Dactinomycin .5 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Actinomycin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dactinomycin is used in combination with other medications, surgery, and/or radiation therapy to treat Wilms' tumor (a type of kidney cancer that occurs in children) and rhabdomyosarcoma (cancer that forms in muscles) in children. Dactinomycin is also used in combination with other medications to treat certain types of testicular cancer and Ewing's sarcoma (a type of cancer in bones or muscles). Dactinomycin is also used alone or in combination with other medications to treat gestational trophoblastic tumors (a type of tumor that forms inside a woman's uterus while she is pregnant). Dactinomyc...
Read the full MedlinePlus article ↗- Dactinomycin is used for several serious cancers, including Wilms tumor (a kidney cancer, most often in children), rhabdomyosarcoma, Ewing sarcoma, and metastatic testicular cancer...
- What cancers is dactinomycin used to treat?
- No, dactinomycin is not a pill. It's given as an IV infusion — directly into a vein — in a clinic or hospital. Each infusion takes about 10 to 15 minutes. How often you receive it...
- How will I receive dactinomycin — is it a pill?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $194.02 | $194.02 / 1 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9120 | $307.411 / J9120 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| dactinomycin .5 mg/mL 39822-2100-02 | XGen | 1 vial | — | AP | FDA listed | — |
| Dactinomycin .5 mg 42658-0008-01 | Hisun | 1 vial | — | AP | FDA listed | — |
| Dactinomycin .5 mg/mL 55150-0431-01 | Eugia | 1 vial | — | AP | FDA listed | — |
| Dactinomycin .5 mg/mL 55150-0928-02 | Eugia | 1 vial | — | AP | FDA listed | — |
| Dactinomycin .5 mg/mLthis 71288-0129-02 | Meitheal | 1 vial | — | AP | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71288-0129-02 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-11-13 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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, combination chemotherapy regimen.
( 1.3 ) adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. ( 1.4 ) post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. ( 1.5 ) adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.
( 1.6 )
1.1Wilms Tumor Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.
1.2Rhabdomyosarcoma Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen.
1.3Ewing Sarcoma Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen.
1.4Metastatic Nonseminomatous Testicular Cancer Dactinomycin for Injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen.
1.5Gestational Trophoblastic Neoplasia Dactinomycin for Injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen.
1.6Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies Dactinomycin for Injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Wilms Tumor: The recommended dose is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks, as part of a multi-agent combination chemotherapy regimen. ( 2.1 ) Rhabdomyosarcoma: The recommended dose is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to 112 weeks, as part of a multi-agent combination chemotherapy regimen. ( 2.2 ) Ewing Sarcoma: The recommended dose is 1,250 mcg/m 2 intravenously once every 3 weeks for 51 weeks, as part of a multi-agent combination chemotherapy regimen.
( 2.3 ) Metastatic Nonseminomatous Testicular Cancer: The recommended dose is 1,000 mcg/m 2 intravenously every 3 weeks, as part of cisplatin-based, multi-drug chemotherapy regimen. ( 2.4 ) Gestational Trophoblastic Neoplasia: Non-metastatic and Low-risk Metastatic Disease: The recommended dose is 12 mcg/kg intravenously daily for 5 days, as a single agent. ( 2.5 ) High-risk Metastatic Disease: The recommended dose is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks, as part of a multi-agent combination chemotherapy regimen.
( 2.5 ) Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies: Lower Extremity or Pelvis: The recommend dose is 50 mcg/kg once with melphalan. ( 2.6 ) Upper Extremity: The recommended dose is 35 mcg/kg once with melphalan. ( 2.6 )
2.1Recommended Dosage for Wilms Tumor The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks.
2.2Recommended Dosage for Rhabdomyosarcoma The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to 112 weeks.
2.3Recommended Dosage for Ewing Sarcoma The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, is 1,250 mcg/m 2 intravenously once every 3 weeks for 51 weeks.
2.4Recommended Dosage for Metastatic Nonseminomatous Testicular Cancer The recommended dose of dactinomycin for injection, as part of a cisplatin-based, multi-agent combination chemotherapy regimen, is 1,000 mcg/m 2 intravenously once every 3 weeks for 12 weeks.
2.5Recommended Dosage for Gestational Trophoblastic Neoplasia The recommended dose of dactinomycin for injection for nonmetastatic and low-risk metastatic disease is 12 mcg/kg intravenously daily for five days as a single agent. The recommended dose of dactinomycin for injection, as part of a multi-agent combination chemotherapy regimen, for high-risk metastatic disease is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks.
2.6Recommended Dosage for Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies The recommended dose of dactinomycin for injection, in combination with melphalan, is 50 mcg/kg once for lower extremity or pelvis. The recommended dose of dactinomycin for injection, in combination with melphalan, is 35 mcg/kg once for upper extremity. Calculate the dose for obese or edematous patients based on ideal body weight.
2.7Preparation and Administration Dactinomycin for injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 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 per 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 con…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 500 mcg as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial. For injection: 500 mcg as a lyophilized powder in a single-dose vial. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Secondary Malignancy or Leukemia: Increased risk of secondary malignancies following treatment. ( 5.1 ) Veno-occlusive Disease: Can cause severe or fatal VOD. Monitor for elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites.
Consider delaying next dose. ( 5.2 ) 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. ( 5.4 ) Immunizations: Vaccination with live viral vaccines is not recommended before or during treatment. ( 5.5 ) Severe Mucocutaneous Reactions: Discontinue treatment ( 5.6 ) Renal Toxicity: Monitor creatinine and electrolytes frequently.
( 5.7 ) Hepatotoxicity: Monitor transaminases, alkaline phosphatase and bilirubin prior to and during treatment. ( 5.8 ) Potentiation of Radiation Toxicity and Radiation Recall: Reduce dose by 50% during concomitant radiation. Use caution when administering within two months of radiation.
( 5.9 ) Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.10 , 8.1 , 8.3 )
5.1Secondary Malignancy or Leukemia The risk of developing secondary malignancies, including leukemia, is increased following treatment with dactinomycin.
5.2Veno-occlusive Disease Severe and fatal hepatic veno-occlusive disease (VOD) can occur with dactinomycin. Risk factors for the development of VOD include age younger than 4 years or concomitant radiotherapy. After treatment with dactinomycin, monitor frequently for signs and symptoms of VOD; these include elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites.
If patients develop VOD, considering delaying next dose of dactinomycin. Resume, reduce dose or permanently discontinue based on severity of reaction and disease being treated.
5.3Extravasation Extravasation of dactinomycin can result in severe local tissue injury manifesting as blistering, ulcerations and persistent pain requiring wide excision surgery followed by split-thickness skin grafting. If any signs or symptoms of extravasation occur, immediately interrupt the injection or infusion. Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days [see Dosage and Administration ( 2.7 )] .
Observe closely and consult plastic surgery if necessary based on severity of reaction.
5.4Myelosuppression Severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia and anemia, can occur with dactinomycin. The nadir in neutrophil counts generally occurs 14 to 21 days after administration. Obtain complete blood counts prior to each treatment cycle.
Delay next dose of dactinomycin if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated.
5.5Immunizations The safety with live viral vaccines following dactinomycin has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.
5.6Severe Mucocutaneous Reactions Severe mucocutaneous reactions, such as Steven-Johnson syndrome and Toxic Epidermal Necrolysis (TEN), can occur with dactinomycin. Permanently discontinue dactinomycin in patients who experience a severe mucocutaneous reaction.
5.7Renal Toxicity Abnormalities of renal function can occur with dactinomycin. Monitor creatinine and electrolytes frequently during dactinomycin therapy.
5.8Hepatotoxicity Hepatotoxicity can occur with dactinomycin. Monitor AST, ALT, alkaline phosphatase, and bilirubin prior to and during dactinomycin therapy.
5.9Potentiation of Radiation Toxicity and Radiation Recall Dactinomycin can increase radiation-induced gastrointestinal toxicity, myelosuppression, or erythema and vesiculation of the skin or buccal and pharyngeal mucosa. Reduce the dose of dactinomycin by 50% during c…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Secondary Malignancy and Leukemia [see Warnings and Precautions ( 5.1 )] Veno-occlusive Disease [see Warnings and Precautions ( 5.2 )] Extravasation [see Warnings and Precautions ( 5.3 )] Myelosuppression [see Warnings and Precautions ( 5.4 )] Immunizations [see Warning and Precautions ( 5.5 )] Severe Mucocutaneous Reactions [see Warnings and Precautions ( 5.6 )] Renal Toxicity [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Potentiation of Radiation Toxicity and Radiation Recall [see Warnings and Precautions ( 5.9 )] 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 Common adverse reactions are: infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, and hepatotoxicity ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy 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 .
8.2Lactation Risk Summary 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. Because of the potential for serious adverse reactions in breastfed infants from dactinomycin, advise women not to breastfeed during treatment with dactinomycin and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose.
8.3Females 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 )] .
8.4Pediatric Use The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies.
