Omvoh 200 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Omvoh 200mg injection solution in a pre-filled pen

mirikizumab

This medicine is subject to additional monitoring, which will allow quicker detection of new safety information. 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could 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 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 medications. If you do not respond adequately or cannot tolerate these medications, Omvoh may be given 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 starting to use 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 (active tuberculosis).

Warnings and precautions

• Consult your doctor or pharmacist before starting to use this medicine.
• Your doctor will assess your health status before treatment.
• Make sure to inform your doctor about any illness 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 experience any symptoms of infection, such as:

• Also inform your doctor if you have recently been in close contact with someone who might have tuberculosis.
• Your doctor will examine you and perform a test 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 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 severe 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 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

Omvoh is not recommended for use 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 given 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 potential, 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 use of 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 of sodium (23 mg) per dose; essentially, it is “sodium-free”.

Omvoh contains polysorbate

This medicine contains 0.3 mg/ml of polysorbate 80 in each pen, equivalent to 0.6 mg for the maintenance dose used to treat ulcerative colitis. 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.

What dose of Omvoh is administered 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 of treatment: the first dose of Omvoh is 300 mg, administered by your doctor as an intravenous infusion (a drip into a vein in your 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 ("subcutaneously") and then every 4 weeks thereafter. The 200 mg maintenance dose will be given as one 200 mg 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 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 receiving 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 treatment with Omvoh

You must not stop treatment with Omvoh without first consulting your doctor. If you stop treatment, symptoms of ulcerative colitis 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 experiences them.

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

• Reactions at the injection site (e.g.: redness of the skin, 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 the 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 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 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 pen in a microwave, do not soak it in hot water, and do not expose it to direct sunlight.

Do not shake the prefilled 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 prefilled pen is damaged, or if the solution is cloudy, considerably brown, or contains particles.

This medicine is for single use only.

Medicines must not be disposed of via wastewater. Ask your doctor, nurse, or pharmacist how to properly dispose of any unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omvoh

• 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.

Nature of the product and contents of the pack

Omvoh is a solution in a clear glass cartridge contained within a single-use, disposable 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 of 3 cartons, each containing 1 pre-filled pen of 200 mg.

Only some 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 more information about this medicine, please contact the local representative of the Marketing Authorisation 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.euopa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/).

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

Important information you need to know before injecting Omvoh:

• Your healthcare provider must teach 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.
• The pre-filled pen contains 1 dose of Omvoh. The Omvoh pen is for single use only. Do not share or reuse your pen. You could transmit or receive an infection.
• Your healthcare provider can help you decide which area of your body to inject your dose. You may 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 the help of a caregiver.
• Keep these instructions for use and review them again as needed.

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

Parts of the Omvoh pen

Preparing to inject Omvoh

Inject Omvoh

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

• made of heavy-duty plastic,

• can be tightly closed with a puncture-resistant lid, preventing 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 how to properly dispose of the container, ask your healthcare professional about available options in your area.

Frequently Asked Questions

• What if I let my pens temper 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?

A. No. Do not remove the grey base cap. Do not use the pen. Consult your doctor or pharmacist to obtain a new one.

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

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

Q. What if the needle does not retract after my injection?

A. Do not touch the needle or replace the grey base cap. Store the pen in a safe place to avoid accidental needle sticks 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 normal functioning of the pen. 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 complete Omvoh package leaflet inside this package.

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