Crovalimab Pregnancy and Breastfeeding Warnings

Brand names: PiaSky

Medically reviewed by Drugs.com. Last updated on Aug 19, 2024.

Crovalimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are insufficient data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Human immunoglobulin G (IgG) antibody is known to cross the placenta, with transmission peaking during the third trimester; therefore, this drug may be transmitted from the mother to the developing fetus.
-There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) in pregnancy.

Animal studies have failed to reveal evidence of adverse developmental effects. Administration of this drug to pregnant monkeys during the period of organogenesis through parturition at doses resulting in maternal exposure 14 times the exposure at the maximum recommended human dose did not demonstrate adverse effects on pregnancy, or on infant viability, growth, and development. There are no controlled data in human pregnancy.

PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery.

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

Crovalimab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 9 months after the last dose.

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.
-The effects of local gastrointestinal exposure and limited systemic exposure in the nursing infant are unknown; there is a potential for serious adverse reactions.
-This drug is a monoclonal antibody; endogenous human immunoglobulin G (IgG) and monoclonal antibodies are transferred in human milk.

See references

Further information

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