Piqray is indicated in postmenopausal women. It is not to be used in women who are, or may be, pregnant or breast-feeding (see Indications/Uses).
Women of childbearing potential/Contraception in males and females: Females of reproductive potential should be advised that animal studies and the mechanism of action have shown that alpelisib can be harmful to the developing foetus. Embryo-foetal development studies in rats and rabbits have demonstrated that oral administration of alpelisib during organogenesis induced embryotoxicity, foetotoxicity and teratogenicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
In case females of reproductive potential take Piqray, they should use effective contraception (e.g. double-barrier method) when taking Piqray and for at least 1 week after stopping treatment with Piqray.
Male patients with sexual partners who are pregnant, possibly pregnant or who could become pregnant should use condoms during sexual intercourse while taking Piqray and for at least 1 week after stopping treatment with Piqray.
Please refer to Use in Pregnancy & Lactation of the prescribing information for fulvestrant.
Pregnancy: Piqray is not indicated and is not to be used in women who are, or may be, pregnant (see Indications/Uses).
There are no data from the use of alpelisib in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Piqray is not recommended during pregnancy and in women of childbearing potential not using contraception.
The pregnancy status of females of reproductive potential should be verified prior to starting treatment with Piqray.
Breast-feeding: It is not known if alpelisib is excreted in human or animal milk.
Because of the potential for serious adverse reactions in the breast-fed infant, it is recommended that women should not breast-feed during treatment and for at least 1 week after the last dose of Piqray.
Fertility: There are no data on the effects of alpelisib on fertility. Based on repeated dose toxicity studies in animals, alpelisib may impair fertility in males and females of reproductive potential (see Pharmacology: Toxicology: Preclinical safety data under Actions).