TUKYSA® Patient Counseling Information

(tucatinib)

17 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 [see Warnings and Precautions (5.1)].

Hepatotoxicity

  • 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 [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
  • Advise females of reproductive potential to use effective contraception during treatment with TUKYSA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
  • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TUKYSA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
  • 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 1 week after the last dose [see Use in Specific Populations (8.2)]. Refer to the Full Prescribing Information of trastuzumab and capecitabine for lactation information.

Infertility

  • Advise males and females of reproductive potential that TUKYSA may impair fertility [see Use in Specific Populations (8.3)].  Refer to the Full Prescribing Information of trastuzumab and capecitabine for infertility information.
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Manufactured for:

Seagen Inc.
Bothell, WA 98021
1-855-4SEAGEN

TUKYSA, Seagen, and small logo are US registered trademarks of Seagen Inc.

© 2023 Seagen Inc., Bothell, WA 98021. All rights reserved.

USPI-213411-v04

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Health Professional Information

Patient Counseling Information

17 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 [see Warnings and Precautions (5.1)].

Hepatotoxicity

  • 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 [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
  • Advise females of reproductive potential to use effective contraception during treatment with TUKYSA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
  • Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TUKYSA and for 1 week after the last dose [see Use in Specific Populations (8.3)].
  • 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 1 week after the last dose [see Use in Specific Populations (8.2)]. Refer to the Full Prescribing Information of trastuzumab and capecitabine for lactation information.

Infertility

  • Advise males and females of reproductive potential that TUKYSA may impair fertility [see Use in Specific Populations (8.3)].  Refer to the Full Prescribing Information of trastuzumab and capecitabine for infertility information.
logo

Manufactured for:

Seagen Inc.
Bothell, WA 98021
1-855-4SEAGEN

TUKYSA, Seagen, and small logo are US registered trademarks of Seagen Inc.

© 2023 Seagen Inc., Bothell, WA 98021. All rights reserved.

USPI-213411-v04

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