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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

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

mirikizumab

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

Read the entire 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult 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 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 identify 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 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 given 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 components 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

• Consult your doctor or pharmacist before starting to use this medicine.
• Your doctor will assess your condition before starting 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 had 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 medications to treat 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 be vaccinated. 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 carry out a blood test before starting treatment with Omvoh and during treatment to check whether your liver is functioning normally. If the blood test results are abnormal, your doctor may interrupt treatment with Omvoh and carry out additional tests on your liver 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 recently been vaccinated or are due to be vaccinated. Certain types of vaccines (live vaccines) must not be administered while using 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 plan 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 use machines.

Omvoh contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.

Omvoh contains polysorbate

This medicine contains 0.3 mg/ml of polysorbate 80 in each pen, equivalent to 0.9 mg for the maintenance dose used to treat Crohn's disease. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Omvoh

Follow exactly the instructions for administering this medicine as given by your doctor or nurse. If in doubt, consult your doctor, nurse, or pharmacist again.

How much Omvoh is administered and for how long

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

Crohn’s disease

• Induction treatment: the first dose of Omvoh is 900 mg (3 vials of 300 mg each), which your doctor will administer by intravenous infusion (a drip into a vein in your 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 given as 2 injections: one containing 100 mg (1 ml) of Omvoh and another 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 treatment, you and your doctor or nurse should decide whether you should self-inject Omvoh after receiving training in 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. A caregiver may also administer the Omvoh injection after appropriate training.

Use a reminder method, such as notes on a calendar or diary, to help you remember when to administer your next dose to avoid missing or repeating a dose.

If you receive more Omvoh than you should

If you have received more Omvoh than you should, or if the dose was administered earlier than prescribed, 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. After that, resume administration every 4 weeks.

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 everyone 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, hives)
• 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 may also report them directly through the national reporting system included 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 and 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.

Do not heat the pens in the microwave, do not immerse them in hot water, or expose them to direct sunlight.

Do not shake the pre-filled pen.

Store 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 pen is damaged, or if the solution is cloudy, noticeably 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 you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omvoh

• The active substance is mirikizumab.

A pre-filled pen contains 100 mg of mirikizumab in 1 ml of solution and a 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.

Appearance of the product and contents of the pack

Omvoh is a solution in a clear glass cartridge inserted into a disposable pen for single use. Its colour may vary from colourless to slightly yellow.

Omvoh is available in packs containing 2 pre-filled pens and in multiple packs of 3 cartons, each containing 2 pre-filled pens.

Only some 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 about this medicinal product, please contact 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 Health Products (AEMPS) (https://www.aemps.gob.es/).

Instructions for use

Omvoh 100 mg injectable solution in pre-filled pen

Omvoh 200 mg injectable solution in pre-filled pen

mirikizumab

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

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

Also note:

• Your healthcare professional must show you how to prepare and inject Omvoh using the pen. Do not inject yourself or inject another person until you have been shown how to inject Omvoh.
• Each Omvoh pen is for single use only. Do not share or reuse your pen. This could transmit or result in transmission of infection.
• Your healthcare professional can help you decide which area of your body to inject your dose. You can also read the section "Choose your injection site" in these instructions to help you select the best area for you.
• If you have vision or hearing problems, do not use the Omvoh pen without help from a caregiver.
• Keep these instructions for use and review them again whenever needed.

Before using Omvoh pens, carefully read and follow all step-by-step instructions.

2 pens = complete dose of 300 mg

After your first injection, select a new injection site at least 5 centimeters away and clean it.

With your second pen**, repeat steps 1–3** immediately after your first injection.

You must inject 2 pens to complete your full dose of 300 mg

Parts of the Omvoh pen

Inject both pens in any order to achieve a complete dose of 300 mg. The 200 mg pen is larger than the 100 mg pen.

Preparing to inject Omvoh

Inject Omvoh

Remove the feathers from Omvoh

• If you do not have a sharps disposal container, you may use a household container that is:

• made of heavy-duty plastic,

• has a tightly secured, puncture-resistant lid that prevents sharp objects from coming out,

• upright and stable during use,

• leak-resistant,

• properly labeled to warn of the presence of hazardous waste inside the container.

• When your sharps disposal container is almost full, follow your community's guidelines for proper disposal. There may be local regulations regarding the disposal of needles and pens.

• Do not recycle your used sharps disposal container.

• For more information on proper disposal of the container, ask your healthcare professional about available options in your area.

Frequently Asked Questions

• What if I let my pens warm up for more than 45 minutes before injection?

• Your pen may remain at room temperature up to 30 °C for up to 2 weeks.

• What if I see air bubbles in the pen?

• It is normal to have air bubbles in the pen. They will not harm you or affect your dose.

• What if there is a drop of liquid at the needle tip when I remove the grey base cap?

• A drop of liquid at the needle tip is normal. It will not harm you or affect your dose.

• What if I unlock the pen and press the blue injection button until the injection is complete?

• Do not remove the grey base cap. Do not use the pen. Consult your doctor or pharmacist for a replacement.

• Do I need to keep pressing the blue injection button until the injection is complete?

• It is not necessary to keep pressing the blue injection button, but doing so may help keep the pen stable and steady against your skin.

• What if the needle does not retract after my injection?

• Do not touch the needle or replace the grey base cap. Store the pen in a safe place to avoid accidental needlesticks and contact your doctor, pharmacist, or nurse.

• What if there is a drop of liquid or blood on my skin after the injection?

• This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

• What if I heard more than 2 clicks during my injection—2 loud clicks and one soft click? Did I receive my full injection?

• Some patients may hear a soft click just before the second loud click. This is the pen's normal function. Do not remove the pen from your skin until you hear the second loud click.

• How can I tell if my injection is complete?

• After pressing the blue injection button, you will hear 2 loud clicks. The second loud click indicates that your injection is complete. You will also see the grey plunger at the top of the transparent base.

To learn more about your medicine, read the full Omvoh package leaflet inside this package.

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