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
Contraindicated (0)
Serious - Use Alternative (4)
- adenovirus types 4 and 7 live, oral
dactinomycin decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- influenza virus vaccine quadrivalent, adjuvanted
dactinomycin decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
dactinomycin decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- palifermin
palifermin increases toxicity of dactinomycin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
Monitor Closely (18)
- acalabrutinib
acalabrutinib, dactinomycin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and dactinomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
dactinomycin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
dactinomycin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
dactinomycin, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- erythromycin base
erythromycin base will increase the level or effect of dactinomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of dactinomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of dactinomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- erythromycin stearate
erythromycin stearate will increase the level or effect of dactinomycin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- fingolimod
dactinomycin increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
dactinomycin, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- meningococcal group B vaccine
dactinomycin decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, dactinomycin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
dactinomycin and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- siponimod
siponimod and dactinomycin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
dactinomycin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, dactinomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, dactinomycin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
Minor (2)
- doxorubicin
doxorubicin, dactinomycin. unspecified interaction mechanism. Minor/Significance Unknown. Pediatric patients receiving concomitant doxorubicin and dactinomycin have manifested acute "recall" pneumonitis at variable times after local radiation therapy.
- doxorubicin liposomal
doxorubicin liposomal, dactinomycin. unspecified interaction mechanism. Minor/Significance Unknown. Pediatric patients receiving concomitant doxorubicin and dactinomycin have manifested acute "recall" pneumonitis at variable times after local radiation therapy.
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| dactinomycin intravenous - | 0.5 mg vial |  | |
| dactinomycin intravenous - | 0.5 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
dactinomycin intravenous
DACTINOMYCIN - INJECTION
(dack-tin-oh-MY-sin)
COMMON BRAND NAME(S): Cosmegen
USES: Dactinomycin is used to treat cancer. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: This medication is given by injection into a vein over 10 to 15 minutes by a health care professional as directed by your doctor, usually once daily for 1 to 5 days. If this medication accidentally leaks into surrounding tissue when being given, the skin and/or muscle may be severely damaged. Tell your doctor or nurse right away if you have pain, burning, redness, blistering, or irritation at the injection site.Dosage is based on your medical condition, weight, body size, and response to treatment. Your doctor will order lab tests to make sure you can receive your next dose. Keep all medical/lab appointments.Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the powder.
SIDE EFFECTS: See also How to Use section.Nausea, vomiting, or diarrhea may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.Temporary hair loss is another common side effect. Normal hair growth should return after treatment has ended.Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests. Serious side effects may not happen until days to weeks after your treatment.Pain/sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods. Tell your doctor right away if these effects persist/worsen or if you have trouble swallowing.Tell your doctor right away if you have any serious side effects, including: unusual weight gain, signs of liver problems (nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine, painful/difficult urination, red/pinkish urine).This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.Dactinomycin may increase the risk of other cancers (such as leukemia). Consult your doctor for more details.When dactinomycin is given after radiation treatment, it can sometimes cause a serious skin reaction that looks likes a severe sunburn (radiation recall). The reaction usually develops within days to months after treatment on the skin area previously treated with radiation. Throat problems can also be part of radiation recall with dactinomycin. Tell your doctor right away if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using dactinomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection (such as herpes, chickenpox), liver problems, kidney problems, blood disorders (such as anemia, clotting problems), previous chemotherapy/radiation treatment.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (such as flu, chickenpox).To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dactinomycin. Dactinomycin may harm an unborn baby. Females using this medication should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Males using this medication should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 14 days after stopping treatment. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain lab tests (such as antibiotic drug levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2020. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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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.
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