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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 ADVERSE REACTIONS (≥5%) IN THE NALA TRIAL3

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 + capecitabine26

*No Grade 4 diarrhea.26

†Renal impairment includes acute kidney injury, blood creatinine increased, renal failure, and renal impairment.

AE: adverse event.

DRUG INTERACTIONS3

  • 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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  3. NERLYNX [package insert]. Los Angeles, CA: Puma Biotechnology, Inc.
  4. Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389(10075):1195-1205.
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  21. Puma Biotechnology, Inc. Data on file
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