Dactinomycin
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From MedlinePlus, U.S. National Library of Medicine
Actinomycin
Dosing in kidney impairment
Extravasation: Immediately interrupt the injection or infusion and apply ice. ( 2.7 , 5.3 ) Myelosuppression: Monitor blood cell counts before each cycle. Delay next dose if severe myelosuppression has not improved. Immunizations: Vaccination with live viral vaccines is not recommended before or during treatment. Severe Mucocutaneous Reactions: Discontinue treatment Renal Toxicity: Monitor creatinine and electrolytes frequently.
Permanently discontinue dactinomycin for injection in patients who experience a severe mucocutaneous reaction. 5.7 Renal Toxicity Abnormalities of renal function can occur with dactinomycin for injection. Monitor creatinine and electrolytes frequently during dactinomycin for injection therapy. 5.8 Hepatotoxicity Hepatotoxicity can occur with dactinomycin for injection.
Preparation and administration
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Preparation and Administration o Dactinomycin for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 o Visually inspect the vials for particulate matter and discoloration, whenever solution and container permit. Preparation
Reconstitute each vial by adding 1.1 mL of Sterile Water for Injection without preservative using aseptic techniques.
The reconstituted product should be a clear, gold-colored solution at a concentration of 500 mcg/mL.
Further dilute the reconstituted product with 5% Dextrose Injection or 0.9% Sodium Chloride Injection to yield concentrations greater than 10 mcg/mL.
Store at room temperature for no more than 4 hours from reconstitution to completion of injection or infusion. Discard after 4 hours.
Dactinomycin for injection does not contain a preservative. Discard any unused portions. Administration
Administer the diluted reconstituted product intravenously over 10 to 15 minutes.
Do not use in-line filters with a cellulose ester membrane. Management of Extravasation
Discontinue dactinomycin for injection for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation.
Manage confirmed or suspected extravasation as follows: o Terminate the injection or infusion immediately and restart in another vein. o Intermittent application of ice to the site for 15 minutes 4 times daily for 3 days [see Warnings and Precautions ].
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action dactinomycin can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . In animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose (see Data) . Advise pregnant women of the potential risk to a fetus [see Use in Special Populations (8.3) ]. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Dactinomycin was teratogenic in animals. Administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1,250 mcg/m 2 .
Lactation
8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating dactinomycin [see Use in Specific Population (8.1) ]. Contraception Dactinomycin can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Females Advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for at least 6 months after the final dose.
Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after the final dose [see Nonclinical Toxicology (13.1) ].
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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