SAFETY SUMMARY
Warning:
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 pounding 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.
Before starting treatment with Omvoh, your healthcare provider should assess 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.
Before starting Omvoh, tell your healthcare provider if you think you have an infection or 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 (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 should do blood tests to check your liver enzyme and bilirubin levels before treatment, during, and 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
- stomach-area (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 in people treated for ulcerative colitis include:
- upper respiratory infections
- injection site reactions
- joint pain
- rash
- headache
- herpes viral infections
The most common side effects of Omvoh in people treated for Crohn’s disease include:
- upper respiratory infections
- injection site reactions
- headache
- joint pain
- elevated liver blood tests
These are not all the possible side effects of Omvoh.
Tell your doctor 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 should avoid receiving live vaccines right before, during or right after treatment with Omvoh. Tell your healthcare provider that you are taking Omvoh before receiving a vaccine.
- 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, or herbal supplements.
How to take
Follow your healthcare provider’s instructions for using Omvoh. 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. Each infusion will last about 30 minutes (for ulcerative colitis) or about 90 minutes (for Crohn’s disease). After induction, you will continue to receive Omvoh maintenance doses as self- injections under the skin (subcutaneous injection) every 4 weeks. For these injections, Omvoh is available as prefilled pens or prefilled syringes. For a full dose you will need two injections with either two prefilled pens or two prefilled syringes. Inject 1 Omvoh prefilled pen or prefilled syringe followed right away by the other Omvoh prefilled pen or prefilled syringe. If you give injections at home, you should be trained 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. Read the detailed Instructions for Use about how to use and dispose of Omvoh the correct way.
Learn more
Omvoh is a prescription medicine. During induction, Omvoh is available as a single-dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility. During maintenance, Omvoh is available as:
- For ulcerative colitis: two 100 mg/mL prefilled pens or prefilled syringes.
- For Crohn’s disease: one 100 mg/mL prefilled pen or prefilled syringe and one 200 mg/2 mL prefilled pen or prefilled syringe.
For more information, call 1-800-545-5979.
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 or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.