Omvoh

XPIL (Text-only Patient Information Leaflet)

Source: Omvoh_300mg_PIL_Feb25_OM020_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® 300 mg concentrate for solution for infusion

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.

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Contents of this leaflet:

1. What Omvoh is and what it is used for

2. What you need to know before you receive Omvoh

3. How Omvoh is used

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 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 recognise and bind specifically to certain target proteins in the body. Omvoh works by attaching to and blocking a protein 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 bowel. 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 signs and symptoms such as diarrhoea, abdominal pain, urgency and rectal bleeding.

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 such as diarrhoea, abdominal pain, fatigue and urgency.

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2. What you need to know before you receive Omvoh

Do not use Omvoh:

- if you are allergic to mirikizumab or any of the other ingredients (see section 6).

- if you have important active infections (e.g. tuberculosis).

Warnings and precautions

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

- Your doctor will check how well you are before treatment.

- Make sure you tell your doctor about any illness you have before treatment.

Infections

- Omvoh can potentially cause serious infections.

- Do not start treatment if you have an active infection until it is gone.

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

 * fever, chills, muscle aches, cough, sore throat, runny nose, shortness of breath, pain when urinating.

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

- Your doctor may test you for tuberculosis before Omvoh.

- If you are at risk, you may be given medicines to prevent it.

Vaccinations

Tell your doctor if you recently had or plan to have a vaccine. Some types of vaccines (live vaccines) should not be given while using Omvoh.

Allergic reactions

Stop using Omvoh and get emergency help if you develop:

- rash, hives, dizziness, fainting

- low blood pressure

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

- trouble breathing

- throat or chest tightness

Liver blood test

Your doctor will check your liver before and during treatment. If results are abnormal, treatment may be interrupted.

Children and adolescents

Omvoh is not recommended under 18 years of age.

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3. How Omvoh is used

Omvoh is given under supervision of a doctor experienced in treating ulcerative colitis or Crohn’s disease.

Ulcerative colitis

- Starting dose: 300 mg by intravenous infusion (over at least 30 minutes). Two further doses at 4-week intervals.

- Maintenance: 200 mg by subcutaneous injection every 4 weeks (2 x 100 mg injections).  

- If response is lost, further IV infusions may be given.  

- You may be trained to inject yourself for maintenance.

Crohn’s disease

- Starting dose: 900 mg by intravenous infusion (over at least 90 minutes). Two further doses at 4-week intervals.

- Maintenance: 300 mg by subcutaneous injection every 4 weeks (1 x 100 mg + 1 x 200 mg injection).  

- The 200 mg strength is for Crohn’s disease only.  

- You may be trained to inject yourself for maintenance.

If you receive more Omvoh than you should

Tell your doctor.

If you forget a dose

Tell your doctor.

If you stop using Omvoh

Do not stop without your doctor’s advice. Your 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 (more than 1 in 10 people):

- injection site reactions (red skin, pain)

Common (up to 1 in 10 people):

- upper respiratory tract infections

- joint pain

- headache

- rash

Uncommon (up to 1 in 100 people):

- shingles

- infusion-related allergic reaction (itch, hives)

- raised liver enzymes

Reporting of side effects

Report to your doctor, pharmacist, or directly 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 the sight and reach of children.

- Do not use after expiry date (last day of month on vial/carton).

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

- Keep in outer carton to protect from light.

- Do not use if cloudy, brown, damaged or with particles.

- For single use only.

- Dispose of properly; do not throw in wastewater.

Diluted solution:

- Sodium chloride 0.9%: store up to 96h refrigerated, or up to 10h at room temperature (≤25°C).

- Glucose 5%: use within 48h, with max 5h at room temperature.

- Protect from heat and light. Do not freeze.

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6. Contents of the pack and other information

What Omvoh contains

- Active substance: mirikizumab. Each vial: 300 mg in 15 ml (20 mg/ml).

- Other ingredients: sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride, polysorbate 80 (E433), water for injections.

What Omvoh looks like

- Solution in a clear vial, colourless to slightly yellow.

- Packs of 1 or 3 vials. Not all sizes 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 representatives

- 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.

Further information: www.ema.europa.eu

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Reference code: OM020