Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
96-98%
General Information
Version
2.0.0
Revision date
2020-03-11
Product name
ZEPOSIATM
Product Synonyms
For ozanimod hydrochloride: RPC1063; 5-(3-{(1S)-1-[(2-hydroxyethyl)amino]-2,3- dihydro-1H-inden-4-yl}-1,2,4-oxadiazol-5-yl)-2-[(propan-2-yl)oxy]benzonitrile,
Chemical name
Mixture - contains a bi-aryl oxadiazole derivative
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 relapsing mixture and uses multiple sclerosis (RMS), as well as for moderate-to-severe inflammatory bowel
1.2.2. Uses advised against
disease (IBD), including ulcerative colitis and Crohn"s disease
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, H372
Hazard statements
Code
Statements
H360D
May damage the unborn child
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 drug product Globally Harmonized System [GHS] Reproductive Toxicity - Category 1B. Specific Target Organ Toxicity (repeated exposure) - Category 1 HAZARDS IDENTIFICATION …continued
Signal word
Danger
Hazard statements
H360D - May damage the unborn child. H372 - Causes damage to bone marrow and lymphoid tissue through prolonged or repeated exposure. Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P281 - Use personal protective equipment as required. P308 + P313 - IF exposed or concerned: get medical advice/attention. 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. P264 -
2.3 Other hazards
Ozamimod is a potent, immunomodulating drug. Adverse effects reported in clinical trials were mild-to-moderate in severity (including headache, upper respiratory and urinary tract infections, back pain, and minor heart rate/blood pressure changes) and their incidence rate was similar to placebo. Increased incidence of local herpes infections were also reported. Note This product/mixture is classified as hazardous under GHS as implemented by
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
