Dosing

Proactive diarrhea management

  • Proactive diarrhea management with loperamide and budesonide has been shown to lower the incidence and severity of diarrhea and reduce NERLYNX discontinuations due to treatment-related adverse events3

  • Diarrhea management should be started with the first dose of NERLYNX and continued through the end of the first month or as clinically necessary1

Anti-diarrheal administration

If diarrhea continues, simple dose reductions may help your patients stay on treatment longer.2,*

Supportive medications

Anti-diarrheal medication options

If the patient experiences breakthrough diarrhea, consider modifying, adding, or replacing one of the anti-diarrheals1

  • Diarrhea management should be started with the first dose of NERLYNX1

  • Medications that help manage diarrhea have different mechanisms of action; if one doesn't work, another might1,2

  • Dietary changes or NERLYNX dose modifications may also help manage side effects1

  MEDICATION   MECHANISM
Budesonide20,21
Anti-inflammatory
 
  • Glucocorticosteroid with substantial first-pass elimination

  • The formulation is enteric coated to protect dissolution in gastric juice, but dissolves at pH 5.5 to 7, ie, in the small intestine

Colestipol22 Bile acid sequestrant  
  • Colestipol hydrochloride binds bile acids in the intestine, forming a complex that is excreted in the feces

  • Constipation is the most common adverse reaction of colestipol treatment

  • Take colestipol ≥ 2 hours after or ≥ 4 hours before NERLYNX

       
Loperamide23
Anti-diarrheal
 
  • Opiate receptor agonist that binds to μ-opioid receptors in the large intestine

  • Inhibits the release of acetylcholine and prostaglandins, reducing propulsive peristalsis, and increasing intestinal transit time

  • Reduces daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes

Voucher program for a FREE 3-month supply of anti-diarrheals is available to eligible patients

In order to best support the patient's experience on NERLYNX, our service program has been expanded to include coverage of products used for anti-diarrheal prophylaxis.

This support can be accessed by your patient through a voucher, which can be obtained from your Puma sales representative or from one of the Puma network specialty pharmacies. The voucher can be used at any retail pharmacy to provide your patient a FREE 3-month supply of product(s) that you prescribe for anti-diarrheal treatment.

Qualifying guidelines and additional utilization instructions are provided in the voucher.

DOSING AND ADMINISTRATION GUIDE

View the full dosing and administration guide to learn more about dose modifications, anti-diarrheal prophylaxis, and drug interactions with NERLYNX.

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Select IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Lactation: Advise women not to breastfeed.

Please see additional IMPORTANT SAFETY INFORMATION below.

Learn about dose modifications

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com 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.