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Access and support
Access and Support

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Support for patients prescribed NERLYNX
Enrollment Form
Spanish/Español
NERLYNX Co-pay Card
ACCESS AND REIMBURSEMENT

  • Benefits Verification and Prior Authorization Assistance

    Our Nurse Case Manager will conduct a benefits investigation, verify insurance approval or coverage, and obtain and submit necessary documentation for patients requiring prior authorization.

  • NERLYNX Quick Start

    Puma Biotechnology provides a free 3-week supply of NERLYNX to eligible patients experiencing delays in gaining access to therapy.

  • Co-Pay Assistance

    Puma Biotechnology offers co-pay assistance to help qualified insured patients with the out-of-pocket costs associated with their NERLYNX prescription.

  • Financial Support

    For patients with financial needs, we will work to find appropriate sources for support.

ONGOING TREATMENT SUPPORT

  • NERLYNX Mentor Program

    This program is available to all patients with HER2+ breast cancer who are considering or currently taking NERLYNX.

  • Nurse Support

    Our nurses are available to speak with patients and healthcare providers to answer questions about NERLYNX. The call center is open Monday through Friday, 9 AM - 8 PM EST.

  • Product Support

    Our specialty pharmacy network will provide patients with product education and side-effect counseling to help them better understand and manage their NERLYNX therapy.

  • Text Message Support

    Patients can sign up to receive medication reminders and motivational messages to support treatment adherence.

Supportive Care Voucher Program

  • Up to 3 months’ free supply per antidiarrheal product

  • Available to all patients

  • Used at the dispensing pharmacy, with prescription(s) at local retail pharmacy, or through Puma Specialty Pharmacy network

For more information on the Puma Patient Lynx Support Program, call 1-855-816-5421.
How to get NERLYNX
NERLYNX is available through specific specialty pharmacies. To learn about reimbursement, download the form below.
Enrollment Form
Spanish/Español
Sample Letter of Medical Necessity
  • AcariaHealth™
    T: (800) 511-5144 F: (877) 541-1503
    Hours of operation:
    M-F, 8 am–10 pm (ET)
  • Biologics, Inc.
    T: (800) 850-4306 F: (800) 823-4506
    www.biologicsinc.com
    Hours of operation:
    M-F, 8 am–8 pm (ET)
  • Optum® Specialty Pharmacy
    T: (855) 427-4682 F: (800) 491-7997
    Hours of operation:
    Every day, 7 am–10 pm (CST)
  • Accredo® Health Group, Inc.
    T: (877) 732-3431 F: (866) 352-3973
    Hours of operation:
    M-F, 8 am–11 pm (ET)
  • CVS Caremark Specialty Pharmacy
    T: (844) 239-4761 F: (855) 296-0210
    Hours of operation:
    M-F, 8:30 am–8:30 pm (ET)
  • Onco360®
    T: (877) 662-6633 F: (877) 662-6355
    Hours of operation:
    M-F, 8 am–7 pm (ET); Sat., 9 am–2 pm (ET)

National Drug Code (NDC)

NERLYNX 40 mg film-coated tablets
Package Size: 180 tablets
NDC: 70437-240-18

The NERLYNX patient co-pay card is available
Puma Biotechnology offers co-pay assistance to help qualified insured patients with the out-of-pocket costs associated with their NERLYNX prescription.
NERLYNX Co-pay Card
Commercially insured, eligible patients treated with NERLYNX may pay as little as $10 per prescription.* Patients will be enrolled through their specialty pharmacy. To verify your patients' eligibility or to enroll them in the co-pay card program, visit this website or call Puma Patient Lynx at 1-855-816-5421.
*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.

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:

