Transcription of Full Prescribing Information - NERLYNX
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Full Prescribing Information - NERLYNX
HIGHLIGHTS OF Prescribing Information These highlights do not include all the Information needed to use NERLYNX safely and effectively. See full Prescribing Information for NERLYNX . NERLYNX (neratinib) tablets, for oral use Initial Approval: 2017 _____ INDICATIONS AND USAGE _____ NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. (1, 14) _____ DOSAGE AND ADMINISTRATION _____ Antidiarrheal prophylaxis: Initiate loperamide with the first dose of NERLYNX and continue during first 2 cycles (56 days) of treatment. Instruct patients to maintain 1-2 bowel movements per day and on how to use antidiarrheal treatment regimens. ( ) Recommended dose: 240 mg (6 tablets) given orally once daily with food, continuously for one year. ( ) Dose interruptions and/or dose reductions are recommended based on individual safety and tolerability.
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage
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