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Study Design Study Results Safety Dosing NCCN Guidelines®

Metastatic Safety Information
Metastatic Safety Information

Safety is predictable with NERLYNX3

MOST COMMON AEs (≥5%) IN NALA3

Discontinuation of NERLYNX or lapatinib due to any AE occurred in 10.9% of patients treated with NERLYNX + capecitabine vs 14.5% of patients treated with lapatinib + capecitabine22

AE: adverse event.

*No Grade 4 diarrhea.

DRUG INTERACTIONS

  • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.
  • Strong CYP3A4 inhibitors: Avoid concomitant use.
  • Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.
  • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
Learn about dose reductions to help manage side effects

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

For Full Prescribing Information, please click here.

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Reference:

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  2. Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(12):1688-1700.
  3. NERLYNX (neratinib) tablets Prescribing Information, Puma Biotechnology, Inc. 04/20.
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  22. Puma Biotechnology, Inc. Data on file. 02/20.
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