Prospect: information for the patient

Omvoh 100 mg injectable solution in preloaded pen

mirikizumab

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Omvoh contains the active ingredient mirikizumab, a monoclonal antibody. Monoclonal antibodies are proteins that specifically identify and bind to certain proteins in the body. Omvoh acts 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 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 sufficiently well or cannot tolerate these medications, you may be given Omvoh to reduce the signs and symptoms of ulcerative colitis, such as diarrhea, abdominal pain, tenesmus, and rectal bleeding.

Do not use Omvoh

• If you are allergic to mirikizumab or any of the other components of this medication (listed in section 6). If you think you may be allergic, consult your doctor before using Omvoh.
• If you have active important infections (active tuberculosis).

Warnings and precautions

• Consult your doctor or pharmacist before starting to use this medication.
• Your doctor will check how you are before starting treatment.
• Make sure to inform your doctor about any illness you suffer from before treatment.

Infections

• Omvoh may potentially cause serious infections. Do not start treatment with Omvoh if you have an active infection until the infection has cleared up.
• After starting treatment, inform your doctor immediately if you have any symptoms of infection, such as:

• Also inform your doctor if you have recently been near someone who may have tuberculosis.
• Your doctor will examine you and perform a test for tuberculosis detection before using Omvoh.
• If your doctor thinks you are at risk of developing active tuberculosis, they may administer medication to treat it.

Vaccines

Your doctor will check if you need any vaccinations before starting treatment. Inform your doctor, pharmacist, or nurse if you have recently been vaccinated or are going to be vaccinated. Certain types of vaccines (live vaccines) should not be administered while using Omvoh.

Allergic reactions

• Omvoh may potentially cause severe allergic reactions.
• Stop using Omvoh and seek medical attention immediately 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 if your liver is functioning normally. If the blood tests are abnormal, your doctor may interrupt treatment with Omvoh and perform additional liver tests 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 medications and Omvoh

Inform your doctor, pharmacist, or nurse

• If you are using, have used recently, or may need to use any other medication.
• If you have recently been vaccinated or are going to be vaccinated. Certain types of vaccines (live vaccines) should not be administered while using Omvoh.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication. It is preferable to avoid using Omvoh during pregnancy. The effects of Omvoh on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive method while using Omvoh and for at least 10 weeks after the last dose of Omvoh.

If you are breastfeeding, or intend to be, consult your doctor before using this medication.

Driving and operating machinery

It is unlikely that Omvoh will affect your ability to drive and operate machinery.

Omvoh contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or nurse. In case of doubt, consult your doctor, nurse, or pharmacist again.

How much Omvoh is administered and for how long

Your doctor will decide the amount of Omvoh you need and the duration of treatment. Omvoh is for long-term treatment. Your doctor or nurse will monitor your condition periodically to check that the treatment is having the desired effect.

• Start of treatment: the first dose of Omvoh is 300 mg and your doctor will administer it through intravenous infusion (drip in a vein in the arm) for at least 30 minutes.

After the first dose, you will receive another dose of 300 mg 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 through subcutaneous injection and then, every 4 weeks. The maintenance dose of 200 mg will be administered through 2 subcutaneous injections of 100 mg of Omvoh each.

If you lose the response after receiving the maintenance dose of Omvoh, your doctor may decide to administer 3 doses of Omvoh through intravenous infusions.

Your doctor or nurse will indicate when to switch to subcutaneous injections.

During maintenance treatment, you and your doctor or nurse must decide whether you should inject Omvoh yourself after receiving training in the subcutaneous injection technique. It is essential that you do not attempt to inject yourself until your doctor or nurse have taught you. Your doctor or nurse will provide the necessary training. A caregiver can also administer the Omvoh injection after proper training.

Use a reminder method, such as notes in a calendar or diary, to help you remember when to administer your next dose to avoid missing or repeating the dose.

If you receive more Omvoh than you should

If you have received more Omvoh than you should or the dose was administered before the prescribed time, inform your doctor.

If you forgot to use Omvoh

If you forgot to inject a dose of Omvoh, inject it as soon as possible. From then on, resume administration every 4 weeks.

