Dactinomycin (2 brand names, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- COSMEGEN
- DACTINOMYCIN
Contraindications
None.
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: • Secondary Malignancy and Leukemia [see Warnings and Precautions (5.1)] • Veno-occlusive Disease [see Warnings and Precautions (5.2)] • Extravasation [see Warnings and Precautions (5.3)] • Myelosuppression [see Warnings and Precautions (5.4)] • Immunizations [see Warning and Precautions (5.5)] • Severe Mucocutaneous Reactions [see Warnings and Precautions (5.6)] • Renal Toxicity [see Warnings and Precautions (5.7)] • Hepatotoxicity [see Warnings and Precautions (5.8)] • Potentiation of Radiation Toxicity and Radiation Recall [see Warnings and Precautions (5.9)] Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity. The following adverse reactions have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections: infections including sepsis with fatal outcome Hematologic: anemia, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia, disseminated intravascular coagulation Immune system: hypersensitivity Metabolism and nutrition: anorexia, hypocalcemia, tumor lysis syndrome Nervous system: peripheral neuropathy Ocular: optic neuropathy Vascular: thrombophlebitis, hemorrhage Respiratory, thoracic and mediastinal: pneumonitis, pneumothorax Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal ulceration, cheilitis, dysphagia, esophagitis, ulcerative stomatitis, ascites, proctitis, mucositis Hepatobiliary: liver function test abnormalities, hepatomegaly, hepatitis, hepatic failure with reports of death, hepatic veno-occlusive disease Dermatologic: alopecia, rash, dermatitis, ac
Mechanism of Action
Dactinomycin is a cytotoxic actinomycin that binds DNA and inhibits RNA synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.