Omvoh

Omvoh (mirikizumab-mrkz) is used to treat moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) in adults. It is given by intravenous infusion for the first three doses, then as a subcutaneous injection every 4 weeks for maintenance.

Omvoh is a selective interleukin-23 (IL-23) inhibitor. IL-23 is a protein that activates immune cells, driving intestinal inflammation. By blocking IL-23 from binding to its receptor, Omvoh reduces inflammation, promotes healing of intestinal tissue, and helps maintain remission in inflammatory bowel disease (IBD).

Omvoh gained FDA approval on October 26, 2023, for ulcerative colitis, with approval later expanded to Crohn's disease. Approval for UC was based on the LUCENT Phase 3 clinical trials, in which 65% of patients achieved a clinical response, and 24% achieved remission after 12 weeks, compared with 43% and 15% on placebo. For Crohn's disease, the VIVID-1 trial showed 53% of patients achieved clinical remission at one year versus 36% on placebo.

There is currently no Omvoh biosimilar available.

Omvoh is given in two phases: an induction phase by intravenous (IV) infusion and a maintenance phase by subcutaneous injection.

• You will receive your first 3 doses through a vein in your arm (IV infusion) at a healthcare facility every 4 weeks.
• Each infusion lasts about 30 minutes for ulcerative colitis and about 90 minutes for Crohn's disease.
• After the IV infusions, you continue Omvoh as a subcutaneous injection every 4 weeks.

Omvoh comes as two single-use device types: a prefilled pen and a prefilled syringe.

• Your healthcare provider will decide which is best for you, and may allow you or a caregiver to inject at home after proper training.
• Inject Omvoh under the skin of your abdomen, thighs, or the back of the upper arms, rotating the injection site each time and avoiding areas that are tender, bruised, red, or hard.

Do not receive Omvoh if you are allergic to mirikizumab-mrkz, Omvoh, or any of its inactive ingredients.

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

• an infection
• liver disease
• Tuberculosis (TB) or a history of TB
• have recently received or are scheduled to receive a vaccine. You should be up to date with all age-appropriate vaccines before starting Omvoh and should avoid live vaccines right before, during, or right after treatment. Also tell your provider if you are pregnant, planning to become pregnant, or breastfeeding
• are pregnant, or plan to become pregnant
• are breastfeeding, or plan to breastfeed.

Omvoh is not approved for use in children under 18.

Pregnancy

It is not known if Omvoh will harm your unborn baby. There is a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while receiving this medicine, you are encouraged to 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 your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Omvoh.

Common side effects

The most common side effects of Omvoh in people treated for ulcerative colitis are:

• Upper respiratory tract infections
• Injection site reactions, such as redness, pain, or swelling at the injection site
• Joint pain
• Headache
• Rash
• Herpes viral infections.

The most common side effects of Omvoh in people treated for Crohn's disease are:

• Upper respiratory tract infections
• Injection site reactions, such as redness, pain, or swelling at the injection site
• Elevated liver blood tests
• Headache
• Joint pain.

Serious side effects

Omvoh can cause serious side effects, including serious allergic reactions, infections, and liver problems.

• Serious allergic reactions may be life-threatening and require hospital treatment. Stop using Omvoh and get emergency medical help right away if you develop fainting, dizziness, or lightheadedness; swelling of the face, eyelids, lips, mouth, tongue, or throat; trouble breathing, throat tightening, or wheezing; chest tightness; fast heartbeat; severe itching, hives, or redness all over the body; or sweating
• Infections. Omvoh may lower your immune system's ability to fight infections. Your healthcare provider should not start Omvoh if you have an active infection, and may test or treat you for tuberculosis (TB) before and during treatment. Tell your provider before starting Omvoh if you have signs of infection, such as fever, chills, muscle aches, cough or shortness of breath, blood in your phlegm, flu-like symptoms, warm or painful skin, diarrhea or stomach pain, weight loss, nausea or vomiting, or pain during urination.
• Liver problems. Omvoh may cause liver problems. Your healthcare provider will check your liver enzyme and bilirubin levels before treatment, for at least 24 weeks during treatment, and possibly afterward. Tell your provider right away if you develop an unexplained rash, nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of the skin or eyes (jaundice), or dark urine.

Tell your healthcare provider if you have side effects that bother you or that do not go away.

These are not all the possible side effects of Omvoh. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Omvoh (mirikizumab-mrkz) works by targeting and blocking interleukin-23 (IL-23), a protein that drives intestinal inflammation in inflammatory bowel disease. IL-23 normally activates immune cells that release inflammatory chemicals. By preventing IL-23 from binding to its receptor, Omvoh reduces immune cell activity, decreases inflammation, heals intestinal tissue damage, maintains clinical remission, and reduces IBD flares.

Omvoh belongs to the drug class known as interleukin inhibitors. Specifically, it is a selective IL-23 inhibitor.

The cost of Omvoh varies depending on your insurance coverage and pharmacy. Eligible, commercially insured patients may pay as little as $0 to $5 per treatment through the Omvoh Savings Program.

Lilly Support Services offers additional help with insurance, infusion scheduling, injection training, and sharps disposal.

See Omvoh Prices, Coupons, Copay Cards & Patient Assistance for more information.

Dose of Omvoh for Ulcerative Colitis

• Induction (Weeks 0, 4, 8): 300 mg by IV infusion over 30 minutes
• Maintenance (Week 12, then every 4 weeks): 200 mg subcutaneously

Dose of Omvoh for Crohn's Disease

• Induction (Weeks 0, 4, 8): 900 mg by IV infusion over 90 minutes
• Maintenance (Week 12, then every 4 weeks): 300 mg subcutaneously

If you miss a dose of Omvoh, inject the missed dose as soon as possible, then resume your schedule every 4 weeks. Talk to your healthcare provider if you have questions about your dosing schedule.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Omvoh reduces inflammatory cytokines that suppress CYP450 enzymes, which may alter how some other medicines are metabolized.

Your provider may monitor drug levels and adjust doses of CYP450 substrates when starting or stopping Omvoh. Avoid live vaccines (such as varicella, MMR, or rotavirus) during treatment.

Store Omvoh in its original carton in the refrigerator between 36°F and 46°F (2°C and 8°C).

• Do not freeze or shake.
• Keep in the original carton to protect from light.
• If needed, prefilled pens or syringes may be stored at room temperature (below 86°F / 30°C) for up to 2 weeks.
• Once stored at room temperature, do not return to the refrigerator.
• Keep out of reach of children.

Active: mirikizumab-mrkz.

Inactive ingredients:

• Intravenous infusion: anhydrous citric acid, polysorbate 80, sodium chloride, sodium citrate, and Water for Injection. Some formulations may also contain histidine, L-histidine hydrochloride monohydrate, and mannitol.
• Subcutaneous injection: histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, and Water for Injection.

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

Available as:

• 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
• Injection for intravenous infusion (single-dose vial): 300 mg/15 mL (20 mg/mL)

Omvoh (mirikizumab-mrkz) is manufactured by Eli Lilly and Company (Lilly), Indianapolis, IN 46285, USA.US License No. 1891.