Vinorelbine Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, embryofetal toxicity was observed with administration at doses approximately 0.18 times the human therapeutic dose.
Comments:
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-This drug may damage spermatozoa. Males with female sexual partners of reproductive potential should use highly effective contraception during and for 3 months after therapy.
-Based on animal findings, this drug may cause decreased fertility in males.
Animal studies have revealed evidence of embryotoxicity (e.g., reduced fetal weight, delayed ossification) at doses less than the equivalent therapeutic dose in humans. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Vinorelbine Breastfeeding Warnings
Use is contraindicated.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It is probably impractical to resume breastfeeding after therapy with this drug because of the its long half-life.
See references
