INDICATIONS AND USAGE（适应症）

Extended Adjuvant Treatment of Early-Stage Breast Cancer

NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy.

Advanced or Metastatic Breast Cancer

NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

DOSAGE（服用剂量）

Extended Adjuvant Treatment of Early-Stage Breast Cancer

The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily, with food, continuously until disease recurrence or for up to one year.

Advanced or Metastatic Breast Cancer

The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily with food on Days 1–21 of a 21-day cycle plus capecitabine (750 mg/m 2 given orally twice daily) on Days 1–14 of a 21-day cycle until disease progression or unacceptable toxicities.

ADVERSE REACTIONS（不良反应）

Diarrhea

Hepatotoxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/d1e41dcf-e82a-47c2-a0ad-6c6eef621834/spl-doc?hl=nerlynx

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