Patient leaflet - Omvoh 100 mg solution for injection in Pre-filled syringe
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 ulcerative colitis.
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 of ulcerative colitis such as diarrhoea, 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, ask your doctor for advice before using Omvoh.
- If you have important active infections (active 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. Treatment with Omvoh should not be started if you have an active infection until the infection is gone.
After starting the treatment, tell your doctor right away if you have any symptoms of an infection such as:
- fever o shortness of breath
- chills o runny nose
- muscle aches o sore throat
- cough o pain during urination
- Also tell your doctor if you have recently been near anyone who might have tuberculosis.
- Your doctor will examine you and may do a test for tuberculosis before you have Omvoh.
- If your doctor thinks you are at risk of an active tuberculosis, you may be given medicines to treat it.
Vaccinations
Your doctor will check to see if you need any vaccinations before starting treatment. Tell your doctor, pharmacist or nurse if you have recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Omvoh.
Allergic reactions
- Omvoh can potentially cause serious allergic reactions.
Stop using Omvoh and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- rash o low blood pressure
- fainting o swelling of the face, lips, mouth, tongue or throat, trouble breathing
- dizziness o sensation of throat tightening or chest tightness.
Liver blood test
Your doctor will conduct blood tests before starting and during treatment with Omvoh to check if your liver is functioning normally. If blood tests are abnormal, your doctor might interrupt therapy with Omvoh and do additional tests on your liver to determine the cause.
Children and adolescents
Omvoh is not recommended for children and adolescents under 18 years of age because 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 recently had or are going to have a vaccination. Some types of vaccines (live vaccines) should not be given while using Omvoh.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. It is preferable to avoid the use of Omvoh in pregnancy. The effects of Omvoh in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and should use effective contraception while using Omvoh and for at least 10 weeks after the last Omvoh dose.
If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Driving and using machines
Omvoh is unlikely to influence your ability to drive and use machines.
Omvoh contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium -free”.
Omvoh contains polysorbate
This medicine contains 0.3 mg/mL of polysorbate 80 in each syringe which is 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 allergies.
3. How to use Omvoh
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure how to use this medicine.
How much Omvoh is given and for how long
Your doctor will decide how much Omvoh you need and for how long. Omvoh is for long-term treatment. Your doctor or nurse will regularly monitor your condition to check that the treatment is having the desired effect.
Ulcerative colitis
Treatment start: The first dose of Omvoh is 300 mg and will be given by your doctor by intravenous infusion (drip in a vein in your arm) over at least 30 minutes. After the first dose, you will receive another dose of Omvoh 300 mg 4 weeks later and again after an additional 4 weeks.
If you do not have adequate therapeutic response after these 3 infusions, your doctor might consider continuing intravenous infusions at weeks 12, 16 and 20.
Maintenance therapy: 4 weeks after the last intravenous infusion, a maintenance dose of Omvoh 200 mg will be given by an injection under the skin (‘subcutaneously’) and then every 4 weeks. The maintenance dose of 200 mg will be given by using 2 injections each containing 100 mg of Omvoh.
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 therapy you and your doctor or nurse should decide if you should inject Omvoh yourself after training in subcutaneous injection technique. It is important not to try to inject yourself until you have been trained by your doctor or nurse. Your doctor or nurse will offer the necessary training.
A caregiver may also give you your Omvoh injection after proper training. Use a reminder method such as notes in a calendar or diary to help you remember when to take your next dose so that you avoid missing or repeating doses.
If you receive more Omvoh than you should
If you have received more Omvoh than you should or the dose has been given sooner than prescribed, inform your doctor.
If you forget to use Omvoh
If you have forgotten to inject a dose of Omvoh, inject as soon as possible. Thereafter, resume dosing every 4 weeks.
If you stop using Omvoh
You should not stop using Omvoh without speaking to your doctor first. If you stop treatment, symptoms of ulcerative colitis may come back.
If you have any further 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. red skin, pain)
Common (may affect up to 1 in 10 people):
- Upper respiratory tract infections (nose and throat infections)
- Joint pain
- Headache
- Rash
Uncommon (may affect up to 1 in 100 people):
- Shingles
- Infusion-related allergic reaction (e.g. itch, hives)
- Increase in the level of liver enzymes in your 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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Do not freeze.
Do not microwave the syringes, run hot water over them, or leave them in direct sunlight. Do not shake your pre-filled syringe.
Store in the original packaging in order to protect from light.
Omvoh may be stored unrefrigerated for up to 2 weeks at a temperature not above 30 ºC. If these conditions are exceeded, Omvoh must be discarded.
Do not use this medicine if you notice that the pre-filled syringe is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.
This medicine is for single use only.
Do not throw away any medicines via wastewater. Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Omvoh contains
The active substance is mirikizumab.
Each pre-filled syringe contains 100 mg of mirikizumab in 1 mL solution.
The other ingredients are histidine; histidine monohydrochloride; sodium chloride; mannitol
(E 421); polysorbate 80 (E 433); water for injections.
What Omvoh looks like and contents of the pack
Omvoh is a solution in a clear glass cartridge encased in a disposable, single-use syringe. Its colour may vary from colourless to slightly yellow.
Omvoh is available in packs containing 2 pre-filled syringes of 100 mg and in multipacks comprising 3 cartons, each containing 2 pre-filled syringes of 100 mg.
