Temodal Use In Pregnancy & Lactation

Effects on fertility: TEMODAL is contraindicated in women who intend to become pregnant, and effective contraception should be used by female patients during and for at least 6 months after treatment with temozolomide (see Contraindications).
Use in men: Effective contraception should be used by male patients treated with TEMODAL. Temozolomide can have genotoxic effects. Therefore, men being treated with temozolomide are advised not to father a child for at least 3 months after receiving the final dose and to seek advice on cryoconservation of spermatozoa prior to treatment because of the possibility of irreversible impairment in fertility due to therapy with temozolomide. Semen donation is also not advised during treatment and for at least 3 months after the final dose.
Use in pregnancy: Cytotoxic agents can produce spontaneous abortion, foetal loss and birth defects. There are no studies in pregnant women. In preclinical studies in rats and rabbits administered 150 mg/m², (associated with systemic exposure below that anticipated in humans) teratogenicity and/or foetal toxicity were demonstrated. TEMODAL, therefore, should not be administered to pregnant women. If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus. Women of childbearing potential should be advised to avoid pregnancy if they are going to receive TEMODAL treatment and for 6 months after discontinuation of TEMODAL therapy.
Use in lactation: It is not known whether TEMODAL is excreted in human milk. A peri/postnatal study in rats found that treatment with temozolomide at doses of greater than 25 mg/m²/day decreased pup growth and retarded development. Given its potential adverse effects in the newborn, TEMODAL must not be used by breastfeeding women.