No.13- Tucanib-(TUKYSA)- (Apr 2020)

PATIENT COUNSELING INFORMATION

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

• Inform patients that TUKYSA has been associated with severe diarrhea.         Instruct patients on how to manage diarrhea and to inform their healthcare provider immediately if there is any change in bowel patterns

• Inform patients that TUKYSA has been associated with severe hepatotoxicity and that they should report signs and symptoms of liver dysfunction to their healthcare provider immediately 

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

• Advise females of reproductive potential to use effective contraception during treatment with TUKYSA and for at least 1 week after the last dose

• Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TUKYSA and for at least 1 week after the last dose [

• Refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and contraception information.

Lactation                                                                                                                        • Advise women not to breastfeed during treatment with TUKYSA and for at least 1 week after the last dose

Infertility                                                                                                                          • Advise males and females of reproductive potential that TUKYSA may impair fertility 

Manufactured by:                                                                                                 Seattle Genetics, Inc. Bothell, WA 98021 1-855-4SEAGEN TUKYSA is a trademark, and Seattle Genetics and are US registered trademarks of Seattle Genetics, Inc. © 2020 Seattle Genetics, Inc., Bothell, WA 98021.