ZEPOSIA®Black medical triangle (ozanimod) initiation & dosing

ZEPOSIA®Black medical triangle (ozanimod) initiation & dosing

ZEPOSIA offers oral dosing with one maintenance capsule for patients with moderate-severe UC1

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ZEPOSIA offers oral dosing with one maintenance capsule1

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ZEPOSIA can be taken with or without food1

Please refer to the ZEPOSIA Summary of Product Characteristics for more information

UC, ulcerative colitis

ZEPOSIA dosing schedule1

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No dose adjustment is necessary for patients with renal impairment. Patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) are recommended to complete the 7-day dose escalation regimen, and then take 0.92 mg once every other day. ZEPOSIA was not evaluated in patients with severe hepatic impairment. Therefore, patients with severe hepatic impairment (Child-Pugh class C) must not be treated with ZEPOSIA.1

Pre-initiation and maintenance monitoring requirements

Pre-initiation1

One-time assessment:
  • ECG to rule out any pre-existing heart conditions*
Standard assessments:
  • Recent complete blood cell count (within last 6 months)
    • Lymphocyte count
    • Liver transaminase and bilirubin levels†
  • Exclude contraindications and clarify concomitant medications
  • Confirm a negative pregnancy test in women of childbearing potential
Assessments for specific patients:
  • Evaluate for signs of pre-existing macular oedema in patients with diabetes mellitus, uveitis or a history of retinal disease. An exam conducted with any optician is sufficient
  • Administer live attenuated immunisations (if required) at least 1 month prior to initiation of ZEPOSIA
    • VZV vaccination of patients without documented immunity to VZV is recommended
    • Should be avoided during treatment and for 3 months after

Ongoing monitoring1

Maintenance assessments:
  • Complete blood cell count done periodically throughout treatment
    • Lymphocyte count
  • Liver transaminase and bilirubin levels at Months 1, 3, 6, 9 and 12 on therapy and periodically thereafter†
  • Regularly monitor blood pressure during treatment
Assessments for specific patients:
  • Re-evaluation of macular oedema in patients with diabetes mellitus, uveitis or a history of retinal disease during treatment. An exam conducted with any optician is sufficient

*First dose, hourly monitoring over a 6-hour period is recommended for patients with a resting heart rate <55 bpm, second-degree (Mobitz type I) AV block or a history of myocardial infarction or heart failure. These patients should be monitored for signs and symptoms of bradycardia.1


†Elevations of aminotransferases, gamma-glutamyl transferase (GGT) and bilirubin have been reported in patients treated with ZEPOSIA. Signs of liver injury, including elevated serum hepatic enzymes and elevated total bilirubin, have occurred as early as ten days after the first dose of ZEPOSIA. Severe liver injury may result in the need for a liver transplant.1

Please refer to the ZEPOSIA Summary of Product Characteristics for full safety information.

AV: atrioventricular; bpm: beats per minute; ECG, electrocardiogram; VZV, varicella-zoster virus

Reference

  1. ZEPOSIA (ozanimod) Summary of Product Characteristics, 2024.

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Adverse events should be reported. Reporting forms and information can be found at: UK – www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland-via HPRA Pharmacovigilance at www.hpra.ie Adverse events should also be reported to Bristol-Myers Squibb via medical.information@bms.com or 0800 731 1736 (UK); 1800 749 749 (Ireland).

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Job: 2084-GB-2300276 Date of Preparation: June 2023