SAFETY SUMMARY WITH WARNINGS
Warnings - 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. Do not use Omvoh if you have had a serious allergic reaction to mirikizumab-mrkz or any of the ingredients in Omvoh. See the Medication Guide that comes with Omvoh for a list of ingredients. 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
- swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
- trouble breathing, throat tightening, or wheezing
- chest tightness
- fast heartbeat or tightening in your chest
- 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. If you have an infection, your healthcare provider should not start treatment with Omvoh until your infection is gone. After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches and pain
- cough or shortness of breath
- blood in your mucus
- 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
Before starting treatment with Omvoh, your healthcare provider should test you for tuberculosis (TB). If 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.
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 treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- unexplained rash
- nausea
- vomiting
- abdominal pain
- feeling tired
- loss of appetite
- yellowing of the skin or the whites of your eyes
- dark urine
Common side effects
The most common side effects of Omvoh include:
- Upper respiratory infections
- Joint pain
- Injection site reaction
- Headache
- Rash
- Herpes viral infections
These are not all the possible side effects of Omvoh.
Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Before you use Omvoh, review these questions with your doctor:
- Are you being treated for an infection?
- Do you have an infection that does not go away or keeps coming back?
- Do you have TB or have you been in close contact with someone with TB?
- Do you have any possible symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination?
Tell your doctor about all your medical conditions, including if:
- You have a history of serious allergic reaction to Omvoh, any infections or liver problems.
- You need any vaccines or have had one recently. Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines.
- You are pregnant, or plan to become pregnant. It is not known if Omvoh will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while taking Omvoh, you are encouraged to report your pregnancy to Eli Lilly and Company at 1-800-545-5979.
- You are breastfeeding or plan to breastfeed. It is not known if Omvoh passes into your breastmilk.
- You take prescription or over-the-counter medicines, vitamins, and herbal supplements.
How to take
Use Omvoh exactly as your healthcare provider tells you to. You will first receive Omvoh through a vein in the arm (intravenous infusion) given by a healthcare provider. You will then continue to receive Omvoh as an injection under the skin (subcutaneous injection). Omvoh is intended for use under the guidance and supervision of your doctor. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the correct way to prepare and inject Omvoh. Read the detailed Instructions for Use that come with the Omvoh prefilled pen for information about how to use Omvoh the correct way.
Learn more
Omvoh is a prescription medicine. For more information, call 1-800-545-5979 or go to Omvoh.com.
This summary provides basic information about Omvoh but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Omvoh and how to take it. Your doctor is the best person to help you decide if Omvoh is right for you.
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Omvoh™ and its delivery device base are trademarks owned by Eli Lilly and Company.