Neratinib Maleate/Neratinib Chinese Instructions for Use Guide

1. Overview of drugs

Neratinib maleate/Neratinib is an oral tyrosine kinase inhibitor specifically designed for HER2-positive breast cancer. It blocks the growth and spread of cancer cells by inhibiting the activity of the HER2 receptor, providing a new treatment option for breast cancer patients.

2. Indications

1. Expanded adjuvant treatment of early breast cancer: This drug is suitable for adult patients with HER2-positive early breast cancer who have previously received adjuvant treatment with trastuzumab. It can be used as extended adjuvant treatment to further reduce the risk of recurrence.

2. Treatment of advanced or metastatic breast cancer: For adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more anti-HER2-based regimens, this product can be used in combination with capecitabine to control disease progression.

3. Side effects

Common side effects of neratinib include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle cramps, indigestion, nail abnormalities, dry skin, bloating, nose bleeding, weight loss, and urinary tract infections. While taking neratinib, patients need to pay close attention to their physical condition and seek medical treatment in time if they feel unwell.

4. Usage and dosage

1. Dosage: For patients with early-stage breast cancer, the recommended dose is 240 mg (6 tablets) taken orally once a day, with meals, and continued treatment until disease recurrence or up to one year. For patients with advanced or metastatic breast cancer, the recommended dose is also 240 mg (6 tablets) daily, but taken on days 1 to 21 of a 21-day cycle, in combination with capecitabine.

2. How to take: Neratinib is a tablet. Patients need to take it with meals at about the same time every day. Swallow it whole and do not chew, crush or separate it. If you miss a dose, there is no need to make up for it, just continue taking the next dose as originally planned.

5. Medication Management

Since diarrhea is the most common side effect of neratinib, patients need to receive antidiarrheal prophylaxis, such as loperamide, 56 days before taking it. If diarrhea still occurs after prevention, antidiarrheal drugs, fluids and electrolytes should be supplemented according to the doctor's advice. If necessary, the dose of neratinib needs to be interrupted or adjusted.

6. Storage method

Neratinib should be stored in a dry, light-proof, sealed container in a temperature-controlled environment20°C to 25°C (68°F to 77°F). Within the allowed range, the temperature can fluctuate to 15°C to 30°C (59°F to 86°F). Keep medicine away from children, pets, and places exposed to high temperatures, humidity, and direct sunlight.

7. Mechanism of action

Neratinib, as an intracellular kinase inhibitor, inhibits the growth and division of cancer cells by binding toHER2 receptor and blocking its signal transduction. This provides new treatment strategies for patients with HER2-positive breast cancer, helping to improve their quality of life and extend survival.

Before using neratinib, be sure to consult a professional doctor and follow your doctor's instructions. If you have any questions or discomfort, please seek medical advice promptly.