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DBL Vinblastine

DBL Vinblastine Use In Pregnancy & Lactation

vinblastine

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
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 vinblastine 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 6 months following last dose of vinblastine 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 3 months following the last dose of vinblastine sulfate.
Pregnancy: Although information on the use of vinblastine during pregnancy is limited, the drug may cause foetal toxicity when administered to pregnant women. The drug causes resorption of foetuses in animals and produces gross foetal abnormalities in surviving offspring. There are no adequate and controlled studies to date using vinblastine in pregnant women, and the drug should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective.
If vinblastine is administered during pregnancy or the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the foetus.
Fertility: The effect of vinblastine on fertility in humans is not fully known.
Based on clinical reports, male and female fertility may be compromised. Aspermia has been reported in men. Sperm abnormalities have been noticed in mice.
Additional studies in mice demonstrated no reduction in fertility in males. It is recommended to discuss fertility preservation with men and women prior to treatment.
Breast-feeding: It is not known whether vinblastine is excreted in human milk. Because of the potential for serious adverse reactions due to vinblastine in nursing infants, the mother should be advised not to breast-feed during the entire vinblastine sulfate therapy and for 1 week following last dose of treatment. Alternatively, a decision should be made whether to discontinue treatment with vinblastine sulfate, taking into account the importance of the drug to the mother.
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