Composition: Each tablet is comprised of 40 mg of Neratinib, presented as Neratinib Maleate INN.

Indications: For the Extended Adjuvant Treatment of Breast Cancer in its Early Stages: As a monotherapy, Hertinib is approved for the extended adjuvant treatment of adult patients with early-stage breast cancer that is human epidermal growth factor receptor 2 (HER2)-positive, following adjuvant therapy based on Trastuzumab. For Advanced or Metastatic Breast Cancer: Hertinib, used in combination with Capecitabine, is recommended for adults with HER2-positive breast cancer that is either advanced or metastatic, especially for those who have undergone two or more previous anti-HER2 therapy regimens in the metastatic scenario.

Dosage and Administration: To prevent diarrhea, which is common during the initial two treatment cycles (56 days), antidiarrheal prophylaxis is advised from the first dose of Hertinib. For those with diarrhea not relieved by loperamide, additional antidiarrheal medications may be necessary. Adjustments to the Hertinib dose or temporary treatment pauses may be needed to manage diarrhea. The prescribed dose for Hertinib is 240 mg, equivalent to six tablets, taken orally once daily alongside food for a duration of one year. It’s important for patients to take Hertinib consistently at the same time each day. Tablets must be consumed whole, without chewing, crushing, or splitting. If a dose is missed, the patient should not attempt to take an extra dose but should continue with their next scheduled dose as normal. Follow the advice of healthcare professionals for any deviations.

Pregnancy and Breastfeeding Considerations: There is a risk that Hertinib could harm an unborn baby if taken during pregnancy. Due to the lack of data on its use in pregnant women, the potential risk to the fetus should be communicated to pregnant patients.

Packaging: The product is available in boxes, each containing 30 tablets.