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Procarbazine Pregnancy and Breastfeeding Warnings

Procarbazine is also known as: Matulane

Procarbazine Pregnancy Warnings

There are case reports of malformations in the offspring of women who were exposed to procarbazine in combination with other neoplastic agents during pregnancy. There are 5 known cases in which procarbazine was administered (in combination with other antineoplastic agents) during the first trimester. One fetus was electively terminated, the other 4 suffered congenital malformations. There is one known case of a woman in her 12th week receiving 50 mg daily for 30 days. She gave birth at term to a normal infant. Procarbazine is teratogenic in the rat when given at doses approximately 4 to 13 times the maximum recommended human therapeutic dose. Neurogenic tumors were noted in the offspring of rats given intravenous injections of 125 mg/kg of procarbazine on day 22 of gestation. Unscheduled DNA synthesis in the testis of rabbits and decreased fertility in male mice treated with procarbazine have been reported. This drug, which inhibits DNA, RNA, and protein synthesis, might be expected to have adverse effects on peri- and postnatal development and on gametogenesis.

Procarbazine has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of teratogenicity. Azoospermia and antifertility effects have been reported in patients receiving procarbazine as part of a combination chemotherapy. There are no controlled data in human pregnancy. Procarbazine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

Procarbazine Breastfeeding Warnings

There are no data on the excretion of procarbazine into human milk. Because of the potential for tumorigenicity shown in animal studies, mothers should not nurse while receiving this medication.

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