Marstacimab Pregnancy and Breastfeeding Warnings

Brand names: Hympavzi

Medically reviewed by Drugs.com. Last updated on Feb 4, 2025.

Marstacimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-This drug can harm a developing fetus.
-Monoclonal antibodies can be actively transported across the placenta.
-Females of childbearing potential should use effective contraception during treatment with this drug and for 2 months after the last dose.

Animal studies have not been reported. 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

Marstacimab Breastfeeding Warnings

Use with caution.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-Maternal immunoglobulin G and monoclonal antibodies are present in human milk.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-According to some authorities: Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

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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