Idamycin pfs Pregnancy Warnings
AU: Contraindicated
UK, US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments:
-This drug can harm a developing fetus.
-Women of childbearing potential should be advised not to become pregnant during treatment and to use adequate contraception during therapy.
-This drug can induce chromosomal damage in human spermatozoa; therefore, males undergoing therapy should use effective contraceptive methods for up to 3 months after completing treatment.
-Women of childbearing potential should be informed of the potential hazard to the fetus.
-Women attempting to have children after completion of therapy should be advised to obtain genetic counseling first, if appropriate.
A single case in which idarubicin was given during pregnancy has been reported. Data are available for other anthracyclines.
A 26-year-old woman presented at 20 weeks' gestation with acute myelogenous leukaemia (AML) received daunorubicin and cytarabine as induction therapy, but required retreatment after 3 weeks due to unequivocal evidence of persistence of acute leukaemia. She received mitoxantrone (mitozantrone) and cytarabine as her second course of chemotherapy. Complete remission and a normal foetal growth rate were documented after a total of 60 days from the start of therapy. Due to the long period of time required to obtain remission, it was decided to consolidate therapy with idarubicin 10 mg/m2 (with cytarabine) at approximately 32 weeks' gestation. She tolerated the treatment well and was discharged only to return two days later complaining of abdominal pain and lack of foetal activity for six to eight hours. After ultrasonographic evidence of foetal death, labour was induced, and the patient delivered a stillborn foetus with no obvious congenital malformations weighing 2,200 grams. Autopsy permission was denied.
Limited data have shown that it is possible to give a single very high dose cycle of chemotherapy for AML in younger women without compromising fertility.
See references
