DACTINOMYCIN

Dactinomycin is used in combination with other agents to treat Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma, and metastatic nonseminomatous testicular cancer. It is also used as a single agent or in combination with other agents to treat gestational trophoblastic neoplasia (Prod Info Cosmegen(R) intravenous injection, 2012).
Dactinomycin is also indicated for palliative or adjunctive therapy, as a regional perfusion of locally recurrent solid malignancies (Prod Info Cosmegen(R) intravenous injection, 2012).

FORMS

Dactinomycin is available as a sterile lyophilized powder for injection after reconstitution. Each vial contains 0.5 mg of dactinomycin and 20 mg of mannitol (Prod Info Cosmegen(R) intravenous injection, 2012).

SOURCES

Dactinomycin, an antineoplastic agent, is the principal component of a mixture of actinomycin antibiotics produced by Streptomyces parvulus (Budavari, 1996).

-CLINICAL EFFECTS

GENERAL CLINICAL EFFECTS

USES: Dactinomycin is used in combination with other agents to treat Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma, and metastatic nonseminomatous testicular cancer. It is also used as a single agent or in combination with other agents to treat gestational trophoblastic neoplasia. Dactinomycin is also indicated for palliative or adjunctive therapy, as a regional perfusion of locally recurrent solid malignancies.

PHARMACOLOGY: Dactinomycin is classified as an antibiotic but is not used as an antimicrobial agent. It is considered to be cell cycle–phase nonspecific. Its antineoplastic action may involve binding to DNA by intercalation between base pairs and inhibition of DNA-dependent RNA synthesis.

EPIDEMIOLOGY: Overdose is rare.

WITH POISONING/EXPOSURE

Dactinomycin overdose information is limited. The following effects may occur following an overdose: Nausea, vomiting, diarrhea, mucositis, stomatitis, gastrointestinal ulceration, severe skin disorders (eg, skin exfoliation, exanthema, desquamation and epidermolysis), seizures, choreoathetosis of extremities, muscle weakness, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, severe hematopoietic depression (eg, anemia, and thrombocytopenia), veno-occlusive disease, acute renal failure, sepsis (including neutropenic sepsis) with fatal outcome. A 10-fold overdose in an 18-month-old child resulted in hypotension, pancytopenia, acute renal failure, pancreatitis, and severe mucositis.
INADVERTENT INTRATHECAL EXPOSURE: Hypotonia, hyperreflexia, respiratory failure, lower extremity paraplegia, paraparesis of the upper extremities, bladder sphincter impairment, and respiratory insufficiency developed in a child following the inadvertent intrathecal administration of dactinomycin. Despite aggressive supportive care, persistent paraplegia developed.

WITH THERAPEUTIC USE

The dose-limiting toxicity of dactinomycin is myelosuppression. It may be apparent 1 to 7 days after dactinomycin therapy and may initially manifest as thrombocytopenia. Platelet and white cell nadir counts will generally occur within 14 to 21 days following chemotherapy, with recovery in 21 to 25 days. Anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia have been reported in patients receiving dactinomycin. Other adverse effects include alopecia, skin eruptions, erythema, Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, dermatitis, hyperpigmentation, hypocalcemia, severe nausea and vomiting, anorexia, abdominal pain, diarrhea, mucositis, gastrointestinal ulceration, elevated liver enzymes, ascites, hepatomegaly, hepatitis, hepatic failure, hepatic veno-occlusive diseases, myalgia, malaise, fatigue, lethargy, pneumonitis, sepsis, (including neutropenic sepsis) with fatal outcome. Dactinomycin is extremely corrosive. Extravasation during intravenous administration may result in severe damage to soft tissues.

Editor's Note: An ERG guide with information appropriate to this material does not exist.

