General Information
Revision date
2012-11-15
Product name
Vidaza (formulated azacitidine for injection)
Product Synonyms
5-Azacitidine, Azacytidine, 5 AZC, 5-AC, 5-AzaC, 5-AZCR, Antibiotic U 18496, U 18496, WR-183027, NCI-C01569, NSC-102816, 4-amino-1-β-D-ribofuranosyl-s-
Chemical name
Pyrimidine nucleoside analog
CAS No.
320-67-2
1.2.1 Relevant identified uses
Active pharmaceutical ingredient; indicated for the treatment of certain of the substance or myelodysplastic syndromes mixture and uses
Emergency telephone
and Canada
Icons in SDS
Company Information
company name
Celgene Corporation
e-mail address of the competent person responsible for the Safety Data Sheet
MSDScoordinator@Celgene.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H302, H341, H350, H360FD, H372, H400, H410
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
2.1 Classification of the substance or mixture
Regulation (EC) 1272/ Carcinogenic - Category 1B. Germ Cell Mutagenicity - Category 2. Reproductive 2008 [GHS] Toxicity - Category 1B. Acute toxicity - oral - Category 4. Specific Target Organ Toxicity (repeated exposure) - Category 1. Aquatic toxicity (acute) - Category 1. Aquatic toxicity (chronic) - Category 1. Directive 67/548/EEC T - R22, R45 (Carc. Cat. 2), R48/25, R60 (Repr. Cat. 2), R61 (Repr. Cat. 2), R68 or 1999/45/EC (Muta. Cat. 3); N - R50, R50/53 SECTION 2 - HAZARDS IDENTIFICATION …continued
Signal word
Danger Caution US Hazard overview Cytotoxic drug. Suspected Cancer Hazard - May cause cancer. Genotoxic. Reproductive/ Developmental Hazard - May adversely affect the developing fetus or cause adverse reproductive effects. Birth Defect Hazard - May cause birth defects. May cause hematological toxicity, gastrointestinal effects, fever and fatigue. May be harmful if swallowed. Very toxic to aquatic life with long-lasting effects. SECTION 2 - HAZARDS IDENTIFICATION …continued Note This substance is classified as dangerous/hazardous according to Directive 67/548/ EEC, Regulation EC No 1272/2008 (EU CLP), and applicable US regulations. The GHS classifications are based on Regulation (EC) 1272/2008. See Section 16 for full text of EU and GHS classifications.
CLP CLASSIFICATION
H302 - Harmful if swallowed. H341 - Suspected of causing genetic defects. H350
Hazard statements
May cause cancer. H360FD - May damage fertility. May damage the unborn child. H372 - Causes damage to hematological and gastrointestinal systems through prolonged or repeated exposure. H400 - Very toxic to aquatic life. H410 - Very toxic to aquatic life with long-lasting effects. CLP/GHS P201 - Obtain special instructions before use. P202 - Do not handle until all safety
Precautionary statements
precautions have been read and understood. P260 - Do not breathe dust. P264 Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P281 - Use personal protective equipment as required. P308 + P313 - If exposed or concerned: get medical advice/attention. P301+P312 IF SWALLOWED Call a Poison Center or doctor/physician if you feel unwell. P314 - Get medical advice/attention if you feel unwell. P330 - Rinse mouth. P391 - Collect spillage. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/ national/international regulations.
2.3 Other hazards
The most commonly occurring adverse effects with therapeutic use include hematological toxicity (e.g., thrombocytopenia, anemia, neutropenia), fever, gastrointestinal effects (e.g., nausea, vomiting, diarrhea, constipation), fatigue, injection site erythema, ecchymosis (skin discoloration caused by escape of blood into tissues from ruptured blood vessels). Other effects may include hypotension, shortness of breath, liver/kidney toxicity and electrolyte abnormalities. Post- marketing reports of interstitial lung disease and tumor lysis syndrome may also be azacitidine-related.
