Mavorixafor Pregnancy and Breastfeeding Warnings

Brand names: Xolremdi

Mavorixafor Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on its mechanism of action, this drug is expected to cause fetal harm.

Comments:
-There is no data on use in pregnant women to know the risks of embryofetal developmental toxicities.
-Advise pregnant women of the potential risk to the fetus and to use effective contraception during treatment and for 3 weeks after the final dose.

Animal studies assessing this drug's effect on reproduction and fetal development have not been conducted. However, CXCR4/SDF-1 signaling plays an important role in mammalian embryo-fetal and placental development. Animal models have linked its reduction to multiple embryo developmental toxicities, especially hematopoietic, cardiovascular, and nervous system. There are no controlled data in human pregnancy.

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

Mavorixafor Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Data not available
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.
-Due to the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 weeks after the final dose.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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