ACUTE CLINICAL EFFECTS

SUMMARY

PHARMACOLOGY: Dactinomycin is classified as an antibiotic but is not used as an antimicrobial agent. It is considered to be cell cycle–phase nonspecific. Its antineoplastic action may involve binding to DNA by intercalation between base pairs and inhibition of DNA-dependent RNA synthesis.
EPIDEMIOLOGY: Overdose is rare.
OVERDOSE

Dactinomycin overdose information is limited. The following effects may occur following an overdose: Nausea, vomiting, diarrhea, mucositis including stomatitis, gastrointestinal ulceration, severe skin disorders including skin exfoliation, exanthema, desquamation and epidermolysis, seizures, choreoathetosis of extremities, muscle weakness, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia, severe hematopoietic depression (eg, anemia, and thrombocytopenia), veno-occlusive disease, acute renal failure, sepsis (including neutropenic sepsis) with fatal outcome. A 10-fold overdose in an 18-month-old child resulted in hypotension, pancytopenia, acute renal failure, pancreatitis, and severe mucositis.
INADVERTENT INTRATHECAL EXPOSURE: Hypotonia, hyperreflexia, respiratory failure, lower extremity paraplegia, paraparesis of the upper extremities, bladder sphincter impairment, and respiratory insufficiency developed in a child following the inadvertent intrathecal administration of dactinomycin. Despite aggressive supportive care, persistent paraplegia developed.

ADVERSE EFFECTS

The dose-limiting toxicity of dactinomycin is myelosuppression. It may be apparent 1 to 7 days after dactinomycin therapy and may initially manifest as thrombocytopenia. Platelet and white cell nadir counts will generally occur within 14 to 21 days following chemotherapy, with recovery in 21 to 25 days. Anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia have been reported in patients receiving dactinomycin. Other adverse effects include alopecia, skin eruptions, erythema, Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, dermatitis, hyperpigmentation, hypocalcemia, severe nausea and vomiting, anorexia, abdominal pain, diarrhea, mucositis, gastrointestinal ulceration, elevated liver enzymes, ascites, hepatomegaly, hepatitis, hepatic failure, hepatic veno-occlusive diseases, myalgia, malaise, fatigue, lethargy, pneumonitis, sepsis, (including neutropenic sepsis) with fatal outcome. Dactinomycin is extremely corrosive. Extravasation during intravenous administration may result in severe damage to soft tissues.

CARDIOVASCULAR

HYPOTENSION: An 18-month-old child developed hypotension refractory to dopamine and norepinephrine therapy 11 days after receiving a 10-fold overdose of dactinomycin for 3 days (0.15 mg/kg/day instead of the prescribed 0.015 mg/kg/day). Hypotension resolved after administration of hydrocortisone (40 mg/m(2)/day), amid concerns of hypoadrenalism (Brogan et al, 1999).

DERMATOLOGIC

Dactinomycin therapy has been associated with skin eruptions, erythema, and increased pigmentation of previously irradiated skin (Prod Info Cosmegen(R) intravenous injection, 2012; Coppes et al, 1997) and has been reported to potentiate dermatologic adverse effects of ionizing radiation (Blatt et al, 1981). Epidermolysis and erythema have been reported with regional limb perfusion (Prod Info Cosmegen, 2002).
During postmarketing experience, Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) were observed in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).
EXTRAVASATION INJURY: Dactinomycin is extremely corrosive, and extravasation during IV administration can result in cellulitis and damage to soft tissues. In one case, extravasation led to contracture of the arms (Prod Info Cosmegen(R) intravenous injection, 2012).

ELECTROLYTES

HYPOCALCEMIA: Hypocalcemia has been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).
CASE REPORT: A 17-year-old, with orbitobasal rhabdomyosarcoma, developed hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia (128, 2.7, 1.83, and 0.44 mmol/l, respectively) after receiving a 2.5 mg dose of dactinomycin 24 hours after receiving a 2.5 mg dose as part of his normal chemotherapeutic regimen. The total dose of dactinomycin received was 0.1 mg/kg (3.3 mg/m(2)). The electrolytes normalized following intravenous supplementation (Choonara et al, 1988).

GASTROINTESTINAL

NAUSEA AND VOMITING: Severe nausea and vomiting can occur within a few hours following dactinomycin therapy (Prod Info Cosmegen(R) intravenous injection, 2012).
OTHER EFFECTS: Anorexia, abdominal pain, diarrhea, stomatitis, and gastrointestinal ulcerations have been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).
PANCREATITIS: CASE REPORT: An 18-month-old child developed pancreatitis after inadvertently receiving a 10-fold overdose of dactinomycin for 3 days (0.15 mg/kg/day instead of the prescribed 0.015 mg/kg/day) (Brogan et al, 1999).

