Anifrolumab Pregnancy and Breastfeeding Warnings

Brand names: Saphnelo

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

Anifrolumab Pregnancy Warnings

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

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary:
-Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.
-Monoclonal immunoglobulin G (IgG) antibodies are known to cross the placenta as pregnancy progresses; this may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block.
-Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction.
-Maternal lupus nephritis increases the risk of hypertension and preeclampsia or eclampsia.

Comments:
-Female patients should be advised to inform their healthcare provider if they intend to become pregnant during therapy, or suspect they are pregnant before taking this drug.
-A pregnancy exposure registry is available in the United States.

In animal studies, no evidence of embryotoxicity or fetal malformations were reported at doses 28 times the maximum recommended human dose (MRHD) on an Area Under Curve (AUC) basis. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established in the United States. For more information about the registry or to report a pregnancy while on this drug, contact AstraZeneca at 1 877 693 9268 in the US.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused, or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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

Anifrolumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant and on milk production are unknown.
-Maternal immunoglobulin (IgG) is known to be secreted into human milk.
-A risk to the newborn or infant cannot be excluded.

-In animal studies, this drug was detected in the milk of female cynomolgus monkeys.

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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