Note: Ingredients listed on restricted chemical lists
EC/CAS
57-50-1
Name of the chemical
Sucrose, pure C12H22O11
Concentration
50-60%
General Information
Revision date
2020-02-04
Product name
REBLOZYL
Product Synonyms
ACE-536
Chemical name
Mixture
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture/Formulated pharmaceutical product of the substance or packaged in final form for patient use; indicated to treat anemia in adult patients mixture and uses with B-thalassemia,
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)
H360D
Hazard statements
Code
Statements
H360D
May damage the unborn child
Section 2
SECTION 2: Hazards identification
(EC) No 1272/2008 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. Consult prescribing/packaging information The classification and labeling listed below is for bulk drug product Globally Harmonized System [GHS] Specific Target Organ Toxicity (repeated exposure) - Category 1. Toxic to Reproduction - Category 1B Celgene #57 - Luspatereept lyophilized cake DP Revision date: 04 February 2020, Version 4.0.0 Page | of 12
Signal word
Danger
Hazard statements
11372 - Causes damage to liver, kidneys, adrenals, and hematopoietic system through prolonged or repeated exposure, H360D - May damage the unborn child. precautions have been read and understood. P260 - Do not breathe dust/mist/ vapors/spray. P281 - Use personal protective equipment as required. P308 + P313. - IF exposed or concerned: get medical advice/attention, P405 - Store locked up. PSO1 - Dispose of contents/container to locat i national/international regulations.
Precautionary statements
—__P201 - Obtain special instructions before use. P202 - Do not handle until all safety
2.3 Other hazards
Luspatercept is a human recombinant fusion protein. It was administered by subcutaneous (SC) injection to healthy volunteers and patients in clinical trials. Common effects in healthy volunteers included injection site reactions (hemorrhage or color change), dry skin, muscle spasms, muscle pain, itchiness, and rash. In patients, bone/musculoskeletal pain, headache, weakness, fever, cold- or flu-like symptoms, fatigue, hypertension, and gastrointestinal upset frequently occurred. 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
