DACTINOMYCIN

Other

Brand names: Dactinomycin

Intravenous

Mechanism of Action

12.1 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.

Indications

1 INDICATIONS AND USAGE 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. ( 1.1 ) adult and pediatric patients with rhabdomyosarcoma

as part of a multi-phase

combination chemotherapy regimen. ( 1.2 ) adult and pediatric patients with Ewing sarcoma

as part of a multi-phase

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Secondary Malignancy or Leukemia: Increased risk of secondary malignancies following treatment
1 ) Veno-occlusive Disease: Can cause severe or fatal VOD
Advise patients of the potential risk to a fetus and to use effective contraception
1 Secondary Malignancy or Leukemia The risk of developing secondary malignancies, including leukemia, is increased following treatment with dactinomycin

Known Side Effects

4 documented side effects by frequency

Drug Not Working

1-10%

Vomiting

1-10%

Fever

1-10%

Nausea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous