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Brand Name

Dactinomycin

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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.

Approved To Treat

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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

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: