NERLYNX dose modifications for patients with diarrhea

Diarrhea management requires the correct use of antidiarrheal medication, dietary changes, and appropriate dose modifications of NERLYNX.

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Per CTCAE v4.03.

Complicated features include dehydration, fever, hypotension, renal failure, or Grade 3 or 4 neutropenia.

Despite being treated with optimal medical therapy.

Institute the following: Diet modifications, maintain ~2 L fluid intake per day, and once event resolves to Grade 1 or baseline, start loperamide 4 mg with each subsequent NERLYNX administration.

National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading for diarrhea8


Grade 1

Increase of < 4 stools per day over baseline; mild increase in
ostomy output compared to baseline

Grade 2

Increase of 4–6 stools per day over baseline; moderate
increase in ostomy output compared to baseline

Grade 3

Increase of ≥ 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self care ADL

Grade 4

Life-threatening consequences;
urgent intervention indicated

ADL: activities of daily living

DOSING AND ADMINISTRATION GUIDE
Learn about dose modifications, antidiarrheal prophylaxis, and drug interactions with NERLYNX.
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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, epistaxis, 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.