Pronunciation:

mir-i-KIZ-ue-mab - mrkz

Brand Names:

• Omvoh

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Mirikizumab

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mirikizumab-mrkz injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mirikizumab-mrkz injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that the doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed 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 have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Your body's ability to fight infection may be reduced while you are being treated with mirikizumab-mkr. It is very important that you call your doctor at the first signs of any infection. Check with your doctor right away 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 to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.

Check with your doctor right away if you have 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 you are being treated with mirikizumab-mkrz and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Mirikizumab-mkrz may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance 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 stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Side Effects of 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 occur 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.