Healthcare Professionals​

This is an international website for NERLYNX® dedicated to Healthcare professionals ​​

IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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This is an international website for NERLYNX® dedicated to Healthcare Professionals.

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Other safety information

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Contraindications5

  • Hypersensitivity to the active substance or to any of the excipients: mannitol (E421), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogrol, talc, iron oxide red (E172).
  • Severe hepatic impairment (Child-Pugh C).
  • Other medicines:
Contraindicated Examples
Co-administration with strong inducers
of the CYP3A4/Pgp isoform of cytochrome P450

 - carbamazepine, phenytoin (antiepileptics)
 - St John’s wort (Hypericum perforatum) (herbal product)
 - rifampicin (antimycobacterial)

Pregnancy, contraception & breast-feeding5

  • There are no data from the use of NERLYNX in pregnant women, therefore, NERLYNX should not be used during pregnancy unless the clinical condition of the woman requires treatment with neratinib. If neratinib is used during pregnancy, or if the patient becomes pregnant while taking NERLYNX, the patient should be informed of the potential hazard to the foetus.
  • Women of child-bearing potential must use highly effective contraceptive measures while taking NERLYNX and for 1 month after stopping treatment. It is currently unknown whether neratinib may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a barrier method. Men should use a barrier method of contraception during treatment and for 3 months after stopping treatment.
  • It is not known whether NERLYNX is excreted in human milk. A risk to the breast-fed infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or NERLYNX.

 See drug-drug interactions

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Il est donc nécessaire de bien baliser les titres. Nous conseillons d'utiliser un H2 ou un H3 (pas de H1).

Drug-drug interactions5

Medications Considerations Examples*
Proton pump inhibitors, H2-receptor antagonists and antacids Co-administration with proton pump inhibitors (PPIs) is not recommended.If H2-receptor antagonists are used: NERLYNX should be taken at least 2 hours before or 10 hours after the intake of the H2-receptor antagonist. If antacids are taken: separate the dosing of NERLYNX and the antacid by at least 3 hours. omeprazole, lansoprazole, dexpansoprazole, rabeprazole, pantoprazole; nizatidine, famotidine, cimetidine or ranitidine
Strong or moderate CYP3A4/P-gp inhibitors Concomitant treatment is not recommended due to risk of increased exposure to NERLYNX. If the inhibitor cannot be avoided, reduce NERLYNX dose. atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, lopinavir, ketoconazole, itraconazole, clarithromycin, troleandomycin, voriconazole, cobicistat, ciprofloxacin, cyclosporin, diltiazem, fluconazole, erythromycin, fluvoxamine or verapamil
Moderate CYP3A4/P-gp inducers Concurrent use of NERLYNX with moderate CYP3A4/P-gp is not recommended as it may lead to loss of efficacy. bosentan, efavirenz, etravirine, phenobarbital, primidone or dexamethasone
Strong CYP3A4/ P-gp inducers Concurrent use with NERLYNX is contraindicated. phenytoin, carbamazepine, rifampicin, or herbal preparations containing St John’s Wort (Hypericum perforatum)
Breast cancer resistance protein efflux transporters NERLYNX may inhibit breast cancer resistance protein (BCRP) intestinal level as suggested by in vitro studies. Clinical studies with BCRP substrates have not been conducted. Patients who are treated with BCRP substrates should be monitored carefully. rosuvastatin, sulfasalazineor irinotecan
P-glycoprotein efflux transporters In in-vitro studies, NERLYNX is an inhibitor of P-glycoprotein (P-gp) efflux transporters. This might be clinically relevant for patients who are treated concomitantly with therapeutic agents with a narrow therapeutic window whose absorption involves P-gp transporters in the gastrointestinal tract. These patients should be carefully monitored. digoxin, colchicine, dabigatran, phenytoin, statins, cyclosporine, everolimus, sirolimus or tacrolimus

*This list includes some but not all therapeutic compounds with potential interaction with neratinib. For an in depth evaluation, please consult drug-drug interaction search tools.