LETROZOLE
HAZARDTEXT ®
Information to help in the initial response for evaluating chemical incidents
-IDENTIFICATION
SYNONYMS
IDENTIFIERS
USES/FORMS/SOURCES
Letrozole is used for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received 5 years of adjuvant tamoxifen therapy. It is also used for the first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. In addition, letrozole is used for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy (Prod Info letrozole oral tablets, 2011).
-CLINICAL EFFECTS
GENERAL CLINICAL EFFECTS
- USES: Letrozole is used to treat postmenopausal women with breast cancers.
- PHARMACOLOGY: Letrozole is a nonsteroidal competitive inhibitor of aromatase and thus, in postmenopausal women, inhibits conversion of adrenal androgens (primarily androstenedione and testosterone) to estrogens (estrone and estradiol) in peripheral tissues and cancer tissue. As a result, letrozole interferes with estrogen-induced stimulation or maintenance of growth of hormonally responsive (estrogen and/or progesterone receptor positive or receptor unknown) breast cancers.
- EPIDEMIOLOGY: Overdose is rare.
COMMON (more than 20%): Hot flashes, arthralgia, flushing, asthenia, edema, bone pain, headache, dizziness, hypercholesterolemia, and increased sweating. OTHER EFFECTS: Nausea, vomiting, diarrhea, anorexia, dyspepsia, abdominal pain, constipation, hypertension, chest pain, rash, alopecia, vaginal discharge, bleeding, and irritation, urinary tract infection, elevated liver enzymes, muscle pain, joint pain, back pain, limb pain, fatigue, insomnia, dyspnea, and cough. Pancytopenia, leukopenia, and peripheral thromboembolic events, such as venous thrombosis, thrombophlebitis, portal vein thrombosis, and pulmonary embolism have rarely been reported in clinical trials and postmarketing reports, however, cause and effect relationships have not been established. Letrozole is classified as pregnancy category X.
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
-FIRST AID
FIRST AID AND PREHOSPITAL TREATMENT
-RANGE OF TOXICITY
MINIMUM LETHAL EXPOSURE
MICE AND RATS: Lethality was observed in both animals following single oral doses that were equal to or greater than 2000 mg/kg (about 4000 to 8000 times the daily maximum recommended human dose on a mg/m2 basis). Symptoms observed prior to death were reduced motor activity, ataxia, and dyspnea (Prod Info letrozole oral tablets, 2011).
MAXIMUM TOLERATED EXPOSURE
In isolated cases of letrozole overdose, the highest single dose of 62.5 mg or 25 tablets did not result in serious adverse effects (Prod Info letrozole oral tablets, 2011). In clinical studies, single dose trials up to 30 mg and multiple dose trials of 10 mg have been well tolerated (Prod Info letrozole oral tablets, 2011).
- Carcinogenicity Ratings for CAS112809-51-5 :
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): Not Listed 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 Risk Assessment Values for CAS112809-51-5 (U.S. Environmental Protection Agency, 2011):
-STANDARDS AND LABELS
WORKPLACE STANDARDS
- ACGIH TLV Values for CAS112809-51-5 (American Conference of Governmental Industrial Hygienists, 2010):
- AIHA WEEL Values for CAS112809-51-5 (AIHA, 2006):
- NIOSH REL and IDLH Values for CAS112809-51-5 (National Institute for Occupational Safety and Health, 2007):
- OSHA PEL Values for CAS112809-51-5 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
- OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS112809-51-5 (U.S. Occupational Safety and Health Administration, 2010):
ENVIRONMENTAL STANDARDS
- EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS112809-51-5 (U.S. Environmental Protection Agency, 2010):
- EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS112809-51-5 (U.S. Environmental Protection Agency, 2010):
- EPA RCRA Hazardous Waste Number for CAS112809-51-5 (U.S. Environmental Protection Agency, 2010b):
- EPA SARA Title III, Extremely Hazardous Substance List for CAS112809-51-5 (U.S. Environmental Protection Agency, 2010):
- EPA SARA Title III, Community Right-to-Know for CAS112809-51-5 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):
- DOT List of Marine Pollutants for CAS112809-51-5 (49 CFR 172.101 - App. B, 2005):
- EPA TSCA Inventory for CAS112809-51-5 (EPA, 2005):
LABELS
- NFPA Hazard Ratings for CAS112809-51-5 (NFPA, 2002):
-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 112809-51-5.
-PHYSICAL HAZARDS
FIRE HAZARD
- FLAMMABILITY CLASSIFICATION
- NFPA Flammability Rating for CAS112809-51-5 (NFPA, 2002):
- FIRE CONTROL/EXTINGUISHING AGENTS
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
- NFPA Extinguishing Methods for CAS112809-51-5 (NFPA, 2002):
EVACUATION PROCEDURES
- Editor's Note: An ERG guide with information appropriate to this material does not exist.
- AIHA ERPG Values for CAS112809-51-5 (AIHA, 2006):
- DOE TEEL Values for CAS112809-51-5 (U.S. Department of Energy, Office of Emergency Management, 2010):
- AEGL Values for CAS112809-51-5 (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; 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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):
- NIOSH IDLH Values for CAS112809-51-5 (National Institute for Occupational Safety and Health, 2007):
CONTAINMENT/WASTE TREATMENT OPTIONS
-PHYSICAL/CHEMICAL PROPERTIES
MOLECULAR WEIGHT
- 285.31 (Prod Info FEMARA(R) oral tablets, 2010)
DESCRIPTION/PHYSICAL STATE
- A white to yellowish crystalline and practically odorless powder that is freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. Melting range is between 184 and 185 degrees C (Prod Info FEMARA(R) oral tablets, 2010).
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