Talquetamab Pregnancy and Breastfeeding Warnings

Brand names: Talvey

Medically reviewed by Drugs.com. Last updated on Mar 12, 2024.

Talquetamab Pregnancy Warnings

Use should be avoided; may cause fetal harm.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug may cause fetal harm when administered to a pregnant patient.

Comments:
-Verify pregnancy status of females of reproductive potential prior to treatment initiation, and advise use of effective contraception during therapy and for 3 months after last dose.
-There are no data available on use of this drug in pregnant women to inform a drug-associated risk.
-The immune activation caused by the mechanism of action of this drug may compromise pregnancy maintenance.
-This drug is a humanized IgG antibody; maternal IgG antibodies are known to cross the placenta.

Animal reproductive or developmental toxicity studies have not been conducted with this drug. 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

Talquetamab Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Advise women not to breastfeed during treatment and for 3 months after last dose of this drug.
-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 local effects of gastrointestinal exposure and limited systemic exposure in the breastfed child are unknown.
-This drug is a humanized IgG antibody; maternal IgG antibodies are known to be present in human milk.

See references

Further information

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