DBL Vincristine Sulfate Use In Pregnancy & Lactation

Women of childbearing potential/contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving vincristine sulfate. Due to the potential for genotoxicity, teratogenicity, and embryo toxicity, female patients of reproductive potential are advised to use highly effective contraception during treatment and for at least 7 months following last dose of vincristine sulfate.
Due to the potential for genotoxicity, male patients with female partners of reproductive potential are advised to use highly effective contraception during treatment and for at least 4 months following the last dose of vincristine sulfate.
Effects on fertility: Fertility following the treatment with vincristine sulfate for malignant disease has not been studied in humans. Clinical reports of both male and female patients who have received multiple-agent chemotherapy that included vincristine indicate that azoospermia and amenorrhoea can occur in post pubertal patients. Recovery occurred many months after completion of chemotherapy in some, but not all, patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhoea are much less likely.
Based on these clinical reports, male and female fertility may be compromised. It is recommended to discuss fertility preservation with men and women prior to treatment.
Use in pregnancy - Category D: Vincristine can cause fetal harm when administered to a pregnant woman. Vincristine sulfate can induce teratogenesis as well as embryo death with doses that are non-toxic to the pregnant animal. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus.
Use in lactation: It is not known whether vincristine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to vincristine in breast-fed infants, the mother should be advised not to breast-feed while on vincristine sulfate therapy and for 1 month following last dose of treatment. Alternatively, discontinue treatment taking into account the importance of the drug to the mother.