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Plerixafor Pregnancy and Breastfeeding Warnings

Plerixafor is also known as: Mozobil

Plerixafor Pregnancy Warnings

Use is not recommended unless clearly needed and the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Advise women of reproductive potential of the possible hazard to the fetus and to use effective contraception to avoid becoming pregnant during treatment.

Animal studies have revealed embryofetal toxicities including fetal death, increased resorptions, post-implantation loss, decreased fetal weights, anophthalmia, shortened digits, cardiac interventricular septal defect, ringed aorta, globular heart, hydrocephaly, dilatation of olfactory ventricles, and retarded skeletal development. These toxicities occurred mainly at a dose approximately 10 times the recommended human dose when compared on a mg/m2 basis. Based on its mechanism of action, this drug is suggested to cause congenital malformations. The effect on human fertility is unknown. There are no controlled data in human pregnancy. 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

Plerixafor Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Mozobil (plerixafor)." Genzyme Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Mozobil (plerixafor)." Genzyme Corporation, Cambridge, MA.

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