View by Tumor Type
Breast Cancer
Home › All Therapies › Nerlynx

Nerlynx

neratinib
Pan-HER TKI FDA Approved 2017 Puma Biotechnology
Route
Oral
Half-Life
14 hrs
FDA Approved
2017
Manufacturer
Puma Biotechnology
Navigation -->
1. Indications and Usage

Breast cancer: Extended adjuvant after trastuzumab for HER2+ early BC. With capecitabine for HER2+ mBC.

2. Dosage and Administration

240 mg daily with food. Loperamide prophylaxis required ×56 days.

3. Dosage Forms and Strengths

Tablets: 40 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Diarrhea: 95%. Loperamide required from Day 1.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (95%), Nausea (43%), Abdominal Pain (36%), Fatigue (27%), Vomiting (26%), Rash (18%), Stomatitis (14%), Decreased Appetite (12%)

Diarrhea
95%
Nausea
43%
Abdominal Pain
36%
Fatigue
27%
Vomiting
26%
Rash
18%
Stomatitis
14%
Decreased Appetite
12%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

PPIs: Avoid.
CYP3A4 Inhibitors/Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Irreversible pan-ErbB TKI reducing EGFR, HER2, HER4 autophosphorylation and downstream signaling.

Pharmacokinetics

Tmax: 2-8h. Protein binding: >99%. t½: 7-17h. Feces 97%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Nerlynx Trials on ClinicalTrials.gov ↗ 📚 PubMed: Nerlynx Clinical Trials ↗
FDA-Approved Tumor Types

Nerlynx has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Breast Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Nerlynx. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Nerlynx (neratinib) approved for?

Nerlynx (neratinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Nerlynx (neratinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Nerlynx (neratinib) work?

Irreversible pan-ErbB TKI reducing EGFR, HER2, HER4 autophosphorylation and downstream signaling.

What are the most common side effects?

Diarrhea (95%), Nausea (43%), Abdominal Pain (36%), Fatigue (27%), Vomiting (26%), Rash (18%), Stomatitis (14%), Decreased Appetite (12%) Diarrhea 95% Nausea 43% Abdominal Pain 36% Fatigue 27% Vomiting 26% Rash 18% Stomatitis 14% Decreased Appetite 12%

← All Therapies Full Prescribing Information ↗