What is the most important information I should know about OMVOH?
OMVOH can cause serious side effects, including:

• Serious allergic reactions. OMVOH may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Stop using OMVOH and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

  fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing

  trouble breathing, throat tightening or wheezing chest tightness

  fast heartbeat or pounding in your chest (tachycardia) severe itching, hives, or redness all over your body sweating

• Infections. OMVOH may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should not start treatment with OMVOH until your infection is gone.
  • Before starting your treatment with OMVOH, your healthcare provider should test you for tuberculosis (TB).
  • If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with OMVOH.
  • Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with OMVOH and after treatment.
  • Before starting OMVOH, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as:

    fever, sweating, or chills muscle aches and pain cough or shortness of breath blood in your mucus (phlegm)

    flu-like symptoms headache warm, red, or painful skin or sores on your body

    diarrhea or stomach pain weight loss nausea or vomiting pain during urination

  After starting OMVOH, tell your healthcare provider right away if you have any symptoms of an infection.

• Liver problems. OMVOH may cause liver problems. Your healthcare provider will do blood tests to check your liver enzyme and bilirubin levels before treatment, for at least 24 weeks during treatment, and possibly after treatment with OMVOH. Your healthcare provider may hold or stop your treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

  unexplained rash nausea vomiting stomach-area (abdominal) pain

  feeling tired loss of appetite yellowing of the skin or the whites of your eyes dark urine

• are allergic to mirikizumab-mrkz or any of the ingredients in OMVOH. See the end of this Medication Guide for a complete list of ingredients in OMVOH.

• Use OMVOH exactly as your healthcare provider tells you to.
• You will receive your first 3 doses of OMVOH through a vein in your arm (intravenous infusion) in a healthcare facility by a healthcare provider every 4 weeks.
  • For ulcerative colitis, each infusion will last about 30 minutes.
  • For Crohn's disease, each infusion will last about 90 minutes.
• After your intravenous infusions, you will continue to receive OMVOH as an injection under the skin (subcutaneous injection) every 4 weeks as described below.
• See the detailed Instructions for Use that comes with OMVOH for information on how to prepare and inject a dose of OMVOH, and how to properly throw away (dispose of) used OMVOH prefilled pens or prefilled syringes.
• OMVOH comes as 2 different types of 1-time use devices:
  • a prefilled pen,
  • a prefilled syringe.

    Your healthcare provider will decide which type of device is best for you.

• For ulcerative colitis, you will need to inject one 200 mg/2 mL prefilled pen or 200 mg/2mL (100 mg/mL) prefilled syringe, or two 100 mg/mL prefilled pens or prefilled syringes for your full dose.
  • If 2 injections are required for your full dose, inject 1 OMVOH prefilled pen or prefilled syringe followed right away by the other OMVOH prefilled pen or prefilled syringe.
• For Crohn's disease, you will need 2 injections either with 2 prefilled pens or 2 prefilled syringes for your full dose.
  • You will need to inject one OMVOH 100 mg/mL prefilled pen or prefilled syringe and one 200 mg/2 mL prefilled pen or 200 mg/2 mL (100 mg/mL) prefilled syringe in any order.
• Injecting OMVOH under your skin:
  • OMVOH is intended for use under the guidance and supervision of your healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of OMVOH at home, you should receive training on the correct way to prepare and inject OMVOH. Do not try to inject OMVOH yourself until you or your caregiver have been shown how to inject OMVOH.
  • Inject OMVOH under the skin in your stomach area (abdomen), upper legs (thighs), or back of the upper arms.
  • Do not give an injection in an area that is tender, bruised, red, or hard.
  • Use a different injection site each time you use OMVOH.
• If you miss a dose of OMVOH, inject the missed dose as soon as possible. Then take your next dose in 4 weeks. If you have questions about how often you should use OMVOH, talk to your healthcare provider.