Hemopoietic depression is the most common toxicity with DTIC-Dome and involves primarily the leukocytes and platelets, although, anemia may sometimes occur. Leukopenia and thrombocytopenia may be severe enough to cause death. The possible bone marrow depression requires careful monitoring of white blood cells, red blood cells, and platelet levels. Hemopioetic toxicity may warrant temporary suspension or cessation of therapy with DTIC-Dome.

Hepatic toxicity accompanied by hepatic vein thrombosis and hepatocellular necrosis resulting in death, has been reported. The incidence of such reactions has been low; approximately 0.01% of patients treated. This toxicity has been observed mostly when DTIC-Dome has been administered concomitantly with other anti-neoplastic drugs; however, it has also been reported in some patients treated with DTIC-Dome alone.

Anaphylaxis can occur following the administration of DTIC-Dome.

Hospitalization is not always necessary but adequate laboratory study capability must be available. Extravasation of the drug subcutaneously during intravenous administration may result in tissue damage and severe pain. Local pain, burning sensation, and irritation at the site of injection may be relieved by locally applied hot packs.

Carcinogenicity of DTIC was studied in rats and mice. Proliferative endocardial lesions, including fibrosarcomas and sarcomas were induced by DTIC in rats. In mice, administration of DTIC resulted in the induction of angiosarcomas of the spleen.

Pregnancy Category C. DTIC-Dome has been shown to be teratogenic in rats when given in doses 20 times the human daily dose on day 12 of gestation. DTIC when administered in 10 times the human daily dose to male rats (twice weekly for 9 weeks) did not affect the male libido, although female rats mated to male rats had higher incidence of resorptions than controls. In rabbits, DTIC daily dose 7 times the human daily dose given on Days 6-15 of gestation resulted in fetal skeletal anomalies. There are no adequate and well controlled studies in pregnant women. DTIC-Dome should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for DTIC-Dome in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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