No.11. Ozanimod- (ZEPOSIA)- (Mar 2020)

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Infections-                                                                                                 Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking ZEPOSIA and for 3 months after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection 

Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.

Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with ZEPOSIA. If immunizations are planned, administer at least 1 month prior to initiation of ZEPOSIA.

Avoid the use of live attenuated vaccines during and for 3 months after treatment with ZEPOSIA.

Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating ZEPOSIA.

Cardiac Effects-                                                                                                    Advise patients that initiation of ZEPOSIA treatment may result in a transient decrease in heart rate. Inform patients that to reduce this effect, dose titration is required.

Advise patients that the dose titration is also required if a dose is missed for 1 day or more during the first 14 days of treatment.

Liver Injury Inform patients that ZEPOSIA may increase liver enzymes.

Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.

Pregnancy and Fetal Risk-                                                                                    Inform patients that, based on animal studies, ZEPOSIA may cause fetal harm.

Discuss with women of childbearing age whether they are pregnant, might be pregnant, or are trying to become pregnant.

Advise women of childbearing potential of the need for effective contraception during treatment with ZEPOSIA and for 3 months after stopping ZEPOSIA.

Advise a female patient to immediately inform her healthcare provider if she is pregnant or planning to become pregnant.

Respiratory Effects-                                                                                             Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea 

Macular Edema-                                                                                                    Advise patients that ZEPOSIA may cause macular edema, and that they should contact their healthcare provider if they experience any changes in their vision.

Inform patient with diabetes mellitus or a history of uveitis that their risk of macular edema maybe increased 

Posterior Reversible Encephalopathy Syndrome-                                                Advise patients to immediately report to their healthcare provide any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure.

Inform patients that delayed treatment could lead to permanent neurological consequences 

Severe Increase in Disability After Stopping ZEPOSIA-                                       Inform patients that severe increase in disability has been reported after discontinuation of a S1P receptor modulator like ZEPOSIA.

Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of ZEPOSIA 

Immune System Effects- After Stopping ZEPOSIA-                                                       Advise patients that ZEPOSIA continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 3 months after the last dose

Manufactured for:                                                                                                Celgene Corporation Summit, NJ 07901 ZEPOSIA® is a registered trademark of Celgene Corporation. Patent: www.celgene.com/therapies © 2019-2020 Celgene Corporation. All Rights Reserved. ZEPPI/ZEPMG.001