Pronunciation: ahm-VOH
Generic name: mirikizumab-mrkz
Dosage form: single-use vial for intravenous infusion (300 mg/15 mL), single-dose prefilled pen for subcutaneous use (100 mg/mL, 200 mg/2 mL), single-dose prefilled syringe for subcutaneous use (100 mg/mL, 200 mg/2 mL)
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 19, 2025.

What is Omvoh?

Omvoh is a targeted biologic medication used to treat moderate to severe ulcerative colitis (UC) or Crohn's disease (CD) in adults. This prescription IL-23 inhibitor biologic is given as an IV infusion or subcutaneous injection once every 4 weeks to treat inflammatory bowel disease (IBD).

Omvoh (mirikizumab) 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 Approvals and Indications for IBD Treatment

Omvoh is FDA-approved in adults for moderately to severely active:

• Ulcerative colitis 
• Crohn's disease.

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

How Does Omvoh Work? Mechanism of Action

Omvoh (mirikizumab) is an IL-23 inhibitor that specifically targets and blocks interleukin-23 (IL-23), a key inflammatory cytokine responsible for intestinal inflammation and gut inflammation in IBD. 

• While IL-23 normally helps coordinate immune responses, overactive IL-23 signaling can trigger excessive inflammation in the digestive tract.
• By neutralizing IL-23, this targeted therapy helps normalize immune function and reduce the inflammatory cascade that damages intestinal tissue.
• Clinical trial results demonstrate that this approach helps heal the intestinal lining, achieve remission, and provide effective flare prevention for both UC treatment and CD treatment.
• Omvoh belongs to the drug class called interleukin inhibitors.

Omvoh vs Other Biologic Medications

Omvoh offers a unique approach compared to other IBD treatments:

• Alternative to Stelara: While Stelara targets IL-12/23, Omvoh selectively inhibits only IL-23
• Compared to Entyvio: Omvoh is an IL-23 inhibitor, while Entyvio is a gut-selective integrin antagonist
• Omvoh vs Humira: Humira blocks TNF-alpha, while mirikizumab targets the IL-23 pathway
• Targeted therapy advantage: More selective IL-23 inhibition may reduce some side effects seen with broader immune suppression.

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 do 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 reactions 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, 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.

How is Omvoh Administered?

Administration of Omvoh follows a specific dosing protocol:

• Initial Induction Doses. Treatment begins with higher induction doses administered in a clinical setting by a healthcare provider
• Maintenance Therapy. Following the initial induction doses, you will receive maintenance doses as subcutaneous injections once every 4 weeks
• Self-Administration. After proper training, you should be able to self-administer your maintenance injections at home.

Self-Administration and Injection Sites

After proper training, patients can self-administer maintenance injections at home. Omvoh injection sites include:

• Stomach area (abdomen)
• Upper legs (thighs)
• Back of upper arms (if given by caregiver)

Important injection guidelines:

• Avoid tender, bruised, red, or hard skin
• Use different injection sites for each dose
• Follow the detailed Instructions for Use or proper preparation and disposal.

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

Dosing information

Omvoh Dosage for Ulcerative Colitis:

Induction Phase (Initial Treatment):

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

Maintenance Therapy:

• Week 12 and every 4 weeks: Omvoh 200 mg SC (as 2 consecutive injections of 100 mg).
• You will need two 100 mg/mL prefilled pens or syringes for each dose.

Omvoh Dosage for Crohn's disease:

Induction Phase:

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

Maintenance Therapy:

• Week 12 and every 4 weeks: Omvoh 300 mg SC (one 100 mg injection + one 200 mg injection).
• The 200 mg/2 mL prefilled pen and syringe are specifically for Crohn's disease maintenance.

How Long Does Omvoh Take to Work?

Based on clinical trials results:

• Some patients may see initial improvement within 4-8 weeks during induction
• Full effectiveness timeline typically occurs by week 12-16
• Continued improvement and remission maintenance with ongoing treatment
• Individual response times may vary.

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 (mirikizumab-mrkz) is manufactured by Eli Lilly and Company (Lilly), with headquarters in Indianapolis, Indiana. 

Frequently Asked Questions About Omvoh

How quickly does Omvoh start working?

Omvoh can show early improvements in rectal bleeding and stool frequency as early as three weeks compared to placebo. After 12 weeks, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission.

Full benefits continue to develop over time, with significant improvements in clinical remission and endoscopic response sustained at one year.

Can Omvoh cause weight gain or loss?

Weight gain is not listed among Omvoh's common side effects. However, unexplained weight loss is mentioned as a potential warning sign of serious infection, which requires immediate medical attention.

The most common side effects are upper respiratory infections, joint pain, injection site reactions, rash, and headache. Any unexplained weight changes should be reported to your healthcare provider.

Is Omvoh covered by insurance?

Omvoh costs between $7,124-$14,248 during the 12-24 week initiation phase and $30,977 per year for maintenance. Coverage varies by insurance plan. Contact your insurer and Eli Lilly's patient assistance programs to determine your specific coverage options.

Can Omvoh be taken long-term?

Yes, Omvoh is designed for long-term use. Most patients achieved sustained clinical remission and endoscopic response at two years of treatment. The protocol includes an initial 12-week induction followed by maintenance therapy every 4 weeks indefinitely. Liver monitoring is required for at least 24 weeks, with clinical trials demonstrating safety and effectiveness over 104 weeks of continuous treatment.

Does Omvoh weaken your immune system?

Yes, Omvoh affects immune function as an IL-23 inhibitor, increasing infection risk. Upper respiratory infections are common side effects. Serious infections can cause fever, chills, flu-like symptoms, and unexplained weight loss. Patients must avoid live vaccines and undergo pre-treatment tuberculosis screening.

However, this immune suppression is more targeted than broader immunosuppressive medications, specifically focusing on inflammatory pathways involved in IBD.

Can you switch from another biologic to Omvoh?

While specific switching protocols aren't detailed in available sources, studies show more patients achieved histologic response with mirikizumab (Omvoh) compared to ustekinumab at one year.

Switching requires healthcare provider supervision, possible washout periods, infection re-screening, and individual assessment of treatment history. Your gastroenterologist should evaluate your previous biologic responses and overall health to determine the safest switching strategy.

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.

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Further information

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