What is Nerlynx (neratinib)?
Nerlynx (neratinib) is indicated for adult patients with early-stage HER2 positive (human epidermal growth factor receptor 2 positive) overexpressed/amplified breast cancer, as an extended adjuvant treatment to follow previous adjuvant trastuzumab-based therapy[1,2].
How does Nerlynx (neratinib) work?
The HER2 proteins are receptors controlling the growth, multiplication, and reparation of cells.
In some cases, a genetic defect can lead to overproduction of the protein which results in the uncontrolled production of cancer cells, including cancerous breast cells[4,5].
Nerlynx (neratinib) is a kinase inhibitor, an agent that interferes with the activation of proteins. Neratinib, the active ingredient of Nerlynx, targets the HER2 protein on breast cancer cells to block the cancer from growing[2,3].
Where has Nerlynx (neratinib) been approved?
Nerlynx (neratinib) was approved for the treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy by:
- Food and Drug Administration (FDA), USA, on July 17, 2017
- European Medical Agency (EMA), European Union, on August 31, 2018.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Nerlynx (neratinib) taken?
The recommended dose of Nerlynx (neratinib) is[1,2]:
- 240 mg (6 tablets) taken once daily with food.
The treatment should be started within a year of finishing treatment with trastuzumab and should be taken continuously for one year.
Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability[1,2].
Complete information about Nerlynx (neratinib) dosage and administration can be found in the official prescribing information listed in our references section[1,2].
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects or adverse reactions of Nerlynx (neratinib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include[1,2]:
- abdominal pain
- stomatitis (sore, inflamed mouth).
Use in specific populations
Nerlynx (neratinib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information[1,2].
- Summary of Product Characteristics [FDA]: Nerlynx (neratinib)[PDF]
Puma Biotechnology, Inc., July 2017.
- Summary of Product Characteristics [EMA]: Nerlynx (neratinib)[PDF]
Puma Biotechnology, Ltd., August 2018.
3. Breastcancer.org, How Nerlynx Works, last update 20/07/2017, cited on 17/12/2018.
- Breastcancer.org, HER2 Status, cited on 17/12/2018
- National Cancer Institute, Definition of human epidermal growth factor receptor 2, cited on 18/12/2018