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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000
This leaflet was last revised in
Instructions for use
Omvoh 100 mg solution for injection in pre-filled syringe
mirikizumab
2 pre-filled syringes: 1 syringe of 100 mg and 1 syringe of 100 mg
Read this before you inject Omvoh. Follow all the step-by-step instructions.
Also keep in mind:
- Your healthcare provider should show you how to prepare and inject Omvoh using the pre-filled syringe. Do not inject yourself or someone else until you have been shown how to inject Omvoh.
- Each Omvoh pre-filled syringe is for one-time use only. Do not share or reuse your syringe. You may give or get an infection.
Your healthcare provider may help you decide where on your body to inject your dose.
You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
- If you have vision problems, do not use Omvoh pre-filled syringe without help from a caregiver.
Keep the Instructions for use and refer to them as needed.
- 2 Omvoh injections are required for a full dose to treat ulcerative colitis.
- Inject 1 Omvoh pre-filled syringe followed right away by the other Omvoh pre-filled syringe.
Before you use the Omvoh pre-filled syringes, read and carefully follow all the step-by-step instructions.
Parts of the Omvoh pre-filled syringe
100 mg + 100 mg = 1 Full dose
Top
Bottom
IMPORTANT:
- 2 injections are required for a full dose to treat ulcerative colitis.
Inject one syringe followed right away by the other syringe.
Thumb pad
Finger grips
Grey syringe plunger
Syringe body with medicine
Needle
Needle cap
Blue plunger rod
Preparing to inject Omvoh
Take the syringes from the refrigerator
Take 2 syringes from the refrigerator.
Leave the needle caps on until you are ready to inject.
Leave the syringes at room temperature for 30 minutes before injecting.
Do not microwave the syringe, run hot water over them, or leave them in direct sunlight.
Do not use the syringes if the medicine is frozen. Do not shake the syringes.
Gather supplies Supplies:
- 2 alcohol wipes
- 2 cotton balls or pieces of gauze
- 1 sharps container (see “Disposing of Omvoh syringe”)
Inspect the syringes and the medicine
Make sure you have the right medicine. The medicine inside should be clear. It may be colourless to slightly yellow.
Do not use the syringe, and dispose of as directed by your healthcare provider if:
- it looks damaged
- the medicine is cloudy, is discoloured, or has particles
- the expiry date printed on the label has passed
- the medicine is frozen
Prepare for injection
Wash your hands with soap and water before you inject Omvoh.
Choose your injection site
Your healthcare provider can help you choose the injection site that is best for you.
- You or another person may inject the medicine into your stomach area (abdomen). Do not inject within 5 centimetres of the belly button (navel).
- You or another person may inject the medicine in the front of your thighs. This area should be at least 5 centimetres above the knee and 5 centimetres below the groin.
- Another person may give you the injection in the back of your upper arm.
- Do not inject in the exact same spot every time. For example, if your first injection was in your abdomen, your second injection - to complete a full dose - could be in another spot in your abdomen.
- Do not inject into areas where the skin is tender, bruised, red or hard.
Clean the injection site with an alcohol wipe. Let the injection site dry before you inject your medicine.
Expiry date
Back of arm
Abdomen
Thigh
Blue plunger rod Injecting Omvoh
Uncap the syringe
- Leave the needle cap on until you are ready to inject.
- Pull the needle cap off and throw it away in your household waste.
- Do not put the needle cap back on. You could damage the needle or stick yourself by accident.
- Do not touch the needle.
Insert
- Gently pinch and hold a fold of skin where you will inject.
- Insert the needle at a 45 degree angle
Inject
- Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
- The grey syringe plunger should be pushed all the way to the needle end of the syringe.
- You should see the blue plunger rod show through the syringe body when the injection is complete as shown.
- Remove the needle from your skin and gently let go of your skin.
- If you have bleeding at the injection site, press a cotton ball or gauze over the injection site.
- Do not rub the injection site.
Do not put the needle cap back on the pre-filled syringe.
Grey syringe plunger
2 injections are required for a full dose. Inject one syringe immediately followed by the other syringe.
Disposing of Omvoh syringe
Throw away the used syringe
Put the used syringe in a sharps disposal
container right away after use. Do not
throw the syringe directly into your
household waste.
If you do not have a sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant,
- properly labelled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local laws about how you should throw away needles and syringes.
- Do not recycle your used sharps disposal container.
- For more information on how to dispose of the container properly, ask your healthcare provider about options available in your area.
Commonly asked questions
Q. What if I let my syringe warm up for longer than 30 minutes before injecting? A. Your syringe can stay at room temperature up to 30 °C for up to 2 weeks.
Q. What if I see air bubbles in the syringe?
A. It is normal to have air bubbles in the syringe. They will not harm you or affect your dose.
Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
A. It is okay to see a drop of liquid on the tip of the needle. This will not harm you or affect your dose.
Q. What if I cannot push in the plunger?
A. If the plunger is stuck or damaged:
- Do not continue to use the syringe
- Remove the needle from your skin
- Do not use the syringe. Talk to your doctor or pharmacist to get a new one.
Q. What if there is a drop of liquid or blood on my skin after my injection? A. This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.
Q. How can I tell if my injection is complete?
A. When your injection is complete:
- The blue plunger rod should show through the body of the syringe.
- The grey syringe plunger should be pushed all the way to the needle end of the syringe.
Read the full package leaflet for Omvoh inside this box to learn more about your medicine.
Last revised in