Plerixafor Pregnancy and Breastfeeding Warnings

Brand names: Mozobil

Medically reviewed by Drugs.com. Last updated on Oct 27, 2023.

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: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Based on animal studies this drug can cause fetal harm; administration to pregnant animals during organogenesis caused embryofetal mortality, structural abnormalities, and growth alterations at approximately 10 times the recommended human dose.
-Advise women of reproductive potential of the possible hazard to the fetus.
-Effective contraception should be used during treatment and for one week after the final dose.
-Verify pregnancy status of females of childbearing potential prior to therapy initiation.

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. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Plerixafor Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
--Because of the risk of serious adverse reactions, nursing is not recommended during treatment and for 1 week after drug discontinuation.

See references

Further information

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