lapatinib
lapatinib is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand names including Lapatinib, TYKERB. Available dosage forms: tablet, powder.
Drug Details
- Generic Name
- lapatinib
- Brand Names
- Lapatinib, TYKERB
- Application Number
- ANDA203007
- Sponsor
- Lupin Pharmaceuticals, Inc.
- NDC Codes
- 3
- Dosage Forms
- TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- LAPATINIB DITOSYLATE, LAPATINIB
Indications and Usage
1 INDICATIONS AND USAGE Lapatinib tablets are indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Lapatinib tablets in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer. Lapatinib tablets are a kinase inhibitor indicated in combination with: ( 1 ) capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecitabine. letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated. Lapatinib tablets in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.