GENITOURINARY

ACUTE RENAL FAILURE: CASE REPORT: An 18-month-old child developed acute anuric renal failure 9 days after receiving a 10-fold overdose of dactinomycin for 3 days (0.15 mg/kg/day instead of the prescribed 0.015 mg/kg/day). Continuous venovenous hemofiltration was performed and the patient gradually recovered 13 days after onset of symptoms (Brogan et al, 1999).

HEMATOLOGIC

MYELOSUPPRESSION: The dose-limiting toxicity of dactinomycin is myelosuppression. It may be apparent 1 to 7 days after dactinomycin therapy and may initially manifest as thrombocytopenia. Platelet and white cell nadir counts will generally occur within 14 to 21 days following chemotherapy, with recovery in 21 to 25 days (Sweetman, 2004; Blumenreich et al, 1985). Anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, reticulocytopenia, neutropenia, febrile neutropenia have been reported in patients receiving dactinomycin. Recovery may take up to 3 weeks (Prod Info Cosmegen(R) intravenous injection, 2012).
Dactinomycin may trigger an immune mechanism with the formation of platelet antibodies, thus leading to thrombocytopenia. Treatment with prednisone appeared to improve platelet counts in several patients (Khatua et al, 2004; Shannon et al, 2003; Hara et al, 1986; Hodder et al, 1985).

HEPATIC

Elevated liver enzymes, ascites, hepatomegaly, hepatitis, hepatic failure, and hepatic veno-occlusive diseases have been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).

MUSCULOSKELETAL

MYALGIA: Myalgia has been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).

NEUROLOGIC

Malaise, fatigue, and lethargy have been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).
CASE REPORT: Inadvertent intrathecal administration of 350 mcg dactinomycin instead of 12 mg of methotrexate occurred in a 5-year-old child with stage I T-cell lymphoblastic lymphoma. She developed hypotonia, hyperreflexia, respiratory failure, lower extremity paraplegia, paraparesis of the upper extremities, bladder sphincter impairment, and respiratory insufficiency. Despite aggressive supportive care (sedation, cerebrospinal fluid (CSF) exchange, CSF perfusion, intrathecal corticosteroids and ascorbic acid, intravenous sodium thiosulfate) and eventual hospital discharge, paraplegia of the lower extremities, paresis of the upper extremities, and bladder sphincter impairment continued to persist. It is believed that the patient's neurotoxicity was due to the necrotizing effects of dactinomycin (Kavan et al, 2001).
SEIZURES: CASE REPORT: A 17-year-old male experienced a generalized seizure after inadvertently receiving a 2.5-mg dose of dactinomycin 24 hours after receiving a 2.5-mg dose as part of his normal chemotherapeutic regimen. He recovered following intravenous administration of diazepam (Choonara et al, 1988).

RESPIRATORY

PNEUMONITIS: Pneumonitis has been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).

OTHER

Sepsis (including neutropenic sepsis) with fatal outcome has been reported in patients receiving dactinomycin (Prod Info Cosmegen(R) intravenous injection, 2012).

CHRONIC CLINICAL EFFECTS

Most or all of the effects listed in the ACUTE EXPOSURE section above would also apply to chronic exposure, because the standard therapeutic regimen of dactinomycin involves multiple doses.

ANIMAL STUDY: Dogs given an IV dose of 15 mcg/kg for 5 days developed anorexia, vomiting, dehydration, hemorrhages and/or ulcers in the intestine and colon, and damage to the lymphoid, blood-forming, and intestinal tissues (HSDB , 1996).

-FIRST AID

FIRST AID AND PREHOSPITAL TREATMENT

Gastrointestinal decontamination is not recommended; dactinomycin is only available parenterally.

-RANGE OF TOXICITY

MAXIMUM TOLERATED EXPOSURE

CASE REPORT: Inadvertent intrathecal administration of 350 mcg dactinomycin instead of 12 mg of methotrexate occurred in a 5-year-old child with stage I T-cell lymphoblastic lymphoma, resulting in hypotonia, hyperreflexia, lower extremity paraplegia, paraparesis of the upper extremities, bladder sphincter impairment, and respiratory insufficiency. Despite aggressive supportive care and eventual hospital discharge, paraplegia of the lower extremities, paresis of the upper extremities, and bladder sphincter impairment continued to persist (Kavan et al, 2001).

