Matulane Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy.
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 contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Brief statement (only if US FDA pregnancy category: Not assigned.)
Comments:
-This drug can harm a developing fetus.
-There have been reports of malformations in the offspring of women who were exposed to this drug in combination with other antineoplastic agents during pregnancy.
-Adequate methods of contraception should be encouraged.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-This drug inhibits DNA, RNA, and protein synthesis which can impair fertility in both males and females.
See references
