Teclistamab Pregnancy and Breastfeeding Warnings

Brand names: Tecvayli

Medically reviewed by Drugs.com. Last updated on Mar 3, 2024.

Teclistamab Pregnancy Warnings

Safety has not been established. According to some authorities, the use of this drug is not recommended during pregnancy.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary:
-This drug has the potential to harm a developing fetus when administered to a pregnant woman.

Comments:
-Females of reproductive potential should be advised to use effective contraception during therapy and for 5 months after the last dose.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should be apprised of the potential of this drug to cause fetal harm if used during pregnancy.
-This drug causes T-cell activation and cytokine release, which may compromise pregnancy maintenance.
-This drug is a humanized immunoglobulin G4-proline, alanine, and alanine (IgG4-PAA) antibody. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.
-Assess immunoglobulin levels in newborns of mothers treated with this drug, as this drug is associated with hypogammaglobulinemia.

Animal studies have not been reported. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Teclistamab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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

Comments:
-A risk to the newborn/infant cannot be excluded.
-Maternal immunoglobulin is known to be secreted into human milk.
-The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child are unknown.
-Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with this drug and for 5 months after the last dose.

See references

Further information

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