CASE REPORT: An 18-month-old child inadvertently received a 10-fold overdose of dactinomycin (0.15 mg/kg/day for 3 days instead of the prescribed 0.015 mg/kg/day). She developed hypotension, pancytopenia, acute renal failure, choreoathetosis and right arm weakness, pancreatitis, and severe mucositis. The child gradually recovered with residual functional impairment of his right arm (Brogan et al, 1999).

CASE REPORT: A 17-year-old, with orbitobasal rhabdomyosarcoma, developed electrolyte abnormalities, severe mucositis and diarrhea, pancytopenia, generalized edema, and dermatitis after receiving a second 2.5-mg dose of dactinomycin 24 hours after receiving a 2.5-mg dose as part of his normal chemotherapeutic regimen. He gradually recovered with supportive care (Choonara et al, 1988).

Carcinogenicity Ratings for CAS50-76-0 :

ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
EPA (U.S. Environmental Protection Agency, 2011): Not Listed
IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): 3 ; Listed as: Actinomycin D

3 : The agent (mixture or exposure circumstance) is not classifiable as to its carcinogenicity to humans. This category is used most commonly for agents, mixtures and exposure circumstances for which the evidence of carcinogenicity is inadequate in humans and inadequate or limited in experimental animals. Exceptionally, agents (mixtures) for which the evidence of carcinogenicity is inadequate in humans but sufficient in experimental animals may be placed in this category when there is strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans. Agents, mixtures and exposure circumstances that do not fall into any other group are also placed in this category.

NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
MAK (DFG, 2002): Not Listed
NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

TOXICITY AND RISK ASSESSMENT VALUES

EPA IRIS

EPA Risk Assessment Values for CAS50-76-0 (U.S. Environmental Protection Agency, 2011):

Not Listed

TOXICITY VALUES

LD50- (INTRAPERITONEAL)MOUSE:
- 500 to 750 mcg/kg (RTECS, 2004)
LD50- (INTRAVENOUS)MOUSE:
- 1025 mcg/kg (RTECS, 2004)
LD50- (ORAL)MOUSE:
- 13 to 20 mg/kg (RTECS, 2004)
LD50- (SUBCUTANEOUS)MOUSE:
- 500 mcg/kg (RTECS, 2004)
LD50- (INTRAPERITONEAL)RAT:
- 100 mcg/kg (RTECS, 2004)
LD50- (INTRAVENOUS)RAT:
- 460 mcg/kg (RTECS, 2004)
LD50- (ORAL)RAT:
- 7200 mcg/kg (RTECS, 2004)
LD50- (SUBCUTANEOUS)RAT:
- 800 mcg/kg (RTECS, 2004)

-STANDARDS AND LABELS

WORKPLACE STANDARDS

ACGIH TLV Values for CAS50-76-0 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

AIHA WEEL Values for CAS50-76-0 (AIHA, 2006):

Not Listed

NIOSH REL and IDLH Values for CAS50-76-0 (National Institute for Occupational Safety and Health, 2007):

Not Listed

OSHA PEL Values for CAS50-76-0 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS50-76-0 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

ENVIRONMENTAL STANDARDS

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS50-76-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS50-76-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA RCRA Hazardous Waste Number for CAS50-76-0 (U.S. Environmental Protection Agency, 2010b):

Not Listed
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA SARA Title III, Extremely Hazardous Substance List for CAS50-76-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA SARA Title III, Community Right-to-Know for CAS50-76-0 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

DOT List of Marine Pollutants for CAS50-76-0 (49 CFR 172.101 - App. B, 2005):

Not Listed

EPA TSCA Inventory for CAS50-76-0 (EPA, 2005):

Not Listed

LABELS

NFPA

NFPA Hazard Ratings for CAS50-76-0 (NFPA, 2002):

Not Listed

-PERSONAL PROTECTION

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

PROTECTIVE CLOTHING

CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 50-76-0.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

-PHYSICAL HAZARDS

FIRE HAZARD

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

FLAMMABILITY CLASSIFICATION

NFPA Flammability Rating for CAS50-76-0 (NFPA, 2002):

Not Listed

FIRE CONTROL/EXTINGUISHING AGENTS

Editor's Note: An ERG guide with information appropriate to this material does not exist.

