NERATINIB FDA LABEL

 

Introduction:

We at [Company Name] aim to provide our readers with comprehensive and up-to-date information about the drug Neratinib. In this article, we will be discussing the FDA label for Neratinib, including its approved indications, dosage and administration, warnings and precautions, adverse reactions, and other important information.

What is Neratinib?

Neratinib, also known by its brand name Nerlynx, is an oral tyrosine kinase inhibitor used in the treatment of HER2-positive breast cancer that has already been treated with other HER2-targeted therapies. It is taken orally, usually once daily, with food, and is available in tablet form.

FDA Label for Neratinib:

Approved Indications:

Neratinib is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. The FDA also approved Neratinib for the treatment of metastatic HER2-overexpressed/amplified breast cancer, in patients who have previously been treated with at least two other HER2-targeted therapies.

Dosage and Administration:

The recommended dosage of Neratinib is 240 mg (six 40 mg tablets) taken orally, once daily, with food, for a period of one year. It is important to take Neratinib at the same time every day to maintain consistent levels of the drug in the body.

Warnings and Precautions:

Neratinib can cause severe diarrhea, which can lead to dehydration and electrolyte imbalance. Patients should be closely monitored for diarrhea and advised to take anti-diarrheal medication at the first sign of loose stools. Neratinib can also cause liver damage, so liver function tests should be performed before starting treatment and regularly during treatment.

Adverse Reactions:

The most common adverse reactions associated with Neratinib include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, decreased appetite, stomatitis, dyspepsia, and nail disorders.

Conclusion:

In conclusion, Neratinib is an oral tyrosine kinase inhibitor used in the treatment of HER2-positive breast cancer. Its FDA label includes important information about its approved indications, dosage and administration, warnings and precautions, and adverse reactions. As with any medication, it is important to follow the dosing and administration instructions closely and to be aware of potential adverse reactions. If you have any questions or concerns about Neratinib or any other medication, please consult with your healthcare provider.