  1. Chan A, Moy B, Mansi J, et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Br Cancer. 2020; In press.
  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 [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.
  5. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32(33):3744-3752.
  6. Yee D. Pathological complete response predicts event-free and distant disease free survival in the I-SPY 2 TRIAL. Slides presented at: 2017 San Antonio Breast Cancer Symposium (SABCS); December 5-9, 2017; San Antonio, TX.
  7. Recurrent breast cancer. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/ recurrent-breast-cancer/symptoms-causes/syc-20377135. Accessed July 27, 2020.
  8. Sun L, Zhu Y, Qian Q, Tang L. Body mass index and prognosis of breast cancer: an analysis by menstruation status when breast cancer diagnosis. Medicine (Baltimore). 2018;97(26):e11220.
  9. Pierce JP, Patterson RE, Senger CM, et al. Lifetime cigarette smoking and breast cancer prognosis in the After Breast Cancer Pooling Project. J Natl Cancer Inst. 2014;106(1):djt359.
  10. Helwick C. Final analysis of BCIRG-006 supports use of non–anthracycline-containing regimen in treatment of women with early breast cancer. The ASCO Post website. https://www .ascopost.com/issues/march-10-2016/final-analysis-of-bcirg-006-supports-use-of-nonanthracycline-containing-regimen-in-treatment-of-women-with-early-breast-cancer. Accessed July 27, 2020.
  11. von Minckwitz G, Huang C-S, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617-628.
  12. Singh JC, Jhaveri K, Esteva FJ. HER2-positive advanced breast cancer: optimizing patient outcomes and opportunities for drug development. Br J Cancer. 2014;111(10):1888-1898.
  13. Brufsky AM, Mayer M, Rugo HS, et al. Central nervous system metastases in patients with HER2-positive metastatic breast cancer: incidence, treatment, and survival in patients from registHER. Clin Cancer Res. 2011;17(14):4834-4843.
  14. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283.
  15. Untch M, Geyer CE Jr, Huang C-S, et al. Peripheral neuropathy (PN), thrombocytopenia (TCP) and central nervous system (CNS) recurrence: an update of the phase III KATHERINE trial of post-neoadjuvant trastuzumab emtansine (T-DM1) or trastuzumab (H) in patients (pts) with residual invasive HER2-positive breast cancer (BC). Slides presented at: 2019 European Society for Medical Oncology (ESMO) Congress; September 30, 2019; Barcelona, Spain.
  16. Chien J. HER2+ early breast cancer: balancing risk and toxicity. Slides presented at: 2019 San Antonio Breast Cancer Symposium (SABCS); December 11, 2019; San Antonio, TX.
  17. Lin NU. Breast cancer brain metastases: new directions in systemic therapy. Ecancermedicalscience. 2013;7:307.
  18. Lin NU, Winer EP. Brain metastases: the HER2 paradigm. Clin Cancer Res. 2007;13(6):1648-1655.
  19. Olson EM, Najita JS, Sohl J, et al. Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era. Breast. 2013;22(4):525-531.
  20. Hegedüs C, Truta-Feles K, Antalffy G, et al. Interaction of the EGFR inhibitors gefitinib, vandetanib, pelitinib and neratinib with the ABCG2 multidrug transporter: implications for the emergence and reversal of cancer drug resistance. Biochem Pharmacol. 2012;84(3):260-267.
  21. Puma Biotechnology, Inc. Data on file
  22. Barcenas CH, Hurvitz SA, Di Palma JA, et al. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. Published online May 25, 2020. doi:10.1016/j.annonc.2020.05.012.
  23. Puma Biotechnology. FDA ODAC Sponsor Presentation. May 24, 2017.
  24. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf. Accessed August 7, 2020.
  25. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed July 24, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.
  26. Saura C, Oliveira M, Feng Y-H, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥2 HER2- directed regimens: phase III NALA trial. J Clin Oncol. Published online July 17, 2020. doi:10.1200/JCO.20.00147
  27. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed July 24, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.
  28. Freedman RA, Gelman RS, Anders CK, et al. TBCRC 022: a phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol. 2019;37(13):1081-1089.
  29. Awada A, Colomer R, Inoue K, et al. Neratinib plus paclitaxel vs trastuzumab plus paclitaxel in previously untreated metastatic ERBB2-positive breast cancer: the NEfERT-T randomized clinical trial. JAMA Oncol. 2016;2(12):1557-1564.
  30. Rabindran SK, Discafani CM, Rosfjord EC, et al. Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res. 2004;64(11):3958-3965.
  31. Wissner A, Mansour TS. The development of HKI-272 and related compounds for the treatment of cancer. Arch Pharm (Weinheim). 2008;341(8):465-477.
  32. Canonici A, Gijsen M, Mullooly M, et al. Neratinib overcomes trastuzumab resistance in HER2 amplified breast cancer. Oncotarget. 2013;4(10):1592-1605.
  33. Segovia-Mendoza M, González-González ME, Barrera D, Díaz L, García-Becerra R. Efficacy and mechanism of action of the tyrosine kinase inhibitors gefitinib, lapatinib and neratinib in the treatment of HER2-positive breast cancer: preclinical and clinical evidence. Am J Cancer Res. 2015;5(9):2531-2561.
  34. Martin TA, Alani AS, Connors FA, et al. Neratinib as a putative therapy in metastatic brain disease. Poster presented at: 2017 San Antonio Breast Cancer Symposium (SABCS); December 5-9, 2017; San Antonio, TX.
  35. Zhao X-Q, Xie J-D, Chen X-G, et al. Neratinib reverses ATP-binding cassette B1-mediated chemotherapeutic drug resistance in vitro, in vivo, and ex vivo. Mol Pharmacol. 2012;82(1):47-58.
  36. Collins DM, Conlon NT, Kannan S, et al. Preclinical characteristics of the irreversible pan-HER kinase inhibitor neratinib compared with lapatinib: implications for the treatment of HER2-positive and HER2-mutated breast cancer. Cancers (Basel). 2019;11(6):737.
  37. Prat A, Baselga J. The role of hormonal therapy in the management of hormonal-receptor-positive breast cancer with co-expression of HER2. Nat Clin Pract Oncol. 2008;5(9):531-54238.
  38. Pohlmann PR, Mayer IA, Mernaugh R. Resistance to trastuzumab in breast cancer. Clin Cancer Res. 2009;15(24):7479-7491.
  39. Giuliano M, Trivedi MV, Schiff R. Bidirectional crosstalk between the estrogen receptor and human epidermal growth factor receptor 2 signaling pathways in breast cancer: molecular basis and clinical implication. Breast Care. 2013;8:256-262.
  40. Chung A, Cui X, Audeh W, Giuliano A. Current status of anti-human epidermal growth factor receptor 2 therapies: predicting and overcoming herceptin resistance. Clin Breast Cancer. 2013;13(4):223-232.
  41. Paplomata E, Nahta R, O'Regan RM. Systemic therapy for early-stage HER2-positive breast cancers: time for a less-is-more approach? Cancer. 2015;121(4):517-526.
  42. Arpino G, Wiechmann L, Osborne CK, Schiff R. Crosstalk between the estrogen receptor and the HER tyrosine kinase receptor family: molecular mechanism and clinical implications for endocrine therapy resistance. Endocr Rev. 2008;29(2):217-233.
  43. Loi S, Dafni U, Karlis D, et al. Effects of estrogen receptor and human epidermal growth factor receptor-2 levels on the efficacy of trastuzumab: a secondary analysis of the HERA trial. JAMA Oncol. 2016:2(8):1040-1047.

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