Brand Name

Dactinomycin

View Brand Information
FDA approval date: July 31, 2019
Classification: Actinomycin
Form: Injection

What is Dactinomycin?

Dactinomycin for injection is an actinomycin indicated for the treatment of: adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.

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Brand Information

Dactinomycin (Dactinomycin)
1DOSAGE FORMS AND STRENGTHS
For injection: 500 mcg as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
  • Secondary Malignancy and Leukemia
  • Veno-occlusive Disease
  • Extravasation
  • Myelosuppression
  • Immunizations
  • Severe Mucocutaneous Reactions
  • Renal Toxicity
  • Hepatotoxicity
  • Potentiation of Radiation Toxicity and Radiation Recall
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, acne, erythema multiforme, Stevens Johnson Syndrome, radiation recall, toxic epidermal necrolysis
Musculoskeletal and connective tissue: myalgia, growth retardation
Renal and urinary: renal impairment, renal failure
General: fatigue, fever, malaise
4DESCRIPTION
Dactinomycin is an actinomycin. Dactinomycin is produced by
Structural Formula of Dactinomycin
Dactinomycin for Injection, USP for intravenous use is a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. Each vial contains 500 mcg of dactinomycin and 20 mg of mannitol.
5REFERENCES
1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
6HOW SUPPLIED/STORAGE AND HANDLING
Dactinomycin for Injection, USP for intravenous use is an amorphous yellow to orange powder. Each vial contains 500 mcg (0.5 mg) of dactinomycin and 20 mg of mannitol. It is supplied as follows:
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