Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION Diarrhea ...
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HIGHLIGHTS OF PRESCRIBING INFORMATION Diarrhea ...
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.
• •Dose interruptions and/or dose reductions are recommended based on individual safety and tolerability. (2.3) • Hepatic impairment: Reduce starting dose to 80 mg in patients with severe ... of potential risk to a fetus and to use effective contraception. (5.3, 8.1, 8.3)
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