Breast Cancer Rx Gets New Indication

FDA approves Nerlynx (neratinib) for advanced breast cancer

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new indication for a breast cancer drug.

The medication is Nerlynx (neratinib). It is now approved to treat advanced breast cancer and be given with capecitabine.

Approved for adults, this medication is for those who have cancer that has spread and who have already tried two or more breast cancer treatments (anti-HER2).

This medication was initially approved in 2017 for early-stage HER2-positive breast cancer. This new approval is a new indication for the drug.

Neratinib, available in tablet form, is to be given in the following dose:

  • 240 mg (6 tablets) once a day with food
  • On days 1-21 of a 21-day cycle

Common side effects of neratinib plus capecitabine include back pain, constipation, decreased appetite, dizziness, fatigue, and nausea and vomiting.

This medication is associated with diarrhea. In some cases, it may be severe. Your health care provider may start you on an antidiarrheal medication with the first dose of Nerlynx.

If you notice weakness, dizziness or fever with diarrhea, contact your health care provider.

This medication can interact with many medications. Tell your health care provider about all of the medications you take. This includes prescription medications, over-the-counter drugs and herbal supplements.

Speak with your health care provider if you have any questions.