No.17- Capmatinib- (TABRECTA)- (MAY- 2020)

PATIENT COUNSELING INFORMATION

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

Interstitial Lung Disease (ILD)/Pneumonitis-                                                       Inform patients of the risks of severe or fatal ILD/pneumonitis.

Advise patients to immediately contact their healthcare provider for new or worsening respiratory symptoms .

Hepatotoxicity-                                                                                                       Inform patients that they will need to undergo lab tests to monitor liver function. Advise patients to immediately contact their healthcare provider for signs and symptoms of liver dysfunction 

Risk of Photosensitivity                                                                                        Inform patients that there is a potential risk of photosensitivity reactions with TABRECTA.

Advise patients to limit direct ultraviolet exposure by using sunscreen or protective clothing during treatment with TABRECTA 

Embryo-Fetal Toxicity-                                                                                          Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy 

Use in Specific Populations-                                                                               . Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose 

Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose 

Drug Interactions-                                                                                                      Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products 

Lactation-                                                                                                                 Advise women not to breastfeed during treatment with TABRECTA and for 1 week after the last dose 

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