• Resources to utilize in your practice and with your patients

    Downloadable materials

    Prescribing Information

    Review the Full Prescribing Information for NERLYNX.

    Download

    Enrollment Form

    Enrollment to the Puma Patient Lynx Support Program.

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    Dosing and Administration Guide

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

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    ExteNET Trial (eBC) Data

    Review a brochure describing the efficacy and safety data for NERLYNX in patients with early-stage HER2+ breast cancer and subgroups of clinical interest.

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    eBC Treatment Completion Data

    Review a brochure that includes data on patients with early-stage HER2+ breast cancer who completed treatment with Nerlynx as planned in the ExteNET trial.1,*
    Download

    eBC HR- Data

    Review a brochure that includes data on patients with early-stage HER2+ HR- breast cancer.

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    NALA Trial (mBC) Data

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

    Download
    • Completion of therapy defined as ≥11 months of neratinib therapy or neratinib therapy ended after <11 months due to disease recurrence.1
    • eBC: early-stage breast cancer; HR-: hormone receptor–negative; mBC: metastatic breast cancer.

    Download tools to facilitate your discussions with patients receiving Nerlynx

    Puma Patient Lynx Resources Brochure

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

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    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

    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 1-855-816-5421.

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

    Download

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

    Enrollment Form

    Enrollment to the Puma Patient Lynx Support Program.

    English
    Español

    Co-pay Card Program*

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

    Go to patient enrollment page
    • Limitations apply. Patient must have commercial insurance. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Puma Biotechnology reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, call 1-855-816-5421.
    Reference:
    1. Moy B, Takahashi M, Ohtani S, et al. Association between treatment duration and overall survival in early-stage HER2+ breast cancer patients receiving extended adjuvant therapy with neratinib in the ExteNET trial. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021.

    Important Safety Information

    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.

    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.

    Important Safety Information

    Warnings and Precautions:

  • Diarrhea: Manage diarrhea through either Nerlynx dose escalation or loperamide prophylaxis...

    • Warnings and Precautions:

    • 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 1-800-332-1088 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:

    • 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-3302 09/25