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.