Cisplatin Pfizer Use In Pregnancy & Lactation

Effects on Fertility: Female: Based on non-clinical and clinical findings, female fertility may be compromised by treatment with cisplatin. Use of cisplatin has been associated with cumulative dose-dependent ovarian failure, premature menopause and reduced fertility. Non-clinical findings in mice treated with cisplatin (5 mg/kg intraperitoneally) showed that cisplatin caused direct damage to primordial follicle oocytes, leading to apoptosis, and ovarian depletion.
Male: Cisplatin can affect male fertility. Impairment of spermatogenesis and azoospermia have been reported (see Reproductive System and Breast Disorders under Adverse Reactions). Cisplatin caused testis damage and decreased sperm counts in mice, primarily through effects on differentiated spermatogonia. Although the impairment of spermatogenesis can be reversible, males undergoing cisplatin treatment should be warned about the possible adverse effects on male fertility.
Both men and women should seek advice on fertility preservation before treatment.
Use in Pregnancy: Category D.
The safety of cisplatin in pregnancy has not been established. Cisplatin can cross the placental barrier. In mice and rats, cisplatin is teratogenic and embryotoxic. Studies in rodents have shown that exposure during pregnancy can cause tumours in adult offspring. Cisplatin may be toxic to the fetal urogenital tract. Therefore cisplatin is considered to be potentially harmful to the fetus when administered to a pregnant woman and its use in pregnant women is not recommended. Patients should be advised to avoid becoming pregnant.
If the patient becomes pregnant whilst receiving the drug she should be advised of the hazard to the fetus. Cisplatin should only be used if the potential benefits outweigh the risk of therapy.
Women of childbearing potential should use effective contraception during treatment with cisplatin and for at least 26 weeks following the last dose. Men with female partners of childbearing potential should be advised to use effective contraception during treatment with cisplatin and for at least 14 weeks after the last dose.
For patients with end-stage renal disease, the washout period of cisplatin will be longer (up to 7 weeks); effective contraception for men is advised for at least 19 weeks and for female patients, for at least 31 weeks after the last dose.
Use in Lactation: Limited data from published literature report presence of cisplatin in human milk. Advise pregnant women not to breastfeed during treatment with cisplatin.