8.5Geriatric Use Clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🤰 Pregnancy ▾
8.1Pregnancy 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 .
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dactinomycin have been established in pediatric patients with Wilms tumor, rhabdomyosarcoma, Ewing sarcoma, and metastatic nonseminomatous testicular cancer. The safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. The safety and effectiveness of dactinomycin have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of dactinomycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Dactinomycin exposure-response relationships and the time course of pharmacodynamics response are unknown.
12.3Pharmacokinetics The distribution and excretion of radiolabeled dactinomycin ( 3 H actinomycin D) were assessed in three adult patients with malignant melanoma. Distribution 3 H actinomycin D is concentrated in nucleated cells and does not penetrate the blood-brain barrier. Elimination Excretion Following administration of radiolabeled dactinomycin, approximately 30% was recovered in urine and feces in one week.
Specific Populations Pediatric Patients Published studies and population analyses in patients ≤ 21 years of age with cancer report a trend of increasing systemic dactinomycin clearance with increasing body weight. Drug Interaction Studies Published in vitro studies report that dactinomycin may be a substrate of the P-glycoprotein and OATP1B3 transporter systems.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW 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: NDC Dactinomycin for Injection, USP (500 mcg per vial) Package Factor 71288- 129 -02 500 mcg Single-Dose Vial 1 vial per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and humidity.
Store the reconstituted Dactinomycin for Injection, USP at room temperature for no more than 4 hours from reconstitution to completion of administration [see Dosage and Administration ( 2.7 )] . Dactinomycin for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.
1 Discard unused portion. Lyophilized. Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.
📦 Storage and Handling ▾
Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and humidity. Store the reconstituted Dactinomycin for Injection, USP at room temperature for no more than 4 hours from reconstitution to completion of administration [see Dosage and Administration ( 2.7 )] . Dactinomycin for Injection, USP is a cytotoxic drug.
Follow applicable special handling and disposal procedures. 1 Discard unused portion. Lyophilized.
Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
📋 Description ▾
11 DESCRIPTION Dactinomycin is an actinomycin. Dactinomycin is produced by Streptomyces parvullus . The chemical name is 8-amino-N-(2-amino-4,6-dimethyl-3-oxo-phenoxazin-1-yl)carbonyl-N'-[8-amino-4,6-dimethyl-7-oxo-9-[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0]nonadec-11-yl]carbamoyl]phenoxazin-1-yl]carbonyl-4,6-dimethyl-7-oxo-N,N'-bis[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16 tetrazabicyclo[14.3.0]nonadec-11-yl]-1,9-bis[[3,6,10-trimethyl-7,14-bis(1-methylethyl)-2,5,8,12,15-pentaoxo-9-oxa-3,6,13,16-tetrazabicyclo[14.3.0] nonadec-11-yl]carbamoyl]phenoxazine-1,9-dicarboxamide.
The molecular formula is C 62 H 86 N 12 O 16 and the molecular weight is 1255.42 daltons. The structural formula of dactinomycin is shown below: 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.
Structural Formula of Dactinomycin
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Secondary Malignancy or Leukemia Advise patients of the increased risk of secondary malignancies [see Warnings and Precautions ( 5.1 )] . Veno-occlusive Disease Advise patients about the symptoms of VOD and to seek medical attention if they develop new onset jaundice, abdominal distention, or right upper quadrant pain [see Warnings and Precautions ( 5.2 )] . Myelosuppression Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression or infection [see Warnings and Precautions ( 5.4 )] .
Severe Mucocutaneous Reactions Advise patients of the risk of severe mucocutaneous reactions and to contact their health care provided for new skin lesions, mouth sores or oropharyngeal lesions [see Warnings and Precautions ( 5.5 )] . Renal Toxicity or Hepatotoxicity Advise patients of the need for periodic laboratory testing to monitor for renal toxicity and hepatotoxicity [see Warnings and Precautions ( 5.7 , 5.8 )] . Potentiation of Radiation Toxicity and Radiation Recall Advise patients of the risk of increased radiation-induced gastrointestinal, myelosuppression and skin toxicity [see Warnings and Precautions ( 5.9 )] .
Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.10 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with dactinomycin and for 6 months after final dose [see Use in Specific Populations ( 8.3 )] .
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with dactinomycin and for 3 months after final dose [see Use in Specific Populations ( 8.3 )] . Lactation Advise females not to breastfeed during treatment with dactinomycin and for 14 days after the final dose [see Use in Specific Populations ( 8.2 )] . meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2020 Meitheal Pharmaceuticals Inc. August 2020