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.

Programs to help support your patients

Use the following resources to get your eligible patients started on Nerlynx

Enrollment Form

English

Español

Sample letter of medical
necessity

Download

The Nerlynx patient co-pay card is available

Puma Biotechnology offers co-pay assistance to help qualified commercially insured patients with the cost of their Nerlynx prescription

Nerlynx co-pay card

Eligible commercially insured patients treated with Nerlynx may pay as little as $10 per prescription.* Patients can 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

National Drug Code (NDC) for Nerlynx 40 mg film-coated tablets

Package size	NDC
133 tablets	NDC 70437-240-33
180 tablets	NDC 70437-240-18

Use the 133-tablet NDC for the first month of treatment when initiating dose escalation for Nerlynx.

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.

Support for patients prescribed Nerlynx

Access & coverage

Benefits Verification & Prior Authorization Assistance

This program provides comprehensive support, including benefits investigation to verify insurance coverage and assistance with prior authorization.

Nerlynx Quick Start

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

Co-Pay Assistance

Eligible commercially insured patients treated with NERLYNX may pay as little as $10 per prescription. Patients can be enrolled through their specialty pharmacy or through the Access and Support page on nerlynx.com.

Financial Support Information

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

Ongoing Treatment

Nerlynx Mentor Program

Patient mentors provide confidential support for patients who are considering or currently taking NERLYNX.*

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.

Nurse Call Center

Our staff of registered nurses by training are available to speak with patients and healthcare providers to answer questions about NERLYNX.^† The call center is open Monday to Friday, 9 AM to 6 PM ET, for your convenience. Call 1-855-816-5421 (when prompted, press 2). Bilingual nurses are available.

Mentors are compensated for their time.

This is an informational service. Call center nurses do not offer medical advice.

Specialty distributors

Current as of August 2022

Cardinal Health™ Specialty SolutionsT: (866) 677-4844www.cardinalhealth.com

McKesson Plasma and BiologicsT: (877) 625-2566www.mckesson.com/plasmabiologics

McKesson Specialty HealthT: (800) 482-6700www.mckessonspecialtyhealth.com

ASD HealthcareT: (800) 746-6273www.asdhealthcare.com

Specialty pharmacy network

Current as of August 2022

AcariaHealth™T: (800) 511-5144 F: (877) 541-1503www.acariahealth.comHours of operation: M-F, 8 am-10 pm (ET)
Biologics, Inc.T: (800) 850-4306 F: (800) 823-4506www.biologicsinc.comHours of operation: M-F, 8 am-8 pm (ET)

Optum^® Specialty PharmacyT: (877) 445-6874 F: (877) 342-4596specialty.optumrx.comHours of operation: M-F, 8 am-10 pm (ET); Sat., 9 am-8 pm (ET)
Accredo^® Health Group, Inc.T: (877) 732-3431 F: (866) 352-3973www.accredo.comHours of operation: M-F, 8 am-8 pm (ET)
CVS Specialty PharmacyT: (844) 239-4761 F: (855) 296-0210www.cvsspecialty.comHours of operation: M-F, 8:30 am-8:30 pm (ET)

Onco360 Oncology PharmacyT: (877) 662-6633 F: (877) 662-6355www.onco360.comHours of operation: M-F, 8 am-7 pm (ET); Sat., 9 am-2 pm (ET)

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

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 1-800-332-1088 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:

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.