Pronunciation: MIR-i-KIZ-ue-mab
Generic name: mirikizumab-mrkz
Brand name: Omvoh
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 Apr 13, 2025.

What is mirikizumab?

Mirikizumab (Omvoh) is used for moderate to severe ulcerative colitis or Crohn's disease in adults. It is an injection that can be self-administered once every 4 weeks. 

Mirikizumab's mechanism of action involves targeting an immune system protein called interleukin-23 (IL-23), which usually helps coordinate immune responses. In inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease, IL-23 can become overactive and trigger excessive inflammation. Clinical trials show Omvoh effectively reduces intestinal inflammation with a minimal impact on other immune functions. It belongs to the drug class called interleukin inhibitors.

Mirikizumab gained FDA approval on October 26, 2023, under the brand Omvoh. There is no generic or biosimilar.

Side effects

The most common side effects of mirikizumab in ulcerative colitis are:

• upper respiratory infections
• injection site reactions
• joint pain
• headache
• rash
• herpes viral infections.

The most common side effects of mirikizumab in Crohn's disease are:

• upper respiratory infections
• injection site reactions
• elevated liver blood tests
• headache
• joint pain.

Serious side effects

Mirikizumab can cause the following serious side effects:

• Severe Allergic Reactions, such as anaphylaxis. Some reactions may be fatal. Get emergency medical help if you develop symptoms such as:

• • dizziness, fainting, or low blood pressure
  • breathing difficulties, throat tightness, or wheezing
  • rapid heartbeat or chest pounding
  • facial swelling (including eyelids, lips, mouth, tongue)
  • difficulty swallowing
  • chest tightness
  • intense itching, widespread hives, or redness
  • excessive sweating.
• Increased Infection Risk. Omvoh may suppress your immune system or decrease how effective it is at fighting infections. Your doctor:

• • should delay treatment if you have an active infection
  • will screen for tuberculosis (TB) before starting treatment
  • may prescribe TB medication if needed.

Avoid the use of live vaccines while you are being administered mirikizumab. Medicines such as mirikizumab that affect your immune system may increase your risk of an infection after receiving a live vaccine. Contact your doctor immediately if you notice:

• • fever, chills, or sweating
  • flu-like symptoms
  • digestive problems (diarrhea, stomach pain)
  • muscle aches
  • headaches
  • unexplained weight loss
  • respiratory issues (cough, shortness of breath)
  • skin sores or infections
  • nausea or vomiting
  • blood in mucus
  • painful urination.
• Liver Complications. Your healthcare provider will monitor your liver function through blood tests:

• • before treatment begins
  • regularly during treatment (at least 24 weeks)
  • possibly after treatment ends.

Seek medical attention if you develop:

• • unexplained rash
  • unusual fatigue
  • nausea or appetite loss
  • vomiting
  • yellowing of skin or eyes
  • abdominal pain
  • dark urine.

It is not known if mirikizumab is safe and effective in children under the age of 18.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of mirikizumab. 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

Before taking

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

• a history of allergic reactions to mirikizumab, Omvoh, 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 mirikizumab 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 mirikizumab will harm your unborn baby. You should use effective contraception before and during treatment.

If you become pregnant while taking mirikizumab, 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).

If your unborn baby has been exposed to mirikizumab while in the womb, it should be monitored for the development of serious infections during the first 2 months of its life. Mirikizumab may interfere with an infant’s immune response to infections. 

Breastfeeding

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

How is mirikizumab administered?

You will receive your first 3 doses of mirikizumab through a vein in your arm (intravenous infusion) in a healthcare facility by a healthcare provider.

• 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 mirikizumab as an injection under the skin (subcutaneous injection) every 4 weeks.

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

Available 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 mirikizumab prefilled pen or prefilled syringe, followed right away by the other mirikizumab 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.

Mirikizumab 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 into skin that is tender, bruised, red, or hard.
• Use a different injection site each time you use mirikizumab.

Dosing information

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

Dose for Ulcerative Colitis:

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

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

Dose for Crohn's disease:

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

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

What happens if I miss a dose?

If you miss a dose of mirikizumab, 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 mirikizumab?

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

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 mirikizumab 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

Mirikizumab is only available as Omvoh.

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

Mirikizumab is manufactured by Eli Lilly and Company (commonly known as Lilly) under the brand Omvoh. Lilly is a major pharmaceutical company headquartered in Indianapolis, Indiana.

Mirikizumab 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 mirikizumab.

Further information

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

Medical Disclaimer