OH Epic Formulary restricted to:

• Indication: treatment of moderately to severely active ulcerative colitis
• Service line: Gastroenterology
• Formulary location: Outpatient infusion
• Service location: Outpatient infusion, Home infusion
• Patient population: Adults (18 years of age or older)
• Prior authorization required: Yes
• Restriction/criteria of use (all will apply unless specified):
  • Diagnosis of moderately to severely active ulcerative colitis (UC)
  • No hepatitis B or TB infection
    • Screening is required prior to initiating and during therapy
  • No known active infection
  • Females of childbearing potential: documentation of possible fetal risks being discussed with patients.
  • Liver enzymes and bilirubin are monitored at baseline and during induction.
  • Avoid use of live vaccines in patients treated with mirikizumab-mrkz (Omvoh).
  • Not to be used in combination with biologic therapies or targeted disease-modifying anti-rheumatic drugs (DMARDs).
  • Patient has failed/had inadequate response or is intolerant to corticosteroids (e.g. methylPREDNISolone, prednisone or budesonide) OR immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) OR other biologic therapies (e.g. TNF-a antagonists, vedolizumab, or ustekinumab).
  • Patient has failed/had inadequate response ustekinumab (Stelara)

• UpToDate
• Lexicomp
• DailyMed Package Inserts
• Johns Hopkins Guides