Active Ingredient: Neratinib
Neratinib 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.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 240 milligrams neratinib, once daily to meals.
When not using dose escalation, administer antidiarrheal prophylaxis during the first 56 days of treatment and initiate with the first dose of neratinib.
Instruct patients to take loperamide as directed in Table 1. Titrate loperamide to 1–2 bowel movements per day.
Table 1. Loperamide Prophylaxis:
| Time on neratinib | Loperamide Dose and Frequency |
|---|---|
| Weeks 1–2 (days 1–14) | 4 mg three times daily |
| Weeks 3–8 (days 15–56) | 4 mg twice daily |
| Weeks 9–Discontinuation of neratinib | 4 mg as needed, not to exceed 16 mg per day; titrate dosing to achieve 1–2 bowel movements per day |
If diarrhea occurs despite prophylaxis, treat with additional antidiarrheals, fluids and electrolytes as clinically indicated. neratinib dose interruptions and dose reductions may also be required to manage diarrhea.
The recommended dose of neratinib is 240 mg given orally once daily with food on Days 1–21 of a 21-day cycle plus capecitabine (750 mg/m² given orally twice daily) on Days 1–14 of a 21-day cycle until disease progression or unacceptable toxicities.
A two-week dose escalation for neratinib may be considered instead of starting at the 240 mg daily dose for patients with early-stage breast cancer and metastatic breast cancer, as described in Table 2.
Table 2. Neratinib Dose Escalation and Treatment Schedule:
| Time on neratinib | Neratinib Dose |
|---|---|
| Week 1 (days 1–7) | 120 mg daily |
| Week 2 (days 8–14) | 160 mg daily |
| Week 3 and onwards | 240 mg daily |
If diarrhea occurs, treat with antidiarrheal medications, fluids, and electrolytes as clinically indicated. Neratinib dose interruptions and dose reductions may also be required to manage diarrhea.
Instruct patients to take neratinib at approximately the same time every day.
If a patient misses a dose, do not replace missed dose, and instruct the patient to resume neratinib with the next scheduled daily dose.
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