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.
Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms
Tired of the same old research?
Check Latest Advances

Related Clinical Trials

Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes

Summary: This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to...

Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma

Summary: This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

Summary: This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB. Historically, most children with type I PPB had su...

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: