Other safety information
Reading time: 2 min
- 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:
|Co-administration with strong inducers
of the CYP3A4/Pgp isoform of cytochrome P450
- carbamazepine, phenytoin (antiepileptics)
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®.