OMVOH 100 mg SOLUTION FOR INJECTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the Patient

Omvoh 100 mg solution for injection in pre-filled pen

mirikizumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Omvoh and what is it used for

Omvoh contains the active substance mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that identify 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 well enough or cannot tolerate these medicines, you may be given Omvoh to reduce the signs and symptoms of ulcerative colitis, such as diarrhea, abdominal pain, urgency, and rectal bleeding.

2. What you need to know before you use Omvoh

Do not use Omvoh

• if you are allergic to mirikizumab or 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 active important infections (active tuberculosis).

Warnings and precautions

• Talk to your doctor or pharmacist before you start using this medicine.
• Your doctor will check how you are before treatment.
• Make sure you tell your doctor about any illness you have before treatment.

Infections

• Omvoh may potentially cause serious infections. Do not start treatment with Omvoh if you have an active infection until the infection has gone away.
• After starting treatment, tell your doctor right away if you have any symptoms of infection, such as:

• Tell your doctor if you have recently been near someone who may have tuberculosis.
• Your doctor will examine you and do a test for tuberculosis detection before using Omvoh.
• If your doctor thinks you are at risk of getting active tuberculosis, you may be given medicines to treat it.

Vaccines

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

Allergic reactions

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

Liver blood tests

Your doctor will do a blood test before starting treatment with Omvoh and during treatment to check if your liver is working normally. If the blood tests are abnormal, your doctor may stop treatment with Omvoh and do additional tests on your liver to determine the cause.

Children and adolescents

Omvoh should not be used in children and adolescents under 18 years of age as it has not been studied in this age group.

Other medicines and Omvoh

Tell your doctor, pharmacist, or nurse

• if you are using, have recently used, or might use any other medicines.
• if you have been vaccinated recently or are going to be vaccinated. Some types of vaccines (live vaccines) should not be given while using Omvoh.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. It is recommended to avoid using Omvoh during pregnancy. The effects of Omvoh in pregnant women are not known. If you are a woman who can become pregnant, you are advised to avoid becoming pregnant and to use a suitable 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, ask your doctor for advice before taking this medicine.

Driving and using machines

Omvoh is unlikely to affect your ability to drive or use machines.

Omvoh contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

Omvoh contains polysorbate

This medicine contains 0.3 mg/ml of polysorbate 80 in each pre-filled pen, equivalent to 0.6 mg for the maintenance dose to treat ulcerative colitis. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergy.

3. How to use Omvoh

Follow exactly the instructions for administration of this medicine given by your doctor or nurse. If you are not sure, consult your doctor, nurse, or pharmacist again.

How much Omvoh to use and for how long

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

Ulcerative colitis

• Start of treatment: the first dose of Omvoh is 300 mg and your doctor will give it to you by intravenous infusion (drip into a vein in your arm) over at least 30 minutes.

After the first dose, you will receive another dose of 300 mg 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, you will receive a maintenance dose of 200 mg of Omvoh by injection under the skin ("subcutaneously") and then every 4 weeks. The 200 mg maintenance dose will be given as 2 injections of 100 mg of Omvoh each.

If you lose response after receiving the maintenance dose of Omvoh, your doctor may decide to give you 3 doses of Omvoh by intravenous infusions.

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

During maintenance treatment, you and your doctor or nurse should decide if you should inject Omvoh yourself after receiving training in the subcutaneous injection technique. It is important that you do not try to inject yourself until your doctor or nurse has taught you. Your doctor or nurse will provide the necessary training. A caregiver can also give you the injection of Omvoh after proper training.

Use a reminder method, such as notes on a calendar or diary, to help you remember when to give 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 the dose has been given before it was due, tell 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, continue with the next dose 4 weeks later.

If you stop using Omvoh

Do not stop using Omvoh without consulting your doctor first. If you stop using Omvoh, the symptoms of ulcerative colitis may come back.

If you have any other questions on the use of this medicine, ask 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):

• Injection site reactions (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
• Infusion-related allergic reaction (e.g., itching, hives)
• Increased liver enzyme levels in blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. 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. Storage of 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 outer packaging after "EXP". The expiry date is the last day of the month stated.

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

Do notheat the pre-filled pens in the microwave, do not soak them in hot water, and do not expose them to direct sunlight.

Do notshake the pre-filled pen.

Keep the pre-filled pen in the original packaging to protect it from light.

Omvoh can be stored without refrigeration for up to 2 weeks at a temperature not above 30°C.

If these conditions are exceeded, Omvoh should be discarded.

Do not use this medicine if you notice that the pre-filled pen is damaged or the medicine is cloudy, significantly brown, or has particles.

This medicine is for single use only.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor, nurse, or pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Omvoh Composition

• The active ingredient is mirikizumab.

Each pre-filled pen contains 100 mg of mirikizumab in 1 ml of solution.

• The other components are histidine; histidine hydrochloride; sodium chloride; mannitol (E 421); polysorbate 80 (E 433); water for injectable preparations.

Product Appearance and Container Contents

Omvoh is a solution in a transparent glass cartridge inserted in a disposable pen, for single use. Its color may vary from colorless to slightly yellow.

Omvoh is presented in packs containing 2 pre-filled pens, in multiple packs of 2 cartons, each 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

Netherlands

Manufacturer

Lilly France S.A.S.

Rue du Colonel Lilly

67640 Fegersheim

France

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/).

Also note:

• Your healthcare professional should teach you how to prepare and inject Omvoh using the pen. Do notinject yourself or inject another person until you have been shown how to inject Omvoh.
• Each Omvoh pen is for single use. Do not share or reuse your pen. You may transmit or be transmitted an infection.
• Your healthcare professional may help you decide which area of your body to inject your dose. You can also read in these instructions the section "Choose your injection site" to help you choose which area may be best for you.
• If you have vision or hearing problems, do not use the Omvoh pen without the help of a caregiver.
• Keep the instructions for use and re-read them if you need to.

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

Parts of the Omvoh Pen

100 mg + 100 mg = 1 complete dose

Preparation for Injecting Omvoh

Inject Omvoh

• If you do not have a sharps disposal container, you can use a household container that is:
• made of heavy-duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharp objects being able to come out,
• is upright and stable during use,
• is leak-resistant,
• is properly labeled to warn of hazardous waste inside the container.

• When your sharps disposal container is almost full, you should follow your community's guidelines for the proper disposal of the container. There may be local regulations on how to dispose of needles and pens.
• Do not recycle your used sharps disposal container.
• For more information on how to properly dispose of the container, ask your healthcare professional about the options available in your area.

Frequently Asked Questions

• What happens if I let my pens warm up for more than 30 minutes before injection?

• Your pen can remain at room temperature up to 30°C for a maximum of 2 weeks.

• What happens 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 happens if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

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

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

• Do not remove the gray base cap. Do not use the pen. Consult your doctor or pharmacist to obtain a new one.

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

• You do not need to keep the blue injection button pressed, but it can help you keep the pen stable and firm on your skin.

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

• Do not touch the needle or put the gray base cap back on. Store the pen in a safe place to avoid accidental punctures and contact your doctor, pharmacist, or nurse.

• What happens 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 happens if I heard more than 2 clicks during my injection - 2 strong clicks and one soft click? Did I receive my complete injection?

• Some patients may hear a soft click just before the second strong click. This is the normal operation of the pen. Do not remove the pen from your skin until you hear the second strong click.

• How do I know if my injection is complete?

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

To learn more about your medication, read the complete Omvoh leaflet inside this package.

Last Revision