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.

See references

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 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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