Prospect: information for the patient

Omvoh 300 mg concentrate for infusion solution

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 carefully 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 are not listed 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.

No 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 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 clears 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 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 old 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 60 mg of sodium (main component of table salt/for cooking) in each 300 mg dose. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult. Before Omvoh is administered to you, it is mixed with a solution that may contain sodium. Consult your doctor if you follow a low-sodium diet.

Omvoh should be used under the guidance and supervision of a doctor with experience in diagnosing and treating ulcerative colitis.

What amount of 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 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 let you know when to switch to subcutaneous injections.

During maintenance treatment, you and your doctor or nurse should decide if you should inject Omvoh yourself after receiving training in subcutaneous injection technique. It is essential that you do not attempt to inject yourself until your doctor or nurse has taught you. Your doctor or nurse will provide the necessary training.

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 forget to use Omvoh

If you forget a dose of Omvoh, consult your doctor.

If you interrupt treatment with Omvoh

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

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

Like all medications, this medication may produce adverse effects, although not all people 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)

Rare(may affect up to 1 in 100 people)

• Herpes
• Allergic reaction related to perfusion (e.g.: itching, urticaria)
• Increased level of liver enzymes in 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 not listed 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 vial label and on the outer packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Store the vial in the outer packaging to protect it from light.

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

This medication is for single use only.

Medicines should not be thrown away through drains. Ask your doctor, nurse, or pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Diluted Solution

It is recommended to start the infusion immediately after dilution. If not used immediately, the diluted solution prepared with a 9 mg/ml (0.9%) sodium chloride injectable solution can be stored refrigerated (between 2 °C and 8 °C), for no more than 96 hours or at room temperature not exceeding 25 °C for no more than 10 hours (the total time should not exceed 96 hours) from the moment the vial is punctured. The diluted infusion solution prepared with 5% glucose should be used within 48 hours, of which no more than 5 hours at a non-refrigerated temperature above 25 °C, from the moment the vial is punctured.

From a microbiological point of view, the medication should be used immediately. If not used immediately, the times and conditions for storing the reconstituted product are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 °C to 8 °C, unless the dilution was performed in controlled and validated aseptic conditions.

Keep the diluted solution away from heat or direct light.

Do not freeze the diluted solution.

Composition of Omvoh

• The active ingredient is mirikizumab.

Each vial contains 300 mg of mirikizumab in 15 ml (20 mg/ml).

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

Appearance of the product and contents of the package

Omvoh is a solution in a transparent glass vial. Its color may vary from colorless to slightly yellow.

Package size of 1 vial.

Marketing Authorization Holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83

3528 BJ Utrecht

Netherlands

Responsible for manufacturing

Lilly France S.A.S.

Rue du Colonel Lilly

67640 Fegersheim

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information about this medication 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/).

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Omvoh 300 mg concentrate for solution for infusion

mirikizumab

This information is intended solely for healthcare professionals:

Omvoh should not be used if it has been frozen.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medication must be clearly recorded.

Dilution before intravenous infusion

1. Each vial is for single use.
2. Prepare the infusion solution using an aseptic technique to ensure the sterility of the prepared solution.
3. Inspect the contents of the vial. The concentrate must be transparent, colorless to slightly yellow, and free of visible particles. Otherwise, it must be discarded.
4. Extract 15 ml from the vial of mirikizumab (300 mg) using a suitable needle size (recommended size 18 to 21 G) and transfer to the infusion bag. The concentrate should only be diluted in infusion bags (bag size ranges from 50 to 250 ml) containing a sodium chloride 9 mg/ml (0.9%) or a glucose 5% injection solution. The final concentration after dilution is approximately 1.2 mg/ml to approximately 6 mg/ml.
5. Gently invert the infusion bag to mix. Do not agitate the prepared bag.

Administration of the diluted solution

1. The intravenous administration equipment (infusion set) should be connected to the prepared infusion bag, and the line should be purged. The infusion should be administered for at least 30 minutes.
2. At the end of the infusion, to ensure that the complete dose is administered, the infusion line should be flushed with a sodium chloride 9 mg/ml (0.9%) or a glucose 5% injection solution. The flushing should be administered at the same rate as used for the administration of Omvoh. The time required to flush the Omvoh solution from the infusion line is added to the minimum 30-minute infusion time.