Concizumab Pregnancy and Breastfeeding Warnings

Brand names: Alhemo

Medically reviewed by Drugs.com. Last updated on Apr 1, 2025.

Concizumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action, this drug can 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:
-Verify the pregnancy status of females of reproductive potential before starting therapy.
-Women of childbearing potential should use highly effective contraception during treatment and for 7 weeks after the last dose.
-The benefits and thromboembolic risks of contraceptive(s) used should be assessed by the prescriber.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have not been reported. This drug targets tissue factor pathway inhibitor, which is critical for embryofetal development, and its knockout in mice is associated with embryofetal lethality. Monoclonal antibodies can be actively transported across the placenta and may cause fetal harm. There are no controlled data in human pregnancy.

It is unknown whether this drug can affect fertility. Animal studies in primates did not indicate direct or indirect harmful effects with respect to fertility. No data are available in humans.

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

Concizumab Breastfeeding Warnings

Until more data are available, this drug should be used with caution, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug and for 7 weeks after the last dose.

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

Comments:
-This drug is a humanized immunoglobulin G (IgG) antibody, and human IgG antibodies are known to be present in maternal milk.
-As this drug may be excreted in breast milk, particularly in the first few days after birth, a risk to the breastfed infant cannot be excluded during this short period. Afterwards, use could be considered if clinically needed.
-Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.

This drug is a large protein molecule; therefore, the amount in milk is likely to be very low and absorption is expected to be minimal because it is probably partially destroyed in the infant's gastrointestinal tract.

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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