Patient leaflet - Omvoh 100 mg solution for injection in Pre-filled pen
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
○ shortness of breath
○ chills
○ runny nose
○ muscle aches
○ sore throat
○ cough
○ 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
○ low blood pressure
○ fainting
○ swelling of the face, lips, mouth, tongue or throat, trouble breathing
○ dizziness
○ 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 pen 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 pens, run hot water over them, or leave them in direct sunlight.
Do not shake your pre-filled pen.
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 pen 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 pen contains 100 mg of mirikizumab in 1 mL solution.
- The other ingredients are sodium citrate dihydrate; citric acid, anhydrous; sodium chloride; polysorbate 80; 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 pen. Its colour may vary from colourless to slightly yellow.
Pack sizes of 2, 4 or 6 pre-filled pens.
Not all pack sizes may be marketed.
Product Licence Holder and Manufacturer
Procured from within the EU by the Product Licence holder Orifarm UK Ltd., Ground Floor Suite A2, Breakspear Park, Breakspear Way, Hemel Hempstead, HP2 4TZ, UK For any information about this medicine, please contact the Product Licence Holder on www.orifarm.com/uk
Or phone: (+44) 1923 204333
Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic
Manufactured by Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegerheim, France omvoh 100 mg solution for injection pre-filled pen PL 45985/1054
POM
Leaflet revision date: 10/07/2025
Blind or partially sighted? Is this leaflet hard to see or read?
Call +45 63 95 27 00 to obtain the leaflet in a format suitable for you. Package leaflet: Information for the patient
Omvoh® 100 mg solution for injection in pre-filled pen
mirikizumab
2 injections are required for a full dose. Inject one pen immediately followed by the other pen. Instructions for use
Omvoh® 100 mg solution for injection in pre-filled pen mirikizumab
2 pre-filled pens:
1 pen 100 mg and 1 pen 100 mg
Read this before you inject Omvoh. Follow all the step-by-step instructions.
- 2 Omvoh injections are required for a full dose to treat ulcerative colitis.
Inject 1 Omvoh pen followed right away by the other
Omvoh pen.
Also keep in mind:
Your healthcare provider should show you how to prepare and inject
Omvoh using the pen. Do not inject yourself or someone else until you have been shown how to inject Omvoh.
Each Omvoh pen is for one-time use only. Do not share or reuse your
pen. 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 or hearing problems, do not use Omvoh pen without help
from a caregiver.
- Keep the Instructions for use and refer to them as needed.
INSTRUCTIONS FOR USE
Before you use the Omvoh pens, read and carefully follow all the step-by-step instructions.
Parts of the Omvoh pen
1 Full dose
100 mg 100 mg
Top
Lock ring
Blue injection button
Lock/unlock symbols
Bottom
Medicine
Needle
Clear base
Grey base cap
IMPORTANT:
- 2 injections are required for a full dose to treat ulcerative colitis.
Inject 1 pen followed right away by the other pen.
Preparing to inject Omvoh
Take the pens from the refrigerator
Take 2 Omvoh pens from the refrigerator.
Leave the grey base caps on until you are ready to inject.
Leave the pens at room temperature for 30 minutes before injecting. Do not microwave the pens, run hot water over them, or leave them in direct sunlight.
Do not use the pens if the medicine is frozen.
Do not shake.
Gather supplies Supplies:
- 2 alcohol wipes
2 cotton balls or pieces of gauze ● 1 sharps container (see “Disposing
of Omvoh pens”)
Inspect the pens and the medicine
Expiry date
Make sure you have the right medicine. The medicine inside should be clear. It may be colourless to slightly yellow.
Do not use the pens, 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
Abdomen
Back of arm
Thigh
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.
Injecting Omvoh
1 Uncap the pen
Make sure the pen is locked.
Leave the grey base cap on until you are ready to inject.
Twist off the grey base
cap and throw it away in your household waste.
Do not put the grey
base cap back on – this could damage the needle.
Do not touch the
needle.
Needle
Grey base cap
2 Place and Unlock
Place and hold the
clear base flat and firmly against your skin.
Keep the base on your skin and turn the lock ring to the unlock position.
Clear base
3 Press and Hold for up to
10 Seconds
Press and hold the
blue injection button. You will hear a loud click (injection started). ● Keep holding the
clear base firmly against your skin. You will hear a second loud click in about 10 seconds after the first one (injection completed).
You will know the
injection is complete when the grey plunger is visible.
Remove the pen from
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.
10seconds
Grey plunger
Disposing of Omvoh pens
Throw away the used pens
Put the used pen in a sharps
disposal container right away after
use. Do not throw the pen 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, punctureresistant 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 pens.
- 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 pens warm up for longer than 30 minutes before injecting?
A. Your pen can stay at room temperature up to 30 °C for up to 2 weeks.
Q. What if I see air bubbles in the pen?
A. It is normal to have air bubbles in the pen. 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 grey base 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 unlocked the pen and pressed the blue injection button down until the injection is complete?
A. Do not remove the grey base cap. Do not use the pen. Talk to your doctor or pharmacist to get a new one.
Q. Do I need to hold the blue injection button down until the injection is complete?
A. You do not need to hold the blue injection button down, but it may help you keep the pen steady and firm against your skin.
Q. What if the needle did 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 an accidental needlestick and contact your doctor, pharmacist or nurse.
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. What if I heard more than 2 clicks during my injection – 2 loud clicks and a soft one. Did I get my complete injection?
A. Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second loud click.
Q. How can I tell if my injection is complete?
A. After you press the blue injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the grey plunger at the top of the clear base.
Read the full package leaflet for Omvoh inside this box to learn more about your medicine.