Omvoh

Pronunciation: ahm-VOH
Generic name: mirikizumab-mrkz
Dosage form: single-use vial for intravenous infusion, single-dose prefilled pen for subcutaneous use, single-dose prefilled syringe for subcutaneous use
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 3, 2025.

What is Omvoh?

Omvoh (mirikizumab) is used to treat adults with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. This prescription biologic is given as an IV infusion or a subcutaneous injection, and is effective at managing moderate to severe cases of these chronic inflammatory conditions.

Omvoh gained FDA approval on October 26, 2023 and is only available as a brand-name medication manufactured by Eli Lilly and Company. No generic or biosimilar alternatives are currently available.

FDA approval and indications

Omvoh is specifically FDA-approved for:

• moderately to severely active ulcerative colitis in adults
• moderately to severely active Crohn's disease in adults.

The medication is not currently approved for children, and its safety and effectiveness in children remain under investigation.

How does Omvoh work? Mechanism of action

Omvoh specifically targets and blocks interleukin-23 (IL-23), a key inflammatory cytokine. It has selective IL-23 inhibition.

• While IL-23 normally helps coordinate immune responses, overactive IL-23 signaling can trigger excessive inflammation in the digestive tract.
• By neutralizing IL-23, Omvoh helps normalize immune function and reduce the inflammatory cascade that damages intestinal tissue.
• Clinical trials demonstrate that this targeted approach helps heal the intestinal lining and reduce symptoms.

Omvoh side effects

The most common side effects of Omvoh are:

• upper respiratory tract infections
• joint pain
• injection site reactions, such as redness, pain, or swelling at the injection site
• rash
• headache
• herpes viral infections.

Serious side effects

Omvoh can cause serious side effects, including:

• Serious allergic reactions that 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, such as:
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • trouble breathing, throat tightening or wheezing
  • fast heartbeat or pounding in your chest (tachycardia)
  • swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
  • chest tightness
  • severe itching, hives, or redness all over your body
  • sweating.
• Infections, because it may lower the ability of your immune system to fight infections. Your healthcare provider should not start treatment with Omvoh if you currently have an infection until it is gone. They should also test you for tuberculosis (TB), and treat you with medicine if they think you are at risk for TB. Tell your doctor immediately if you think you have an infection, symptoms may include:
  • fever, sweating, or chills
  • flu-like symptoms
  • diarrhea or stomach pain
  • muscle aches and pain
  • headache
  • weight loss
  • cough or shortness of breath
  • warm, red, or painful skin or sores on your body
  • nausea or vomiting
  • blood in your mucus (phlegm)
  • pain during urination.
• 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. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
  • an unexplained rash
  • feeling tired
  • nausea
  • loss of appetite
  • vomiting
  • yellowing of the skin or the whites of your eyes
  • stomach-area (abdominal) pain
  • dark urine.

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. You can report suspected side effects to Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Related/similar drugs

Warnings

Should not be given to people with a history of serious hypersensitivity reaction to Omvoh, mirikizumab, or any of the ingredients in the formulation. Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported.

Omvoh may increase the risk of infection and treatment should not be started in those with an active infection until the infection resolves or is adequately treated. If a serious infection develops, withhold Omvoh until the infection resolves. Should not be administered to people with an active TB infection.

Drug-induced liver injury has been reported. Your healthcare provider will monitor your liver enzymes and bilirubin levels before you start treatment and for at least 24 weeks thereafter. 

You should avoid the use of live vaccines while you are being administered Omvoh. Medicines such as Omvoh that affect your immune system may increase your risk of getting an infection after receiving a live vaccine.

Before taking

Before you receive Omvoh, tell your healthcare provider about all your medical conditions, including if you have:

• A history of allergic reactions to Omvoh, mirikizumab, or any of the inactive ingredients in the injection
• A current infection or a history of infections
• Tuberculosis (TB) or a history of TB
• Liver disease
• Recently received or are scheduled to receive any vaccinations.

Before starting treatment, your doctor should:

• Obtain blood tests for liver enzymes and bilirubin levels
• Bring you up to date with all your age-appropriate vaccines. Avoid receiving live vaccines right before, during, or soon after Omvoh treatment.

Also, tell your doctor if you are pregnant, or plan to become pregnant, are breastfeeding, or plan to breastfeed.

Pregnancy

Clinical trials have not been conducted in pregnant women and it is not known if Omvoh will harm your unborn baby. You should use effective contraception during treatment.

