Omvoh

XPIL (Text-only Patient Information Leaflet)

Source: Omvoh_100mg-200mg_PIL_Feb25_OM022_IE-MT.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the patient

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

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

mirikizumab

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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.

What is in this leaflet

1. What Omvoh is and what it is used for

2. What you need to know before you use Omvoh

3. How to use Omvoh

4. Possible side effects

5. How to store Omvoh

6. Contents of the pack and other information

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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 attaching 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 well enough or cannot tolerate these medicines, you may be given Omvoh to reduce signs and symptoms of Crohn’s disease such as diarrhoea, abdominal pain, fatigue and urgency.

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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 have important active infections (e.g., active tuberculosis).

Warnings and precautions

- Talk to your doctor or pharmacist before using this medicine.

- Your doctor will check your health before treatment.

- Tell your doctor about any illness you have before treatment.

Infections

- Omvoh can cause serious infections. Treatment should not be started if you have an active infection until it is gone.

- After starting treatment, tell your doctor right away if you have any symptoms of an infection, such as:

 - fever, chills, muscle aches

 - cough, shortness of breath, runny nose, sore throat

 - pain during urination

- Tell your doctor if you have recently been near anyone who might have tuberculosis.

- Your doctor may test you for tuberculosis before treatment and may prescribe medicine if you are at risk.

Vaccinations

- Your doctor will check your vaccination status before starting Omvoh.

- Do not receive live vaccines while using Omvoh.

Allergic reactions

- Omvoh can cause serious allergic reactions.

- Stop using Omvoh and get emergency medical help if you develop:

 - rash, hives, itch

 - swelling of the face, lips, mouth, tongue or throat

 - fainting, dizziness, low blood pressure

 - difficulty breathing, chest tightness, sensation of throat tightening

Liver blood test

Your doctor will perform blood tests before and during treatment to check liver function. If abnormal, treatment may be paused and further tests done.

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3. How to use Omvoh

Always use this medicine exactly as your doctor or nurse has told you. Check with them if you are not sure.

How much Omvoh is given and for how long

Your doctor will decide your dose and treatment duration. Omvoh is for long-term treatment. Your doctor or nurse will regularly monitor your condition.

Crohn’s disease

- Treatment start: The first dose is 900 mg (3 vials of 300 mg each) given by intravenous infusion over at least 90 minutes. A second and third 900 mg dose are given 4 weeks apart.

- Maintenance therapy: Four weeks after the last infusion, a maintenance dose of 300 mg is given every 4 weeks by subcutaneous injection. This requires 2 injections (100 mg + 200 mg pens).

The 200 mg pre-filled pen is only for Crohn’s disease.

Switch to subcutaneous injection will be decided by your doctor. You may inject yourself after proper training. A caregiver may also inject after training.

If you use more Omvoh than you should

Tell your doctor immediately.

If you forget to use Omvoh

Inject as soon as possible, then continue every 4 weeks.

If you stop using Omvoh

Do not stop without speaking to your doctor, as symptoms may return.

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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., redness, pain)

Common (may affect up to 1 in 10 people)

- Upper respiratory tract infections (nose/throat)

- Joint pain

- Headache

- Rash

Uncommon (may affect up to 1 in 100 people)

- Shingles

- Infusion-related allergic reaction (e.g., itch, hives)

- Increased liver enzymes

Reporting of side effects

Talk to your doctor, pharmacist or nurse. You can also report side effects via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- Malta: ADR Reporting (www.medicinesauthority.gov.mt/adrportal)

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5. How to store Omvoh

- Keep out of sight and reach of children.

- Do not use after the expiry date (EXP, last day of month).

- Store in refrigerator (2–8 °C). Do not freeze.

- Do not microwave, run under hot water, or expose to direct sunlight.

- Do not shake pens.

- Store in original packaging to protect from light.

- May be stored unrefrigerated for up to 2 weeks at ≤30 °C, then discard.

- Do not use if pen is damaged, cloudy, brown or contains particles.

- For single use only.

- Do not dispose via wastewater or household waste. Ask your doctor, nurse or pharmacist how to dispose.

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6. Contents of the pack and other information

What Omvoh contains

- Active substance: mirikizumab

 - One pen contains 100 mg in 1 mL solution.

 - One pen contains 200 mg in 2 mL solution.

- Other ingredients: histidine, histidine monohydrochloride, sodium chloride, mannitol (E421), polysorbate 80 (E433), water for injections.

What Omvoh looks like

- Clear to slightly yellow solution in a disposable pre-filled pen.

- Packs of 2 pens, or multipacks of 3 cartons (each with 2 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

Local contacts

- Ireland: Eli Lilly and Company (Ireland) Limited. Tel: +353 (0)1 661 4377

- Malta: Charles de Giorgio Ltd. Tel: +356 25600 500

This leaflet was last revised in February 2025.

Other sources of information

Detailed information is available at: www.ema.europa.eu

Code: OM022