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. 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
Do not use OMVOH if you:
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.
USES
OMVOH is a prescription medicine used to treat:
adults with moderately to severely active ulcerative colitis
adults with moderately to severely active Crohn's disease
It is not known if OMVOH is safe and effective in children.
HOW TO USE
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 your full dose, you will need 2 injections either with 2 prefilled pens or 2 prefilled syringes. Inject 1 OMVOH prefilled pen or prefilled syringe followed right away by the other OMVOH prefilled pen or prefilled syringe.
For ulcerative colitis, you will need to inject two 100 mg/mL prefilled pens or prefilled syringes.
For Crohn's disease, you will need to inject one 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.
The 200 mg/2 mL prefilled pen and 200 mg/2 mL (100 mg/mL) prefilled syringe are only for treatment of Crohn's disease.
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.
The most common side effects of OMVOH in people treated for ulcerative colitis include:
upper respiratory infections
injection site reactions
joint pain
headache
rash
herpes viral infections
The most common side effects of OMVOH in people treated for Crohn's disease include:
upper respiratory infections
injection site reactions
elevated liver blood tests
headache
joint pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of OMVOH. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OMVOH for a condition for which it was not prescribed. Do not give OMVOH to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about OMVOH that is written for health professionals.
What are the ingredients in OMVOH?
Active ingredient: mirikizumab-mrkz.
Inactive ingredients:
Intravenous infusion: anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.
Subcutaneous injection for ulcerative colitis and Crohn's disease: histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, and Water for Injection.
OMVOH prefilled pens and prefilled syringes are not made with dry natural rubber latex.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
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.
STORAGE
In the original carton, store OMVOH prefilled pens and prefilled syringes in a refrigerator between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
Do not freeze. Do not use OMVOH if it has been frozen.
Do not shake.
Keep OMVOH in the original carton to protect from light until the time of use.
If needed, your prefilled pens or prefilled syringes may be stored at room temperature for up to 2 weeks in the original carton. Do not store above 86-degrees F (30-degrees C).
When OMVOH has been stored at room temperature, do not return it to the refrigerator.
Do not use and throw away (dispose of) your prefilled pens and prefilled syringes if they:
have been frozen.
have been shaken.
have not been protected from light in the original carton.
have been stored at room temperature more than 2 weeks.
Keep OMVOH and all medicines out of the reach of children.
NOTES
Medication Guide: revision date 01/2025
Prescribing Information: revision date 01/2025
CYP450 Substrates
Increased concentrations of cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation associated with certain diseases including Crohn's disease may suppress the formation of CYP450 enzymes. Therapeutic proteins, including mirikizumab-mrkz, that decrease the concentrations of these pro-inflammatory cytokines may increase the formation of CYP450 enzymes resulting in decreased CYP450 substrate exposure. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed. See the prescribing information of specific CYP450 substrates.
Before you use OMVOH, tell your healthcare provider about all your medical conditions, including if you:
have any of the conditions or symptoms listed in the section “What is the most important information I should know about OMVOH?”
have recently received or are scheduled to receive any vaccinations. Medicines that affect your immune system may increase your risk of getting an infection after receiving live vaccines.
You should be brought up to date with all age required vaccines before starting treatment with OMVOH.
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.
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-Lilly-Rx (1-800-545-5979).
are breastfeeding or plan to breastfeed. It is not known if OMVOH passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using OMVOH.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
