CCoPE
Date: 2008-12-11

Question:
Hello- I am wondering if there are any registries or other data sources regarding perinatal outcomes of fetuses exposed to Temazolamide? (Case = 25 weeks GA with nonoperable recurrence of gliobastoma). Thank-you

Answer:

If you are a patient, consult your physician. The following information should not replace the assessment and advice you have been receiving from your physician (cancer specialist, obstetrician, or any other healthcare provider). It is offered for your information only.

Temozolomide (Temodol) is an antineoplastic agent used for the treatment of adults diagnosed with glioblastoma in conjunction with radiotherapy. It has low plasma protein binding (much of it will remain free and available in the plasma) and a short elimination half-life. It is a pro-drug and gets metabolized to MTIC which exerts its cytotoxic effect on the tumor by alkylation of the DNA. Animal studies in rats and rabbits showed numerous malformations. Human data are scarce, and it is not known whether temozolomide crosses the placenta; however the low molecular size of the compound and its low binding to protein suggests that it is capable of crossing to the fetus and embryo.

The recommended treatment is 42 days of consecutive therapy with temozolomide followed by an increased dose for 6 cycles (five consecutive days in each 4 week cycle). Therefore exposure can occur throughout most of gestation. Women of childbearing age should prevent pregnancy; however if pregnancy does occur when receiving treatment, treatment should not be discontinued, but women should be advised of the unknown but potentially high risk to the embryo/fetus