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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 Herceptin® (trastuzumab) to reduce the risk of recurrence.1 Nerlynx is also being studied in clinical trials in women with metastatic HER2+ breast cancer.2,3

Nerlynx 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 Nerlynx 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. Nerlynx 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

Nerlynx is also being evaluated in clinical trials in combination with other treatments for metastatic breast cancer. Early trial results suggest that Nerlynx may be beneficial in treating breast cancer patients with brain metastases or metastases to other organs.2,3

What are some of the possible side effects of Nerlynx?

Nerlynx 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 Nerlynx 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

Nerlynx 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

Things to know about Nerlynx

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

Nerlynx 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 Nerlynx and for at least one month after treatment has ended.1,4

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

Before beginning treatment with Nerlynx, 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 Nerlynx, 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

Dosing information

Nerlynx comes in a tablet form that should be taken by mouth. The recommended daily dose for Nerlynx is 240 mg (6 tablets), which should be taken with food. The dosage may be reduced, paused, or stopped if the patient experiences significant side effects.1

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

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

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.

  1. Nerlynx prescribing information. Puma Biotechnology, Inc. Available at Accessed 9/18/18.
  2. Welch A. Neratinib offers hope in treatment of CNS metastases in HER2+ breast cancer. OncLive. Available at Accessed 9/19/18.
  3. Harris J. Neratinib/T-DM1 combo shows promise in HER2-positive breast cancer. OncLive. Available at Accessed 9/19/18.
  4. Nerlynx product website. Puma Biotechnology, Inc. Available at Accessed 9/19/18.