Prescribing Information

BMS products are approved in a variety of indications. Below, we provide an overview of all Swissmedic approved indications and the respective approval text. Do not hesitate to contact us if you have any questions.

Indication
Dosing and Monitoring in Ulcerative colitis
Report side effects or undesirable effects (pharmacovigilance) or complaints regarding product quality

Healthcare professionals are asked to report any suspected adverse reactions to Swissmedic. Forms to report adverse drug reactions to Swissmedic can be found here:

www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance.html

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance/forms.html

 

Adverse reactions should also be reported to Bristol-Myers Squibb Medical Information at Hinterbergstrasse 16, 6312 Steinhausen.

Phone: + 41(0)41 767 72 55

Email: medinfo.switzerland@bms.com


Indications of Zeposia®

Ulcerative colitis

EN: Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

DE: Zeposia® ist Indiziert zur Behandlung von erwachsenen Patienten mit mittelschwerer bis schwerer aktiver CU, die entweder auf konventionelle Therapien oder die Behandlung mit einem Biologikum ungenügend angesprochen haben, nicht mehr ansprechen oder die Therapie nicht tolerierten.

FR: Zeposia® est indiqué pour le traitement des patients adultes atteints de RCH active modérée a sévère chez qui les traitements conventionnels ou le traitement par un agent biologique ont eu une réponse inadéquate, ne répondent plus ou n’ont pas été tolérés.

IT: Zeposia® è indicato per il trattamento di pazienti adulti con CU attiva da moderata a grave, che non hanno risposto in modo adeguato alle terapie convenzionali o al trattamento con un farmaco biologico, non rispondono più o non hanno tollerato la terapia.

Multiple sclerosis

EN: Zeposia® is indicated for the treatment of adult patients with relapsing mulitple sclerosis (MS).

DE: Zeposia® ist Indiziert zur Behandlung von erwachsenen Patienten mit schubförmigen remittierend verlaufender Mutipler Sklerosis. 

FR: Zeposia® est indiqué pour le traitement des patients adultes atteints de sclérose en plaques rémittente récurrente (SEP).

IT: Zeposia® è indicato per il trattamento di pazienti adulti con sclerosi multipla (SM) recidivante-remittente.


Dosing and Monitoring in patients treated with Zeposia®

Initial dose escalation schedule for all patients1
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1 Product Information for professionals Zeposia® , www.swissmedicinfo.ch, status may 2022.


  • Initiation of ozanimod therapy with starter pack (day 1 to 7)
  • Maintenance dose of 0.92 mg ozanimod once a day from day 8

One-time Screenings Prior to First Dose to Start Patients on ZEPOSIA® 

CBC, Complete Blood Count; ECG, electrocardiogram; BP, Blood Pressure; HR, Heart Rate. *concomitant medication not recommended: e.g. inducers of CYP2C8; Monoamine oxidase inhibitors, antineoplastic, immunomodulatory, or immunosuppressive therapies Product Information for professionals Zeposia® , www.swissmedicinfo.ch, status may 2022.


Monitoring requirements on ZEPOSIA® 

CBC, Complete Blood Count * Ophthalmological evaluation is recommended for patients with diabetes mellitus, uveitis or a history of retinal disease prior to treatment initiation with follow up. Adapted from Product Information for professionals Zeposia® (ozanimod),  www.swissmedicinfo.ch, status may 2022.


Monitoring requirements after discontinuing ZEPOSIA® 

Adapted from Product Information for professionals Zeposia® (ozanimod),  www.swissmedicinfo.ch, status may 2022.

The full prescribing information for Zeposia® including all monitoring requirements can be found here.


10/2022 IMM-CH-2200034