neratinib maleate at a glance
Medicine class
Irreversible pan-ERBB tyrosine kinase inhibitor
Treatment setting
Extended adjuvant treatment after trastuzumab-based therapy
Administration
Swallow the tablets whole with water and food; morning administration is preferred
Key practical risk
Diarrhoea is very common and can cause dehydration; preventive treatment and early management are important
What is neratinib maleate used for?
UK-licensed use:
Extended adjuvant treatment of adults with early-stage, hormone receptor-positive, HER2-overexpressed or amplified breast cancer who completed adjuvant trastuzumab-based therapy less than one year previously.
How does neratinib maleate work?
Neratinib binds irreversibly to the kinase regions of EGFR, HER2 and HER4. This reduces MAPK and AKT growth signalling, helping to limit the division and survival of HER2-driven cancer cells.
neratinib maleate preparations and strengths
Tablet
Route: Oral
Strengths: 40 mg
How to take neratinib maleate
Take neratinib exactly as directed by the oncology team.
Swallow tablets whole with water; do not crush or dissolve them.
Take with food, preferably in the morning.
Follow the prescribed preventive anti-diarrhoeal plan and contact the team early if diarrhoea develops.
Keep the bottle tightly closed to protect the tablets from moisture; leave the desiccant inside and do not swallow it.
neratinib maleate side effects
Common or expected effects
- Diarrhoea
- Nausea or vomiting
- Abdominal pain
- Reduced appetite
- Mouth inflammation or ulcers
- Rash
- Muscle spasms
- Fatigue
Get urgent medical advice
- Persistent or severe diarrhoea, dehydration, dizziness or fainting
- Yellow skin or eyes, dark urine, pale stools or marked upper abdominal pain
- Kidney failure or a substantial deterioration in kidney function
neratinib maleate in pregnancy
Neratinib may harm an unborn baby and should generally be avoided during pregnancy unless specialist assessment finds treatment necessary. Effective contraception is required during treatment and afterwards; people using systemic hormonal contraception should add a barrier method. Contact the oncology team promptly if pregnancy occurs.
neratinib maleate while breastfeeding
It is unknown whether neratinib enters human milk, and risk to a breastfed child cannot be excluded. The specialist team should decide with the patient whether breastfeeding or neratinib treatment should be discontinued.
neratinib maleate interactions
Check all prescription, non-prescription and herbal products with the oncology pharmacist. Important examples include:
Strong CYP3A4/P-gp inducers, including carbamazepine, phenytoin, rifampicin and St John’s wort
These can markedly reduce neratinib exposure and are contraindicated.
Strong or moderate CYP3A4/P-gp inhibitors, including clarithromycin, azole antifungals, ritonavir, verapamil and diltiazem
These may increase neratinib exposure and toxicity; concurrent use is not recommended unless specialist management is possible.
Proton-pump inhibitors, including omeprazole and lansoprazole
Reduced stomach acidity can lower neratinib absorption, so concurrent use is not recommended.
Common questions about neratinib maleate
Answers are fully visible for fast scanning and source review.
What type of breast cancer is neratinib maleate licensed for?
It is licensed for defined adults with early-stage, hormone receptor-positive, HER2-overexpressed or amplified breast cancer following adjuvant trastuzumab-based therapy.
Is neratinib maleate chemotherapy?
It is a targeted anticancer treatment called a tyrosine kinase inhibitor, rather than conventional cytotoxic chemotherapy.
Why is neratinib maleate given after trastuzumab?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.