Description

Neratinib INN Composition: Each tablet contains Neratinib 40 mg as Neratinib Maleate INN. Indications: Extended Adjuvant Treatment of Early-Stage Breast Cancer: Hertinib 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: Hertinib 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 and Administration: Antidiarrheal Prophylaxis: Antidiarrheal prophylaxis is recommended during the first 2 cycles (56 days) of treatment and should be initiated with the first dose of Hertinib. Additional antidiarrheal agents may be required to manage diarrhea in patients with loperamide-refractory diarrhea. Hertinib dose interruptions and dose reductions may also be required to manage diarrhea. The recommended dose of Hertinib is 240 mg (six tablets) given orally once daily with food, continuously for one year. Patients should be instructed to take Hertinib at approximately the same time every day. Hertinib tablets should be swallowed whole (tablets should not be chewed, crushed, or split prior to swallowing). If a patient misses a dose, missed dose should not be replaced, and patients should be instructed to resume Hertinib with the next scheduled daily dose. Or, as directed by the registered physicians. Use in Pregnancy and Lactation: Hertinib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus. Packing: Each container contains 30 tablets in a box.