Nerlynx

NERATINIB

Manufacturer: Puma Biotechnology, Inc.

Score: 141.0

Quick Summary

Nerlynx (NERATINIB) is a kinase inhibitor used for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer and in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer. The most common adverse reactions include 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. Dosing recommendations include 240 mg daily with food, and dose adjustments may be necessary for adverse reactions. Special population considerations include use during pregnancy, pediatric use, geriatric use, and patients with hepatic impairment.

Key Clinical Findings and Indications

Extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer
Treatment of adult patients with advanced or metastatic HER2-positive breast cancer in combination with capecitabine

Important Safety Information

Warning

Diarrhea, hepatotoxicity, and embryo-fetal toxicity are potential risks associated with Nerlynx

Contraindications

None

Adverse Reactions

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
Urinary tract infection

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for adverse reactions, including diarrhea and hepatotoxicity

Extended adjuvant treatment of early-stage HER2-positive breast cancer

Adult Dose

240 mg daily with food

Pediatric Dose

Not established

Advanced or metastatic HER2-positive breast cancer

Adult Dose

240 mg daily with food in combination with capecitabine

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Nerlynx can cause fetal harm when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

Not specified in the provided information

Pediatric Use

The safety and efficacy of Nerlynx in pediatric patients has not been established

Geriatric Use

No overall differences in effectiveness were observed between patients ≥65 years old and patients <65 years old
Higher frequency of treatment discontinuations due to adverse reactions in the ≥65 years age group

Similarity: 62.3%

TUKYSA

TUCATINIB

SEAGEN INC.

Similarity: 60.8%

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