NFPA Extinguishing Methods for CAS50-76-0 (NFPA, 2002):

Not Listed

EVACUATION PROCEDURES

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

AIHA ERPG Values for CAS50-76-0 (AIHA, 2006):

Not Listed

DOE TEEL Values for CAS50-76-0 (U.S. Department of Energy, Office of Emergency Management, 2010):

Not Listed

AEGL Values for CAS50-76-0 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; United States Environmental Protection Agency Office of Pollution Prevention and Toxics, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):

Not Listed

NIOSH IDLH Values for CAS50-76-0 (National Institute for Occupational Safety and Health, 2007):

Not Listed

CONTAINMENT/WASTE TREATMENT OPTIONS

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

SMALL LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

LARGE LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-PHYSICAL/CHEMICAL PROPERTIES

MOLECULAR WEIGHT

1255.4 (Sweetman, 2004)

DESCRIPTION/PHYSICAL STATE

Dactinomycin is a yellow to orange lyophilized powder (Prod Info COSMEGEN(R) intravenous injection, 2008) that is soluble in water at 10 degrees C, slightly soluble in water at 37 degrees C, freely soluble in alcohol, and very slightly soluble in ether (Sweetman, 2004).

5.5 to 7.9 (reconstituted solution) (Trissel, 1983)

-REFERENCES

GENERAL BIBLIOGRAPHY

40 CFR 372.28: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Lower thresholds for chemicals of special concern. National Archives and Records Administration (NARA) and the Government Printing Office (GPO). Washington, DC. Final rules current as of Apr 3, 2006.

40 CFR 372.65: Environmental Protection Agency - Toxic Chemical Release Reporting, Community Right-To-Know, Chemicals and Chemical Categories to which this part applies. National Archives and Records Association (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Apr 3, 2006.

49 CFR 172.101 - App. B: Department of Transportation - Table of Hazardous Materials, Appendix B: List of Marine Pollutants. National Archives and Records Administration (NARA) and the Government Printing Office (GPO), Washington, DC. Final rules current as of Aug 29, 2005.

62 FR 58840: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 1997.

65 FR 14186: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

65 FR 39264: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

65 FR 77866: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2000.

66 FR 21940: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2001.

67 FR 7164: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2002.

68 FR 42710: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2003.

69 FR 54144: Notice of the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances - Proposed AEGL Values, Environmental Protection Agency, NAC/AEGL Committee. National Archives and Records Administration (NARA) and the Government Publishing Office (GPO), Washington, DC, 2004.

AIHA: 2006 Emergency Response Planning Guidelines and Workplace Environmental Exposure Level Guides Handbook, American Industrial Hygiene Association, Fairfax, VA, 2006.

AMA Department of DrugsAMA Department of Drugs: AMA Evaluations Subscription, American Medical Association, Chicago, IL, 1992.

Addiego JE, Ridgway D, & Bleyer WA: The acute management of intrathecal methotrexate overdose: pharmacologic rationale and guidelines. J Pediatr 1981; 98(5):825-828.

American Conference of Governmental Industrial Hygienists : ACGIH 2010 Threshold Limit Values (TLVs(R)) for Chemical Substances and Physical Agents and Biological Exposure Indices (BEIs(R)), American Conference of Governmental Industrial Hygienists, Cincinnati, OH, 2010.

Arndt C, Hawkins D, Anderson JR, et al: Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol 2004; 22:1894-1901.

Bakri UN, Pedersen P, & Nassar M: Normal pregnancy after curative multiagent chemotherapy for choriocarcinoma with brain metastases. Acta Obstet Gynecol Scand 1991; 70:611-613.

Bensinger W, Schubert M, Ang KK, et al: NCCN Task Force Report. prevention and management of mucositis in cancer care. J Natl Compr Canc Netw 2008; 6 Suppl 1:S1-21.

Blaney SM, Poplack DG, Godwin K, et al: Effect of body position on ventricular CSF methotrexate concentration following intralumbar administration. J Clin Oncol 1995; 13(1):177-179.

Blatt J & Lee PA: Severe acne and hyperandrogenemia following dactinomycin. Med Pediatr Oncol 1993; 21:373-374.

Blatt J, Trigg ME, Pizzo PA, et al: Tolerance to single-dose dactinomycin in combination chemotherapy for solid tumors. Cancer Treat Rep 1981; 65:145-147.

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