If you interrupt treatment with Omvoh

You should not interrupt treatment with Omvoh without consulting your doctor first. If you interrupt treatment, the symptoms of ulcerative colitis may reappear.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Frequent(may affect up to 1 in 10 people):

• Upper respiratory tract infections (nose and throat infections)
• Joint pain
• Headache
• Skin rash
• Reactions at the injection site (e.g.: skin redness, pain)

Less Frequent(may affect up to 1 in 100 people):

• Herpes
• Allergic reaction related to perfusion (e.g.: itching, urticaria)
• Increased level of liver enzymes in the blood.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and on the outer packaging after “CAD”. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C). Do not freeze.

Do notheat the plume in the microwave, do not soak it with warm water, or expose it to direct sunlight.

Do notshake the preloaded plume.

Store in the original packaging to protect it from light.

Omvoh can be stored without refrigeration for up to 2 weeks at a temperature not exceeding 30 °C.

If these conditions are exceeded, Omvoh should be discarded.

Do not use this medication if you observe that the preloaded plume is damaged, or the medication is cloudy, significantly brown, or has particles.

This medication is for single use only.

Medications should not be disposed of through drains. Ask your doctor, nurse, or pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Omvoh

• The active ingredient is mirikizumab.

Each pre-filled syringe contains 100 mg of mirikizumab in 1 ml of solution.

• The other components are sodium citrate dihydrate; anhydrous citric acid; sodium chloride; polisorbate 80; and water for injection.

Appearance of the product and contents of the pack

Omvoh is a solution in a transparent glass cartridge inserted in a disposable pen for single use. Its color may vary from colorless to slightly yellow.

Pack sizes of 2, 4 or 6 pre-filled syringes. Only some pack sizes may be marketed.

Marketing Authorization Holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83

3528 BJ Utrecht

Netherlands

Responsible Person

Lilly France S.A.S.

Rue du Colonel Lilly

67640 Fegersheim

France

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Last update of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

Instructions for use

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

mirikizumab

2 pre-filled pens

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

Also note:

• Your healthcare professional should 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.
• Each pen of Omvoh is for single use only. Do not share or re-use your pen. You may transmit or be transmitted an infection.
• Your healthcare professional may help you decide where to inject your dose. They may also read these instructions for the section “Choose your injection site” to help you choose which area may be best for you.
• If you have vision or hearing problems, do not use the Omvoh pen without the help of a caregiver.
• Keep the instructions for use and refer to them if you need to.

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

Parts of the Omvoh pen

Upper part

Lower part

100 mg/ml + 100 mg/ml = 1 complete dose

Preparing to inject Omvoh

Injecting Omvoh

Dispose of used pens

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

• made of plastic that is puncture-resistant,
• can be closed with a tight-fitting lid, resistant to puncture, without objects that can cause cuts,
• vertical and stable during use,
• resistant to leaks,
• properly labeled to warn of the presence of hazardous waste inside the container.

When your sharps container is almost full, you should follow the guidelines of your community on how to dispose of it correctly. There may be local regulations on how to dispose of needles and syringes.

Do not recycle your used sharps container.

For more information on how to dispose of the container correctly, ask your healthcare professional about the options available in your area.

Frequently Asked Questions

Q. What happens if I let my pens warm up for more than 30 minutes before injection?

A.Your pen may remain at room temperature up to 30°C for a maximum of 2 weeks.

Q. What happens if I see air bubbles in the pen?

A.It is normal to see air bubbles in the pen. They will not harm you or affect your dose.

Q. What happens if there is a drop of liquid at the tip of the needle when I remove the grey cap from the base?

A.A drop of liquid at the tip of the needle is normal. It will not harm you or affect your dose.

Q. What happens if I unlock the pen and press the blue injection button until the injection is complete?

A.Do not remove the grey cap from the base. Do not use the pen. Consult your doctor or pharmacist for a new one.

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

A.No, you do not need to keep the blue injection button pressed, but it may help you keep the pen stable and firmly on your skin.

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

A.Do not touch the needle or put the grey cap back on the base. Keep the pen in a safe place to avoid accidental puncture and contact your doctor, pharmacist, or nurse.

Q. What happens if there is a drop of liquid or blood on my skin after the injection?

A.This is normal. Press a cotton ball or gauze over the injection site.Do not rub the injection site.

Q. What happens if I hear more than 2 clicks during my injection – 2 loud clicks and one soft click? Have I received my complete dose?

A.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.

Q. How can I know if my injection is complete?

A.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 in the upper part of the transparent base.

To know more about your medicine, read the complete leaflet of Omvoh inside this pack.

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