20.

• Maintenance treatment: 4 weeks after the last intravenous infusion, a maintenance dose of 200 mg of Omvoh will be administered by subcutaneous injection ("under the skin") and then every 4 weeks thereafter. The 200 mg maintenance dose will be given either as two 100 mg subcutaneous injections of Omvoh or as one 200 mg subcutaneous injection 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 infusions.

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

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

Crohn's disease

• Induction treatment: the first dose of Omvoh is 900 mg (3 vials containing 300 mg each), administered by your doctor as an intravenous infusion (a drip into a vein in the arm) over 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 treatment: 4 weeks after the last intravenous infusion, a maintenance dose of 300 mg of Omvoh will be administered by subcutaneous injection ("under the skin") and then every 4 weeks thereafter. The 300 mg maintenance dose will be administered using one 100 mg pre-filled syringe or pen and one 200 mg pre-filled syringe or pen. The injections may be given in any order.

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

During maintenance treatment, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving training in the subcutaneous injection technique. It is important that you do not attempt to self-inject until your doctor or nurse has trained you. 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

If you miss a dose of Omvoh, consult your doctor.

If you stop using Omvoh

You must not stop treatment with Omvoh without first consulting your doctor. If you stop treatment, your disease symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience 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
• Allergic reaction related to infusion (e.g.: itching, urticaria)
• Increased levels of liver enzymes in blood

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 of the vial and on the outer packaging, following "EXP". The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the vial in the outer packaging to protect it from light.

Do not use this medicine if the vial is damaged, or if the solution appears cloudy, distinctly brown, or contains particles.

This medicine is for single use only.

Medicines should not be disposed of via wastewater. Ask your doctor, nurse, or pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

Diluted solution

It is recommended to start the infusion immediately after dilution. If not used immediately, the diluted solution prepared with sodium chloride 9 mg/mL (0.9%) injection solution may be stored refrigerated (between 2 °C and 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) 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 above 25 °C, from the time of vial puncture.

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions of the reconstituted product are the responsibility of the user and should generally not exceed 24 hours at a temperature of 2 °C to 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

Do not dilute the infusion solution with other solutions, nor administer concomitantly through the same infusion line with other electrolytes or medicines.

Keep the diluted solution away from heat or direct light.

Do not freeze the diluted solution.

6. Contents of the container and other information

Composition of Omvoh

• 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); citric acid, anhydrous (E 330); sodium chloride; polysorbate 80 (E 433); water for injections.

Nature of the product and contents of the container

Omvoh is a solution in a clear glass vial. Its colour may vary from colourless to slightly yellow.

Pack sizes of 1 vial and 3 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands

Manufacturer responsible for batch release

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).

Omvoh 300 mg concentrate for solution for infusion

mirikizumab

This information is intended for healthcare professionals only:

Omvoh must not be used if it has been frozen.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly recorded.

Dilution prior to intravenous infusion

1. Each vial is for single use only.
2. Prepare the infusion solution using an aseptic technique to ensure sterility of the prepared solution.
3. Inspect the vial contents. 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 indicated for each condition.

Ulcerative colitis: one 15 ml vial (300 mg)

Withdraw 15 ml from the mirikizumab vial (300 mg) using a suitable needle (a gauge of 18 to 21 G is recommended) and transfer to the infusion bag. When administered for the treatment of ulcerative colitis, the concentrate must be diluted only in infusion bags (bag size ranging from 50–250 ml) containing either 9 mg/ml (0.9%) sodium chloride injection solution or 5% glucose injection solution. The final concentration after dilution is 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 total) and transfer to the infusion bag, using a syringe and a suitable needle (a gauge of 18 to 21 G is recommended). When administered for Crohn's disease, the concentrate must be diluted only in infusion bags (bag size ranging from 100–250 ml) containing either 9 mg/ml (0.9%) sodium chloride injection solution or 5% glucose injection solution.

The final concentration after dilution is 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) should be connected to the prepared intravenous bag and the line should be primed.

For ulcerative colitis, the infusion should be administered over at least 30 minutes.

For Crohn's disease, the infusion should be administered over at least 90 minutes.

1. At the end of the infusion, to ensure complete dose administration, the infusion line should be flushed with 9 mg/ml (0.9%) sodium chloride solution or 5% glucose injection solution. The flush should be administered at the same rate used for Omvoh administration. The time required to flush Omvoh solution from the infusion line is in addition to the minimum infusion time of 30 minutes (ulcerative colitis) or 90 minutes (Crohn's disease).