Skip to main content

Anifrolumab Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Sep 15, 2021.

Anifrolumab is also known as: Saphnelo

Anifrolumab Pregnancy Warnings

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

US FDA pregnancy category: Not assigned.

Risk Summary: Available data on the use of this drug in pregnant women are insufficient to determine whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Monoclonal antibodies, such as this drug, are actively transported across the placenta as pregnancy progresses; therefore, the exposure to the fetus may be greater during the third trimester of pregnancy.

-A pregnancy exposure registry is available.
-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.

Animal studies did not show evidence of maternal toxicity, embryo-fetal toxicity, or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose. In infants, the mean serum concentrations of this drug on Day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. The drug concentrations in the infant serum were up to approximately 22 times the concentrations in the maternal milk, suggesting that the drug had transferred via the placenta. 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. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-693-9268.
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, taking into account the developmental and health benefits of breastfeeding along with the mother's clinical need for treatment and any potential adverse effects on the breast-fed child or from the underlying maternal condition.

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

-The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Saphnelo (anifrolumab)." Astra-Zeneca Pharmaceuticals (2021):

References for breastfeeding information

  1. "Product Information. Saphnelo (anifrolumab)." Astra-Zeneca Pharmaceuticals (2021):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.