Women of childbearing potential/contraception in females: Women of childbearing potential should not become pregnant while on Lynparza and not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment and considered regularly throughout treatment.
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza therapy, during therapy and for 1 month after receiving the last dose of Lynparza, unless abstinence is the chosen method of contraception (see Precautions). Two highly effective and complementary forms of contraception are recommended.
Since it cannot be excluded that olaparib may reduce exposure to substrates of CYP2C9 through enzyme induction, the efficacy of some hormonal contraceptives may be reduced if co-administered with olaparib. Therefore, an additional non-hormonal contraceptive method should be considered during treatment (see Interactions). For women with hormone dependent cancer, two non-hormonal contraceptive methods should be considered.
Contraception in males: It is not known whether olaparib or its metabolites are found in seminal fluid. Male patients must use a condom during therapy and for 3 months after receiving the last dose of Lynparza when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients must also use highly effective contraception if they are of childbearing potential (see Precautions). Male patients should not donate sperm during therapy and for 3 months after receiving the last dose of Lynparza.
Pregnancy: Studies in animals have shown reproductive toxicity including serious teratogenic effects and effects on embryofoetal survival in the rat at maternal systemic exposures lower than those in humans at therapeutic doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no data from the use of olaparib in pregnant women, however, based on the mode of action of olaparib, Lynparza should not be used during pregnancy and in women of childbearing potential not using reliable contraception during therapy and for 1 month after receiving the last dose of Lynparza. (See Women of childbearing potential/contraception in females as previously mentioned for further information about birth control and pregnancy testing.)
Breast-feeding: There are no animal studies on the excretion of olaparib in breast milk. It is unknown whether olaparib or its metabolites are excreted in human milk. Lynparza is contraindicated during breast-feeding and for 1 month after receiving the last dose, given the pharmacologic property of the product (see Contraindications).
Fertility: There are no clinical data on fertility. In animal studies, no effect on conception was observed but there are adverse effects on embryofoetal survival (see Pharmacology: Toxicology: Preclinical safety data under Actions).