Mirikizumab-mrkz (Intravenous, Subcutaneous)

Mirikizumab-mrkz injection is used to treat moderate to severe active ulcerative colitis.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. You may need blood tests to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you experience a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Your body's ability to fight infections may be weakened while you are being treated with mirikizumab-mrkz. It is crucial that you contact your doctor at the first signs of any infection. Check with your doctor immediately if you have any of the following symptoms while using this medicine: fever, chills, cough or hoarseness, flu-like symptoms, lower back or side pain, painful or difficult urination, or unusual tiredness or weakness.

You will need a skin test for tuberculosis before starting this medicine. Inform your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or has been exposed to tuberculosis.

Contact your doctor immediately if you experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

While being treated with mirikizumab-mrkz and after stopping treatment, do not receive any immunizations (vaccines) without your doctor's approval. Mirikizumab-mrkz may lower your body's resistance, and the vaccine may not work as effectively, or you may get the infection the vaccine is meant to prevent. Additionally, avoid being around anyone in your household who received live virus vaccines, as there is a risk they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not spend extended time in the same room with them. If you have questions about this, talk to your doctor.

In deciding to use a medicine, you must consider the risks of taking it compared to the benefits it can provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done to understand how age affects the use of mirikizumab-mrkz injection in children. Safety and effectiveness have not been proven.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of mirikizumab-mrkz injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are significant and are not an exhaustive list.

Using this medicine with any of the following medicines is usually not recommended but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken near the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Infection, active—Use is not recommended in patients with this condition.

• Tuberculosis, inactive—Should be treated first before receiving this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain
• chills
• cough
• diarrhea
• ear congestion
• fever
• headache
• loss of taste or smell
• loss of voice
• muscle pain
• nausea or vomiting
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness

Less common

• Burning or stinging of the skin
• painful blisters on the trunk of body
• painful cold sores or blisters on the lips, nose, eyes, or genitals

Incidence not known

• Chest tightness
• dark urine
• difficulty swallowing
• fast heartbeat
• hives, itching, skin rash
• loss of appetite
• lower back or side pain
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stomach pain, severe
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common

• Difficulty in moving
• joint pain
• muscle pain or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Omvoh

Available Dosage Forms:

• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Mirikizumab

Find detailed information on biosimilars for this medication.

This medicine is available in 2 forms: vial and prefilled pen.

Vial: A nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV that is placed in one of your veins. It must be given slowly, so the IV catheter will have to remain in place for at least 30 minutes.

Prefilled pen: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not inject into skin areas that are red, bruised, tender, or hard.

To use the prefilled pen:

• Wash your hands with soap and water before and after using this medicine.
• Allow 30 minutes for the pens to warm up to room temperature. Do not use other heat sources (eg, microwave, hot water, direct sunlight).
• Check the liquid in the pen. It should be colorless to slightly yellow to slightly brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is damaged. Do not shake.
• Remove the cap. Make sure the pen is locked. Leave the gray base cap on until you are ready to inject.
• Twist of the gray base cap and throw it away. Do not put the cap back on. This could damage the needle. Do not touch the needle.
• Place and hold the clear base flat and firmly against the skin. Keep the clear base on the skin, then turn the lock ring to the unlock position.
• Press and hold the blue injection button for 10 seconds. You will hear a loud click. Keep holding the clear base firmly against the skin. You will hear a second loud click in about 10 seconds after the first one.
• Once complete, you will see the gray plunger. Remove the pen from the skin.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen):For ulcerative colitis: Adults—The first 3 doses are given by a doctor through an IV catheter placed in one of your veins at Week 0, Week 4, and Week 8. Then starting at Week 12, you may receive 200 milligrams (mg) injected under your skin every 4 weeks. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If needed, the prefilled pen can be stored at room temperature for up to 2 weeks. Do not return to the refrigerator.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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