Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
30%
EC/CAS
209-150-3
Name of the chemical
Aluminium, zinc, magnesium and calcium stearates
Concentration
2%
General Information
Version
5.0.0
Revision date
2020-08-17
Product name
Onureg
Product Synonyms
Formulated azacitidine for oral administration; CC-486
Chemical name
Mixture - contains pyrimidine nucleoside analog
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical product/ Formulated pharmaceutical product of the substance or packaged in final form for patient use; indicated for the treatment of certain mixture and uses myelodysplastic syndromes
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
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)
H341, H350, H360FD, H372, H400, H410
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk azacitidine tablets Globally Harmonized System [GHS] Carcinogenic - Category 1B. Germ Cell Mutagenicity - Category 2. Reproductive Toxicity - Category 1B. Specific Target Organ Toxicity (repeated exposure) - Category 1. Aquatic toxicity (acute) - Category 1. Aquatic toxicity (chronic) - Category 1 HAZARDS IDENTIFICATION …continued
Signal word
Danger
Hazard statements
H341 - Suspected of causing genetic defects. H350 - 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. 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. P391 - Collect spillage. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.
Precautionary statements
P201 - Obtain special instructions before use. P260 - Do not breathe dust. P270 -
2.3 Other hazards
In a clinical trial with oral azacitidine, headache, vomiting and hypotension were reported in more than one patient. Gastrointestinal (GI) effects (e.g., nausea, diarrhea, constipation, upset stomach), fatigue, dizziness and headache, and decreased hemoglobin levels were also noted. A similar spectrum of adverse effects occurs with therapeutic use of azacitidine for injection (e.g., thrombocytopenia, anemia, neutropenia, fever, GI effects, fatigue) in addition to injection site effects. 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. Note This mixture is classified as hazardous under GHS as implemented by Regulation
2.1 Classification of the substance or mixture
Drugs in the finished state and intended for the final user are not subject to substance or mixture
