• Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
  • Resources to utilize in your practice and with your patients

    Downloadable materials

    Prescribing Information

    Review the Full Prescribing Information for Nerlynx.

    Enrollment Form

    Prescribe Nerlynx to your appropriate patients with the Enrollment Form.

    NALA Trial (mBC) Brochure

    Review a brochure describing the efficacy and safety data for Nerlynx + capecitabine in patients with metastatic HER2+ breast cancer.

    Dosing and Administration Guide

    Review detailed information for your office staff about dosing, dose escalation, and treatment management.

    • mBC: metastatic breast cancer.

    Puma Patient Lynx offers a variety of support and financial assistance programs for your patients

    Enrollment Form

    Prescribe Nerlynx to your appropriate patients with the Enrollment Form.

    Co-pay Card Program

    Eligible commercially insured patients treated with NERLYNX can be enrolled for co-pay assistance.

    Go to patient enrollment page

    Support for patients prescribed NERLYNX*

    • Access and coverage
    • Ongoing patient support

    Puma Patient Lynx programs are subject to change or to be discontinued without notice. Limitations apply and certain programs are subject to eligibility criteria. For full terms and conditions, call 1-855-816-5241.

    Download the Nerlynx Dosing and Administration Guide for additional information to help your patients get started with Nerlynx

    Download

    Resources for your patients

    Share important resources, such as the Mentor Program, with your patients to provide them support throughout their treatment.

    See what's available

    Download tools to facilitate your discussions with patients receiving Nerlynx

    HUB Resources Brochure

    Review a brochure describing the upgraded patient support services available from Puma Patient Lynx.

    Download

    Important Safety Information and Indications

    Contraindications: None

    Warnings and Precautions:

    • Diarrhea: Manage diarrhea through either Nerlynx dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold Nerlynx in patients experiencing severe and/or persistent diarrhea. Permanently discontinue Nerlynx in patients experiencing Grade 4 diarrhea or Grade ≥2 diarrhea that occurs after maximal dose reduction.
    • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold Nerlynx in patients experiencing Grade 3 liver abnormalities and permanently discontinue Nerlynx in patients experiencing Grade 4 liver abnormalities.
    • Embryo-Fetal Toxicity: Nerlynx can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

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

    • Nerlynx as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
    • Nerlynx in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

    To report suspected adverse reactions, contact Puma Biotechnology, Inc. at 1-844-Nerlynx (1-844-637-5969) or FDA at 1-844-332-1088 or www.fda.gov/medwatch.

    Drug Interactions:

    • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate Nerlynx by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate Nerlynx by at least 3 hours after antacids.
    • Strong CYP3A4 inhibitors: Avoid concomitant use.
    • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
    • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
    • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with Nerlynx.

    Use In Specific Populations:

    • Lactation: Advise women not to breastfeed.

    Please see Full Prescribing Information.

    Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

    • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
    • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.
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    Nerlynx is a registered trademark and Puma Patient Lynx is a trademark of Puma Biotechnology, Inc.
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    PRC-US-NER-2371 07/22