Comprehensive Guide to Nerlynx Prescribing Information

Introduction

Nerlynx (neratinib) is a potent medication employed in the battle against early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, particularly post trastuzumab-based therapy. It's crucial that the initiation and supervision of Nerlynx treatment are managed by physicians with a background in cancer medication administration. This article delves into the prescribing information of Nerlynx, shedding light on its indications, dosage recommendations, and FDA approval based on clinical evaluations.

Indications

Nerlynx is primarily indicated as a monotherapy for the extended adjuvant treatment of adult patients diagnosed with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy [1].

Dosage and Administration

Nerlynx comes in tablet form with a unit strength of 40 mg. The standard dose is six tablets (240 mg) taken once daily, preferably in the morning with food [2]. In specific regimens, Nerlynx is administered orally once daily on Days 1--21 of a 21-day cycle alongside capecitabine, taken orally twice daily on Days 1--14 of the same cycle, continuing until either disease progression or unacceptable toxicities are observed [3].

FDA Approval for Metastatic HER2-Positive Breast Cancer

The FDA granted approval for neratinib in combination with capecitabine for treating adult patients with advanced or metastatic HER2-positive breast cancer, especially those who have undergone two or more prior anti-HER2 based regimens in a metastatic setting. The NALA clinical trial demonstrated the efficacy of neratinib with capecitabine, highlighting the progression-free survival and overall survival rates among patients. Common adverse reactions included diarrhea, nausea, vomiting, and decreased appetite, among others [4].

Bibliography

[1 ] European Medicines Agency. (n.d.). Nerlynx. Retrieved from [EMA Website](https://www.ema.europa.eu/en/medicines/human/EPAR/nerlynx)

[2] Nerlynx. (n.d.). Reducing Recurrence - NERLYNX. Retrieved from [Nerlynx Website](https://nerlynx.com)

[3] Nerlynx HCP. (n.d.). For healthcare professionals │ NERLYNX® (neratinib) tablets. Retrieved from [Nerlynx HCP Website](https://nerlynxhcp.com)

[4] Drugs.com. (n.d.). Nerlynx Dosage Guide. Retrieved from [Drugs.com Website](https://www.drugs.com)

[5] U.S. Food and Drug Administration. (2020, February 25). FDA approves neratinib for metastatic HER2-positive breast cancer. Retrieved from [FDA Website](https://www.fda.gov)