Omvoh

Pronunciation: ahm-VOH
Generic name: mirikizumab-mrkz
Dosage forms: single-use vial, subcutaneous injectable
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 8, 2023.

What is Omvoh?

Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist that may be used to treat adults with moderately to severely active ulcerative colitis which is given by injection either into a vein (intravenously) or under the skin (subcutaneously).

Omvoh works by selectively targeting the p19 subunit of interleukin (IL) 23 to inhibit the IL-23 pathway. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. By blocking interleukin 23, Omvoh inhibits the release of cytokines and chemokines that cause inflammation.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by inflammation and ulcers on the inner lining of the large intestine. The inflammation in UC is thought to be caused in part by over-activation of the interleukin-23 (IL-23) pathway.

Omvoh was FDA-approved on October 26, 2023.

Warnings

Should not be given to people with a history of serious hypersensitivity reaction to Omvoh, mirikizumab-mrkz, 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.

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

Before taking

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

• A history of hypersensitivity reactions to Omvoh or any of its ingredients in the formulation
• A current infection or a history of infections
• Tuberculosis or have had TB
• Liver disease
• Recently received or are scheduled to receive any vaccinations. You should be brought up to date with all age-required vaccines before starting treatment. Avoid receiving live vaccines right before, during, or right after treatment with Omvoh.

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

It is not known if Omvoh will harm your unborn baby. You should use effective contraception during treatment. If you inadvertently 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).

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

How is Omvoh administered?

Before administering Omvoh your healthcare provider should:

• Ensure you do not have a tuberculosis infection.
• Conduct laboratory tests to establish what your liver enzymes and bilirubin levels are.
• Complete all your age-appropriate vaccinations according to current immunization guidelines.

Your first 3 doses of Omvoh are administered 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.

After your intravenous infusions, you will continue to receive Omvoh as an injection under the skin (subcutaneous injection) every 4 weeks. Your healthcare provider can do this or you can be taught how to self-administer it under your skin.

• Omvoh comes as a single-use prefilled pen.
• For your full dose, you will need 2 injections. Inject 1 Omvoh prefilled pen followed right away by the other Omvoh prefilled pen.
• 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 it yourself until you or your caregiver have been shown how to do so.
• Omvoh may be injected 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.

Dosage

• The recommended starting (induction) dosage of Omvoh 300 mg is administered by intravenous infusion by a healthcare provider over at least 30 minutes at Weeks 0, 4, and 8.
• The recommended maintenance dosage is 200 mg which can be self-administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.

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 are the side effects of Omvoh?

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.

The most common side effects of Omvoh occurring in 2% or more people 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.

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.

What other drugs will affect Omvoh?

No drug-drug interaction studies have been conducted in subjects with ulcerative colitis at the recommended dosage.

Medicines that interact with the immune system, such as Omvoh, may increase your risk of getting an infection after receiving live vaccines.

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 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 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 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.

Prefilled pens 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 solution.

Manufacturer

Eli Lilly and Company.

Further information

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

Medical Disclaimer