Temozolomide (monograph) Pregnancy Warnings
Animal studies have shown teratogenicity at doses higher than the maximum dose used clinically. Fetal malformations of the external organs, soft tissues, and skeleton occurred. Embryolethality occurred in animal studies as indicated by increased resorptions. There are no controlled data in human pregnancy.
Male patients should be advised to seek advice regarding cryopreservation of sperm prior to treatment due to the possibility of irreversible infertility.
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
AU: Use is contraindicated in women who are pregnant or contemplating pregnancy.
US and UK: Use is not recommended in women who are pregnant or contemplating pregnancy.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments: Encourage use of adequate methods of contraception in male and female patients during treatment and for at least 6 months following the last dose.
See references
