Gleevec Pregnancy Warnings
Animal reproductive studies have shown teratogenicity and increased incidence of congenital abnormalities following prenatal exposure to this drug. There have been reports of spontaneous abortions and infant congenital anomalies from women who have taken this drug.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.
Use is not recommended.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on human and animal data, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-This drug can harm a developing fetus.
-Advise female patients of reproductive potential to use adequate contraception during therapy and for 14 days after.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
See references
Gleevec Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Yes
Comments:
-A breastfed infant could receive up to 10% of the maternal therapeutic dose based on body weight.
-Women should not breastfeed during treatment and for 1 month after the last dose.
Although a few breastfed infants experienced no adverse effects during maternal use of this drug, no long-term data are available. Avoiding nursing for 8 to 9 hours after a dose would probably reduce the dosage that the infant receives. Most experts recommend that breastfeeding be discontinued during therapy and for 1 month after.
See references
