Tabrecta Patient Counseling 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 [see Interstitial Lung Disease (ILD)/Pneumonitis under Precautions].
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 [see Hepatotoxicity under Precautions].
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 [see Risk of Photosensitivity under Precautions].
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 [see Embryo-Fetal Toxicity under Precautions; Pregnancy under Use in Pregnancy & Lactation].
Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Drug Interactions: Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Interactions].
Lactation: Advise women not to breastfeed during treatment with TABRECTA and for 1 week after the last dose [see Lactation under Use in Pregnancy & Lactation].