Tofersen Pregnancy and Breastfeeding Warnings

Brand names: Qalsody

Medically reviewed by Drugs.com. Last updated on Oct 31, 2023.

Tofersen Pregnancy Warnings

The manufacturer makes no recommendation regarding the use of this drug or its safety during pregnancy.

Risk summary: There are no data available on use of this drug in pregnant patients to inform a drug-associated risk of major birth defects, miscarriage, or other adverse outcomes.

Animal studies in which this drug was administered subcutaneously during the period of organogenesis resulted in no adverse side effects on embryofetal development, including at doses up to approximately 20 times the recommended human dose. 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

Tofersen Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-This drug was detected in the milk of lactating mice following subcutaneous administration.

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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