Mirikizumab
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
What is mirikizumab?
Mirikizumab (Omvoh) is used to treat moderately to severely active ulcerative colitis or Crohn's disease in adults. This prescription medicine can be self-administered by injection under the skin (subcutaneously) every 4 weeks after an initial series of IV infusions by a healthcare provider. The full generic name is mirikizumab-mrkz.
Mirikizumab was FDA-approved on October 26, 2023, under the brand name Omvoh. There is no generic version.
Mechanism
Mirikizumab works by blocking a protein called interleukin (IL) 23, targeting a specific subunit of this protein called p19. IL-23 helps regulate our immune responses but can become overactive, increasing inflammation. Clinical trials have shown that by selectively blocking IL-23, mirikizumab reduces the release of inflammatory proteins that are thought to contribute to the symptoms of ulcerative colitis and Crohn's disease.
Mirikizumab belongs to the drug class called interleukin-23 antagonists. It may also be called a monoclonal antibody or biologic.
Mirikizumab side effects
The most common side effects of mirikizumab 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
Mirikizumab can cause serious side effects, including:
- Serious allergic reactions that may be life-threatening. Stop using mirikizumab 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 mirikizumab 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 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.
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Warnings
Should not be given to people with a history of serious hypersensitivity reaction to mirikizumab, Omvoh, or any of the ingredients in the formulation. Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported.
Mirikizumab 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 mirikizumab 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 mirikizumab. Medicines such as mirikizumab that affect your immune system may increase your risk of getting an infection after receiving a live vaccine.
It is not known if mirikizumab is safe and effective in children under the age of 18.
Before taking
Before you use mirikizumab, tell your healthcare provider about all your medical conditions, including if you have:
- A history of allergic reactions to 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 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 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).
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?
Your first 3 doses of mirikizumab are administered through a vein in your arm (intravenous infusion) by a healthcare provider every 4 weeks. Each infusion will last about 30 minutes.
Following these initial infusions, you will receive mirikizumab 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. Do not attempt to administer it yourself until your healthcare provider has shown you how.
- Mirikizumab is available as a single-use prefilled pen or prefilled syringe.
Mirikizumab is given 1 time every 4 weeks.
- Mirikizumab 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 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.
Dosage 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).
Dosage 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), a major pharmaceutical company headquartered in Indianapolis, Indiana. Other notable medications by Lilly include:
- Cymbalta (duloxetine) for depression and anxiety
- Humalog and Lyumjev for diabetes
- Taltz for psoriasis and psoriatic arthritis
- Olumiant for rheumatoid arthritis
- Jardiance (in partnership with Boehringer Ingelheim) for diabetes
- Verzenio for HR-positive and HER2-negative breast cancer in adults
- Mounjaro (tirzepatide) for type 2 diabetes and weight management
- Zepbound (tirzepatide) for weight management.
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.
Omvoh (mirikizumab-mrkz) - Eli Lilly and Company
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 100 mg/mL |
Single-Dose Vial | 300 mg/15 mL (20 mg/mL) |
View Omvoh information in detail.
References
More about mirikizumab
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- Drug class: interleukin inhibitors
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.