Women of childbearing potential/Contraception in males and females: Women of childbearing age being treated with Ponatinib (Iclusig) should be advised not to become pregnant and men being treated with Ponatinib (Iclusig) should be advised not to father a child during treatment. An effective method of contraception should be used during treatment. It is unknown whether ponatinib affects the effectiveness of systemic hormonal contraceptives. An alternative or additional method of contraception should be used.
Pregnancy: There are no adequate data from the use of Ponatinib (Iclusig) in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Ponatinib (Iclusig) should be used during pregnancy only when clearly necessary. If it is used during pregnancy, the patient must be informed of the potential risk to the fetus.
Breast-feeding: It is unknown whether Ponatinib (Iclusig) is excreted in human milk. Available pharmacodynamic and toxicological data cannot exclude potential excretion in human milk. Breast-feeding should be stopped during treatment with Ponatinib (Iclusig).
Fertility: No human data on the effect of ponatinib on fertility are available. In rats, treatment with ponatinib has shown effects on female fertility and male fertility was not affected (see Pharmacology: Toxicology: Preclinical safety data under Actions). The clinical relevance of these findings to human fertility is unknown.