Neratinib (Specialist drug)

SOURCE: US FDA prescribing information only (Nerlynx, Puma Biotechnology Inc., label date 2026-07-02, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=55a7b5be-747b-8497-e063-6294a90a8923). NO UK SPC was fetched in this bundle — the eMC provider is null — so this is US labelling and must be verified against a UK SPC before use. EXTENDED ADJUVANT TREATMENT OF EARLY-STAGE BREAST CANCER (verbatim): 'The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily, with food, continuously until disease recurrence or for up to one year.' ADVANCED OR METASTATIC BREAST CANCER (verbatim): 'The recommended dose of NERLYNX is 240 mg (six tablets) 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.' MANDATORY DIARRHOEA MANAGEMENT — the label requires EITHER loperamide prophylaxis OR a two-week dose escalation. When NOT using dose escalation, initiate loperamide with the first dose of neratinib and continue antidiarrhoeal prophylaxis during the first 56 days of treatment, per the label's Table 1: weeks 1 to 2 (days 1 to 14) loperamide 4 mg three times daily; weeks 3 to 8 (days 15 to 56) loperamide 4 mg twice daily; from week 9 to discontinuation, loperamide 4 mg as needed, not to exceed 16 mg per day, titrated to achieve 1 to 2 bowel movements per day. After day 56, use loperamide to maintain 1 to 2 bowel movements per day. If diarrhoea occurs despite prophylaxis, treat with additional antidiarrhoeals, fluids and electrolytes as clinically indicated; dose interruptions and reductions may also be required. TWO-WEEK DOSE ESCALATION (alternative to starting at 240 mg, for early-stage and metastatic breast cancer, per the label's Table 2): week 1 (days 1 to 7) 120 mg daily (three 40 mg tablets); week 2 (days 8 to 14) 160 mg daily (four 40 mg tablets); week 3 and onwards 240 mg daily (six 40 mg tablets, the recommended dose). ADMINISTRATION: take at approximately the same time every day; if a dose is missed, do not replace it — resume with the next scheduled daily dose. DISCONTINUE for adverse reactions that fail to recover to Grade 0 to 1 or baseline, for toxicities resulting in a treatment delay of more than 3 weeks, or if unable to tolerate 120 mg daily. HEPATOTOXICITY MODIFICATION: for Grade 3 ALT or AST (5 to 20 x ULN) or Grade 3 bilirubin (above 3 to 10 x ULN), hold until recovery to Grade 1 or lower, evaluate alternative causes, and resume at the next lower dose level if recovery occurs within 3 weeks; if Grade 3 recurs despite one dose reduction, permanently discontinue. For Grade 4 ALT or AST (above 20 x ULN) or Grade 4 bilirubin (above 10 x ULN), permanently discontinue. OTHER TOXICITY: Grade 3 — hold until recovery to Grade 1 or lower or baseline within 3 weeks of stopping, then resume at the next lower dose level; Grade 4 — discontinue permanently. Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. HEPATIC IMPAIRMENT: reduce the starting dose to 80 mg in patients with SEVERE hepatic impairment. When used in combination with capecitabine, refer to the capecitabine prescribing information for capecitabine dose modifications. PAEDIATRIC: 'The safety and efficacy of NERLYNX in pediatric patients has not been established.' No paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. No renal dose adjustment appears in the fetched sections. The label's dose-modification tables, pregnancy, warnings and interactions sections were truncated at the source-fetch limit.