What is Nerlynx® ? (neratinib)

Nerlynx is a targeted therapy that is approved for use in early-stage breast cancer that is positive for human epidermal growth factor receptor 2 (HER2+) after treatment with trastuzumab to reduce the risk of recurrence.1 Neratinib is also used in combination with another drug, capecitabine, for treating certain patients with advanced or metastatic HER2+ breast cancer that have previously been treated with at least two treatments for metastatic breast cancer that target HER2.2,3

Neratinib is manufactured by Puma Biotechnology.

What is the ingredient in Nerlynx?

The active ingredient in Nerlynx is neratinib, a kinase inhibitor that binds to the HER2 receptor, as well as the epidermal growth factor receptor (EGFR), and HER4 receptor.1

How does neratinib work?

Some breast cancers have an excess of the human epidermal growth factor receptor 2 (HER2), and these are classified as HER2-positive breast cancers (HER2+). Breast cancers that have an excess of HER2 receptors can grow and spread quickly, and blocking these receptors can slow or stop the growth of these cancers. Neratinib has demonstrated in clinical trials an increase in invasive disease-free survival (time without an invasive recurrence) in women with early-stage breast cancer.1

What are some of the possible side effects of neratinib?

Neratinib may cause serious side effects, including severe diarrhea, which may lead to dehydration. Diarrhea can be prevented or managed in most cases.1,4

The most common side effects experienced by patients taking neratinib as a single medication include1,4:

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Fatigue
  • Vomiting
  • Rash
  • Stomach upset
  • Decreased appetite
  • Mouth sores
  • Dry or inflamed mouth
  • Muscle spasms
  • Swelling of the stomach or abdomen
  • Changes to the nails, including color change
  • Dry skin
  • Decreased weight
  • Urinary tract infection

Neratinib may cause liver problems, and liver function tests (blood tests) should be routinely done to assess liver function. Liver damage can cause potential symptoms such as fatigue, nausea, vomiting, pain in the upper right portion of the stomach, fever, rash, itching, or a yellowing of the skin or eyes (jaundice).4

These are not all the possible side effects of neratinib. Patients should talk to their doctor about what to expect with treatment with neratinib.

Things to know about neratinib

Before starting treatment with neratinib, patients should talk to their doctor about all their health conditions, especially1,4:

Neratinib may cause harm to an unborn baby and should not be used by women who are pregnant. Women who can become pregnant should use effective birth control while taking neratinib and for at least one month after treatment has ended. Men who are taking neratinib and have female partners who are able to become pregnant should utilize effective contraception while taking neratinib and for three months after stopping treatment with neratinib (patients should discuss appropriate birth control methods with their doctor).1,4

It is not known if neratinib passes through breast milk. Women who are breastfeeding or plan to breastfeed should talk to their doctor before starting treatment with neratinib.1,4Women should not breastfeed while taking neratinib and for at least one month after treatment is finished.

Before beginning treatment with neratinib, patients should talk to their doctor about all their medications (prescription and over-the-counter), vitamins, and herbal supplements they are taking. Some medications or supplements may interfere with each other and may cause serious side effects.1

While taking neratinib, patients should avoid eating or drinking grapefruit products, as grapefruit products may increase the levels of neratinib in the body, which can increase the potential for side effects.1,4

Receiving neratinib

Neratinib comes in a tablet form that should be taken by mouth. Your healthcare provider will determine the appropriate neratinib dosing regimen and administration schedule for you. It is important to follow this schedule exactly as instructed, and not to stop taking neratinib or any accompanying medications on your own, unless you are instructed to do so by your healthcare provider.1

Because diarrhea is common and can be a serious side effect of neratinib, patients should generally be given a preventive anti-diarrhea medication when starting treatment.1

For more information, read the full prescribing information for neratinib.

Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their neratinib regimen.

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Written by: Editorial Team | Last reviewed: October 2020.