If you become pregnant while taking Omvoh, you should tell your healthcare provider right away and report your pregnancy to Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979).

It is unclear whether Omvoh interferes with an infant’s immune response to infections. Your infant should be monitored for the development of serious infections during its first 2 months of life if it has been exposed to Omvoh while in the womb.

Breastfeeding

It is not known if Omvoh passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

Dosing Schedule and Administration

Omvoh treatment follows a specific dosing protocol:

• Initial Induction Doses: Treatment begins with higher induction doses administered in a clinical setting
• Maintenance Therapy: Following induction, patients receive maintenance doses as subcutaneous injections once every 4 weeks
• Self-Administration: After proper training, many patients can self-administer the maintenance injections at home

See the detailed Instructions for Use that come with Omvoh for information on how to prepare and inject a dose, and how to properly throw away (dispose of) used prefilled pens or syringes.

For your full dose, you will need 2 injections with either 2 prefilled pens or 2 prefilled syringes.

• Inject 1 Omvoh prefilled pen or prefilled syringe followed right away by the other prefilled pen or prefilled syringe.

Omvoh may be injected under the skin in your stomach area (abdomen), upper legs (thighs), or back of the upper arms (if given by a caregiver).

• Do not give an injection in skin that is tender, bruised, red, or hard.
• Use a different injection site each time you use Omvoh.

Dosing information

See the Omvoh Prescribing Information for more detailed dosage and administration instructions.

Omvoh Dose for Ulcerative Colitis:

Week 0, 4, and 8: 300 mg IV over at least 30 minutes.

• For ulcerative colitis, each infusion will last about 30 minutes.

Week 12 and every 4 weeks thereafter: 200 mg SC (as 2 consecutive injections of 100 mg).

• For ulcerative colitis, you will need to inject two 100 mg/mL prefilled pens or prefilled syringes.

Omvoh Dose for Crohn's disease:

Week 0, 4, and 8: 900 mg IV over at least 90 minutes.

• For Crohn’s disease, each infusion will last about 90 minutes.

Week 12 and every 4 weeks thereafter: 300 mg SC (as 2 consecutive injections of 100 mg and 200 mg in any order).

• 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.

What happens if I miss a dose?

If you miss a dose of Omvoh, inject the missed dose as soon as possible. Then take your next dose in 4 weeks.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect Omvoh?

No drug-drug interaction studies have been conducted with Omvoh.

Other medications that affect the immune system may interact with this medicine and increase your risk of getting an infection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Refer to the prescribing information for a full list of interactions.

Storage

Store Omvoh prefilled pens/syringes in a refrigerator at 36°F to 46°F (2°C to 8°C).

• Do not freeze. Do not use it if it has been frozen. Do not shake.
• Keep it in the original carton to protect it from light until the time of use.

After removing your prefilled pens/syringes from the refrigerator, they can be stored at room temperature up to 86°F (30°C) for up to 2 weeks in the original carton to protect them from light. When it has been stored at room temperature, do not return it to the refrigerator.

Throw away (dispose of) your prefilled pens/syringes if they:

• are frozen.
• have been shaken.
• have not been protected from light in the original carton.
• are stored at room temperature for more than 2 weeks.

Keep all medicines out of the reach of children.

Ingredients

Active: mirikizumab-mrkz.

Inactive: anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection.

Omvoh prefilled pens and syringes are not made with dry natural rubber latex.

Available as:

• Injection for intravenous infusion (single-dose vial): 300 mg/15 mL (20 mg/mL)
• Single-dose prefilled pen for subcutaneous injection: 100 mg/mL and 200 mg/2 mL
• Single-dose prefilled syringe for subcutaneous injection: 100 mg/mL and 200 mg/2 mL.

Manufacturer

Omvoh is manufactured by Eli Lilly and Company (Lilly), headquartered in Indianapolis, Indiana. Other notable medications by Lilly include:

• Cymbalta for depression and anxiety
• Humalog and Lyumjev for diabetes
• Jardiance (in partnership with Boehringer Ingelheim) for diabetes
• Mounjaro for type 2 diabetes and weight management
• Olumiant for rheumatoid arthritis
• Taltz for psoriasis and psoriatic arthritis
• Verzenio for HR-positive and HER2-negative breast cancer in adults
• Zepbound for weight management.

Omvoh Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Omvoh.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer