Motixafortide Pregnancy and Breastfeeding Warnings

Brand names: Aphexda

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Motixafortide Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Based on its mechanism of action, this drug has the potential to harm a developing fetus if given to a pregnant woman.
-Inform pregnant women about the potential risk to a fetus.
-Before starting this treatment, verify the pregnancy status of female of reproductive potential.
-Women of reproductive potential should use effective contraception while undergoing this treatment and for a period of 8 days following their last dose.

Animal models have shown a link between C-X-C Motif Chemokine Receptor 4 (CXCR4)/ stromal-derived factor-1 (SDF-1) signaling pathway and adverse outcomes in the embryo-fetal development and suggest potential risks to the normal placental development. There haven't been any animal studies conducted to specifically assess the impact of this drug on reproduction and fetal development. There are no controlled data in human pregnancy.

Disrupting the CXCR4/SDF-1 signaling pathway in mice and other experimental models has been associated increased embryo-fetal lethality, and impairment of vascularization, cardiac anomalies, reduced hematopoiesis, impaired bone marrow myelopoiesis, disorganized neural layers in cerebellum, and reduced neural innervation of limbs.

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

Motixafortide Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 8 days after the last dose.

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

Comments:
-The effects in the nursing infant are unknown.

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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