Omvoh Injection

Uses of Omvoh Injection

Omvoh is used to treat moderate to severe ulcerative colitis or Crohn’s disease in adults. This prescription biologic is given as an IV infusion or a subcutaneous injection once every 4 weeks.

Precautions and Warnings

Should not be given to people with a history of serious hypersensitivity reaction 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 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, or plan to become pregnant, are breastfeeding, or plan to breastfeed.

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.

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.

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.

Dosage

Dose for Ulcerative Colitis:

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

• For ulcerative colitis, each infusion will last about 30 minutes.

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

• For ulcerative colitis, you will need to inject two 100 mg/mL prefilled pens or prefilled syringes.

Dose for Crohn’s disease:

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

• For Crohn’s disease, each infusion will last about 90 minutes.

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

• 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.

Side Effects

Common Side Effects:

• 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:

• 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.