FDA approves new treatment to reduce the risk of breast cancer returning - Drug Information Update

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The U.S. Food and Drug Administration approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

Common side effects of Nerlynx include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, swollen and sore mouth (stomatitis), decreased appetite, muscle spasms, indigestion (dyspepsia), liver damage (AST or ALT enzyme increase), nail disorder, dry skin, abdominal swelling (distention), weight loss and urinary tract infection.

Patients should be given loperamide for the first 56 days of treatment with Nerlynx and as needed thereafter to help manage diarrhea. Additional antidiarrheals, fluids and electrolytes should also be given as clinically indicated to help manage diarrhea. Patients who experience severe side effects, including diarrhea or liver damage (hepatoxicity), should stop taking Nerlynx. Women who are pregnant or breastfeeding should not take Nerlynx because it may cause harm to a developing fetus or a newborn baby.

For more information, please visit: Nerlynx.