Marqibo Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: D
Comments:
-Based on its mechanism of action and findings from animal studies, this drug can cause fetal harm when administered to pregnant women.
-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.
Animal studies have revealed evidence of embryofetal toxicity (skeletal and visceral fetal malformations), decreases in fetal weights, increased numbers of early resorptions and post-implantation losses, and decreased maternal body weights. Studies indicate that this drug can impair male fertility and can cause testicular degeneration and atrophy and epididymal aspermia. There are no controlled data in human pregnancy.
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
Marqibo Breastfeeding Warnings
Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. It is probably impractical to resume breastfeeding after treatment with this drug because of the its long half-life.
A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-The effects in the nursing infant are unknown.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
See references