Tarlatamab Pregnancy and Breastfeeding Warnings
Brand names: Imdelltra
Medically reviewed by Drugs.com. Last updated on Jul 12, 2024.
Tarlatamab Pregnancy Warnings
Safety has not been established during pregnancy.
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 woman.
Comments:
-There are no available data on the use of this drug in pregnant women to inform a drug-associated risk.
-Human immunoglobulin G (IgG) and related proteins are known to cross the placenta barrier; therefore, this drug has the potential to be transmitted from the mother to the developing fetus. Women should be advised of this risk.
-This drug causes immune activation that may compromise pregnancy maintenance.
An animal reproduction study showed that a murine surrogate molecule administered IV to pregnant mice crossed the placenta barrier and did not cause maternal or embryofetal toxicity. No additional animal studies have 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.
Tarlatamab Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Maternal IgG is known to be present in human milk. The effects of local gastrointestinal and limited systemic exposure in the breastfed child are unknown.
-Advise patients not to breastfeed during treatment and for 2 months after the last dose due to the potential risk for serious adverse reactions in the breastfed child.
References for pregnancy information
- (2024) "Product Information. Imdelltra (tarlatamab)." Amgen USA
References for breastfeeding information
- (2024) "Product Information. Imdelltra (tarlatamab)." Amgen USA
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
