Fitusiran Pregnancy and Breastfeeding Warnings
Brand names: Qfitlia
Medically reviewed by Drugs.com. Last updated on May 5, 2025.
Fitusiran Pregnancy Warnings
Benefit should outweigh risk.
US FDA pregnancy category: Not assigned
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-The effects on the fetus or on reproductive capacity are unknown.
-Concomitant use of hormonal contraceptives may increase the risk of thrombotic events; advise patients to use alternative, non-hormonal contraception prior to starting therapy and during treatment
---Estrogen-based contraceptives are a risk factor for women with inherited antithrombin deficiency.
-This drug has not been studied in female patients.
Animal reproduction 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.
Fitusiran Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects on milk production and in the nursing infant are unknown.
-Consider the developmental and health benefits of breastfeeding along with the mother's need for this drug against any potential adverse effects on the breastfed child from this drug or the underlying maternal condition.
See also
References for pregnancy information
- (2025) "Product Information. Qfitlia (fitusiran)." Genzyme Corporation
References for breastfeeding information
- (2025) "Product Information. Qfitlia (fitusiran)." Genzyme Corporation
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.