No.14. Pemigatinib-(PEMAZYRE)- (Apr 2020)

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Ocular Toxicity -                                                                                                                          Advise patients that PEMAZYRE may cause ocular toxicity including RPED and to immediately inform their healthcare provider if they experience any visual changes.               Also advise patients that they should use artificial tear or substitutes, hydrating or lubricating eye gels in order to prevent or treat dry eyes 

Hyperphosphatemia -                                                                                                                  Inform patients that they may experience increase in phosphate levels and of the need to monitor serum phosphate levels.

They should immediately inform their healthcare provider of any symptoms related to acute change in phosphate levels such as muscle cramps, numbness, or tingling around the mouth  

Nail Disorders-                                                                                                                         Advise patients that PEMAZYRE may cause nail disorders  

Embryo-Fetal Toxicity-                                                                                                             Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of pregnancy

 Advise females of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose.

 Advise males with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 1 week after receiving the final dose of PEMAZYRE

Lactation-                                                                                                                                    Advise patients not to breastfeed during treatment with PEMAZYRE and for 1 week after the final dose 

Administration -                                                                                                                         Instruct patients do not crush, chew, split or dissolve tablets. 

Instruct patients if they miss a dose by 4 or more hours or if they vomit after taking a dose, resume dosing with the next scheduled dose.

Extra tablets should not be taken to make up for the missed dose

Drug Interactions-                                                                                                                      Advise patients to inform their healthcare providers of all concomitant medications, herbal and dietary supplements. Advise patients to avoid grapefruit products during treatment with PEMAZYRE 

Manufactured for: Incyte Corporation Wilmington, DE 19803 PEMAZYRE is a trademark of Incyte Corporation. U.S. Patent Nos. 9,611,267 and 10,131,667 © 2020 Incyte Corporation. All rights reserved.