Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 500mcg/vial
Wilms Tumor
Indicated for Wilms tumor as part of a multiphase, combination chemotherapy regimen
45 mcg/kg IV every 3-6 weeks for up to 26 weeks
Rhabdomyosarcoma
Indicated for rhabdomyosarcoma as part of a multiphase, combination chemotherapy regimen
15 mg/kg IV on Days 1-5 every 3-9 weeks for up to 112 weeks
Ewing Sarcoma
Indicated for Ewing sarcoma as part of a multiphase, combination chemotherapy regimen
1250 mcg/m² IV q3Week for 51 weeks
Gestational Trophoblastic Neoplasms
Indicated for postmenarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen
Nonmetastatic and low-risk metastatic disease: 12 mcg/kg IV qDay for 5 days as a single agent
High-risk metastatic disease: 500 mcg IV on Days 1 and 2 q2Weeks for up to 8 weeks
Testicular Cancer
Indicated for metastatic, nonseminomatous testicular cancer, as part of a multiphase, combination chemotherapy regimen
1000 mcg/m² IV once q3Weeks for 12 weeks as part of a cisplatin-based, multi-agent combination regimen
Locoregional Solid Malignancies
Indicated for locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion
Calculate dose for obese or edematous patients based on ideal body weight
Pelvis/lower extremity: 50 mcg/kg IV once in combination with melphalan
Upper extremity: 35 mcg/kg IV once in combination with melphalan
Malignant Germ Cell Tumors of the Ovary (Off-label)
Palliative therapy only
300 mcg/m²/day IV for 5 days q4Weeks (in combination with vincristine and cyclophosphamide) (Slayton 1985)
Dosage Modifications
Reduce dose by 50% during concomitant radiation; use caution when administering within 2 months of radiation
Dosing Considerations
Verify the pregnancy status of females of reproductive potential prior to initiating (see Pregnancy)
Dosage Forms & Strengths
injection, powder for reconstitution
- 500mcg/vial
Wilms Tumor
Indicated for Wilms tumor as part of a multiphase, combination chemotherapy regimen
45 mcg/kg IV every 3-6 weeks for up to 26 weeks
Rhabdomyosarcoma
Indicated for rhabdomyosarcoma as part of a multiphase, combination chemotherapy regimen
15 mg/kg IV on Days 1-5 every 3-9 weeks for up to 112 weeks
Ewing Sarcoma
Indicated for Ewing sarcoma as part of a multiphase, combination chemotherapy regimen
1250 mcg/m² IV q3Week for 51 weeks
Gestational Trophoblastic Neoplasms
Indicated for postmenarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen
Nonmetastatic and low-risk metastatic disease: 12 mcg/kg IV qDay for 5 days as a single agent
High-risk metastatic disease: 500 mcg IV on Days 1 and 2 q2Weeks for up to 8 weeks
Testicular Cancer
Indicated for metastatic, nonseminomatous testicular cancer, as part of a multiphase, combination chemotherapy regimen
1000 mcg/m² IV once q3Weeks for 12 weeks as part of a cisplatin-based, multi-agent combination regimen
Malignant Germ Cell Tumors (Off Label)
Palliative therapy only
≥14 years: 300 mcg/m²/day IV for 5 days q4Weeks (in combination with vincristine and cyclophosphamide) (Slayton 1985)
Dosage Modifications
Reduce dose by 50% during concomitant radiation; use caution when administering within 2 months of radiation
Dosing Considerations
Verify the pregnancy status of females of reproductive potential prior to initiating (see Pregnancy)
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
Frequency Not Defined
Also see Cautions
Common adverse effects include infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity
Secondary malignancy and leukemia
Veno-occlusive disease
Extravasation
Myelosuppression
Severe mucocutaneous reactions
Renal toxicity
Hepatotoxicity
Potentiation of radiation toxicity and radiation recall
Postmarketing Reports
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
Warnings
Contraindications
None
Cautions
Increased risk of secondary malignancy or leukemia following treatment
Severe and fatal veno-occlusive disease reported; risk increased with young age (ie, <4 yr) or concomitant radiotherapy; monitor for increased AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites; consider delaying next dose; resume, reduce dose, or permanently discontinue based on severity of reaction and disease being treated
If extravasation occurs, immediately interrupt the injection or infusion and apply ice (see Administration)
Severe and fatal myelosuppression reported; monitor blood cell counts before each cycle; delay next dose if severe myelosuppression has not improved; consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated
Severe mucocutaneous reactions (eg, Steven-Johnson syndrome, toxic epidermal necrolysis) can occur; permanently discontinue
Renal toxicity reported; monitor creatinine and electrolytes frequently
Hepatotoxicity reported; monitor transaminases, alkaline phosphatase and bilirubin before and during treatment
Reduce dose by 50% during concomitant radiation; use caution when administering within 2 months of radiation
Can cause fetal harm; inform patients of potential risk to a fetus and to use effective contraception (see Pregnancy)
Drug interaction overview
- Vaccination with live viral vaccines is not recommended before or during treatment; not studied
- Published in vitro studies report that dactinomycin may be a P-glycoprotein and OATP1B3 substrate
Pregnancy & Lactation
Pregnancy
Based on findings from animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women
In animal reproduction studies, administration to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose
Verify the pregnancy status of females of reproductive potential prior to initiating
Contraception
- Females of reproductive: Use effective contraception during treatment and for at least 6 months after the final dose
- Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after the final dose
Lactation
There are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Actinomycin antibiotic; intercalates into DNA base pairs preventing RNA, DNA, and protein synthesis
Distribution
Protein bound: Low
Concentrates in nucleated cells and does not penetrate the blood-brain barrier
Metabolism
Minimally metabolized
Elimination
Excretion: 30% in urine and feces over 1 week
Administration
IV Incompatibilities
Y-site: diazepam, filgrastim, pantoprazole, phenytoin
IV Compatibilities
Solution: D5W, NS
Y-site: acyclovir, alfentanil, allopurinol, amifostine, amikacin, aminophylline, amphotericin B, ampicillin, aztreonam, bleomycin, buprenorphine, calcium chloride, calcium gluconate, cefepime, cimetidine, cyclophosphamide, dacarbazine, daptomycin, daunorubicin, dexamethasone sodium phosphate, ephedrine, etoposide PO4, fludarabine, furosemide, ganciclovir, gemcitabine, granisetron, ifosfamide, magnesium sulfate, melphalan, mesna, midazolam, ondansetron, sargramostim, teniposide, thiotepa, topotecan, vancomycin, vinblastine, vincristine, vinorelbine, voriconazole
IV Preparation
Follow cytotoxic handling and disposal guidelines
Reconstitute with 1.1 mL of preservative-free sterile water for injection to yield a final concentration of 500 mcg/mL
Resulting solution should appear clear, gold-colored
Further dilute reconstituted product with D5W or 0.9% NaCl to yield concentration >10 mcg/mL
Contains no preservative, discard any unused portions
IV Administration
Vesicant
Administer diluted reconstituted product IV over 10-15 minutes
Do not use in-line cellulose ester membrane filter
Do not give IM or SC
Extravasation Management
Discontinue for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation
Confirmed or suspected extravasation
- Terminate injection or infusion immediately and restart in another vein
- Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days
- Observe closely and consult plastic surgery if necessary based on severity of reaction
Storage
Unopened vials
- Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)
- Protect from light and humidity
Reconstituted vials
- Store at 20-25°C (68-77°F); for no more than 4 hr from reconstitution to completion of administration
- Cytotoxic drug; follow applicable special handling and disposal procedures
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Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.