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Omvoh Prescribing Information
Indications and Usage
1/2025
Dosage and Administration
1/2025
OMVOH is indicated for the treatment of:
moderately to severely active ulcerative colitis in adults.
moderately to severely active Crohn's disease in adults.
Prior to Treatment Initiation
Evaluate patients for tuberculosis (TB) infection.
Obtain liver enzymes and bilirubin levels.
Complete all age-appropriate vaccinations according to current immunization guidelines.
Important Administration Instructions
The 200 mg/2 mL prefilled pen and prefilled syringe are only for maintenance treatment of Crohn's disease.
Recommended Dosage for Ulcerative Colitis
Induction Dosage
: Week 0, Week 4, and Week 8: Infuse 300 mg intravenously over at least 30 minutes.
Maintenance Dosage
: Week 12 and every 4 weeks thereafter: Inject 200 mg subcutaneously (given as two consecutive injections of 100 mg each).
Recommended Dosage for Crohn's Disease
Induction Dosage
: Week 0, Week 4, and Week 8: Infuse 900 mg intravenously over at least 90 minutes.
Maintenance Dosage
: Week 12 and every 4 weeks thereafter: Inject 300 mg subcutaneously (given as two consecutive injections of 100 mg and 200 mg in any order).
Preparation and Administration Instructions
See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection.
OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as:
Intravenous Infusion: Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial
Subcutaneous Use: Injection: 100 mg/mL solution in a single-dose prefilled pen Injection: 100 mg/mL solution in a single-dose prefilled syringe Injection: 200 mg/2 mL solution in a single-dose prefilled pen Injection: 200 mg/2 mL (100 mg/mL) solution in a single-dose prefilled syringe
Pregnancy Exposure Registry
There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OMVOH during pregnancy. Pregnant women exposed to OMVOH and healthcare providers are encouraged to call Eli Lilly and Company at 1-800-Lilly-Rx (1-800-545-5979).
OMVOH is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients
[see Warnings and Precautions ]
.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available