Mirikizumab-mrkz (mir-i-KIZ-ue-mab - mrkz)

Treats ulcerative colitis.

Brand Name(s):

Omvoh, Omvoh Pen, Omvoh Prefilled Syringe

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed into a vein or as a shot under your skin of your stomach, thigh, or upper arm.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, or hard.
• This medicine is available in 2 forms: vial and prefilled pen.
• 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 (including 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 cao 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.
• Use a new needle and syringe each time you inject your medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease or tuberculosis. Tell your doctor if you have any type of infection or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk of infection
  • Liver problems
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning or stinging of the skin, painful blisters on the trunk of body
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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