Latinib

Lapatinib INN

COMPOSITION: Each tablet contains Lapatinib 250mg as Lapatinib Ditosylate Monohydrate INN.

INDICATIONS: Lapatinib is 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 oftreatment with Lapatinib 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 in combination with an aromatase inhibitor has not been compared to a Trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

DOSAGE AND ADMINISTRATION: Recommended Dosing: HER2-Positive Metastatic Breast Cancer: The recommended dose of Lapatinib is 1,250 mg given orally once daily on Days 1-21 continuously in combination with Capecitabine 2,000 mg/m2/day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21-day cycle. Lapatinib should be taken at least one hour before or one hour after a meal. The dose of Lapatinib should be once daily (5 tablets administered all at once); dividing the daily dose is not recommended. Capecitabine should be taken with food or within 30 minutes after food. If a day’s dose is missed, the patient should not double the dose the next day. Treatment should be continued until disease progression or unacceptable toxicity occurs. Hormone Receptor-Positive, HER2-Positive Metastatic Breast Cancer: The recommended dose of Lapatinib is 1,500 mg given orally once daily continuously in combination with Letrozole. When coadministered with Lapatinib, the recommended dose of Letrozole is 2.5 mg once daily. Lapatinib should be taken at least one hour before or one hour after a meal. The dose of Lapatinib should be once daily (6 tablets administered all at once); dividing the daily dose is not recommended. Or, as directed by the registered physicians.

Use in Pregnancy& Lactation: Based on findings in animal studies and its mechanism of action, Lapatinib can cause fetal harm when administered to a pregnant woman. There are no available human data to inform of the drug associated risks. Advise pregnant women and females of reproductive potential of the potential risk to the fetus.

Packing: Each container contains 30 tablets in a box.