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Study Design Study Results Safety Dosing NCCN Guidelines®

EARLY-STAGE SAFETY INFORMATION
Early-Stage Safety Information

Safety is predictable with NERLYNX3

MOST COMMON ADVERSE REACTIONS (≥5%) IN THE ExteNET TRIAL3

Most common AEs Most common AEs

There was no evidence of cardiac or serious pulmonary toxicity nor increased risk for secondary malignancy observed in ExteNET2,21

*Includes abdominal pain, abdominal pain upper, and abdominal pain lower.

†Includes rash, rash erythematous, rash follicular, rash generalized, rash pruritic, rash pustular, rash maculo-papular, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption.

‡Includes stomatitis, aphthous stomatitis, mouth ulceration, oral mucosal blistering, mucosal inflammation, oropharyngeal pain, oral pain, glossodynia, glossitis, and cheilitis.

§Includes nail disorder, paronychia, onychoclasis, nail discoloration, nail toxicity, nail growth abnormal, and nail dystrophy.

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 dosing strategies
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.
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  21. Puma Biotechnology, Inc. Data on file
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