IDHIFATM

Celgene Corporation

Revision date : 2019-05-01

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

232-674-9/9004-34-6

Name of the chemical

cellulose

Concentration

55-60%

General Information

Version

2.1.0

Revision date

2019-05-01

Product name

IDHIFATM

Product Synonyms

For enasidenib: 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-[2- (trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2- yl)amino]propan-2-ol

Chemical name

Mixture - contains a substituted triazine

1.2.1 Relevant identified uses

Bulk formulated pharmaceutical mixture/ Formulated pharmaceutical product/ of the substance or mixture packaged in final form for patient use mixture and uses

Emergency telephone

+1 (800) 424-9300, +1 (703) 527-3887

Icons in SDS

GHS08

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)

H361f, H372

Hazard statements

Code

Statements

H361f

Suspected of damaging fertility

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. Consult prescribing/packaging information The classification and labeling listed below is for bulk drug product HAZARDS IDENTIFICATION …continued Globally Harmonized System [GHS] Specific Target Organ Toxicity (repeated exposure) - Category 1. Reproductive Toxicity - Category 2

Signal word

Danger

Hazard statements

H372 - Causes damage to the immune system through prolonged or repeated exposure. H361f - Suspected of damaging fertility. Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P280 - Wear eye/face protection. P308 + P313 - IF exposed or concerned: get medical advice/attention. P314 - Get medical advice/attention if you feel unwell. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.

Precautionary statements

P260 - Do not breathe dust. P264 - Wash hands thoroughly after handling. P264 -

2.3 Other hazards

Enasidenib is an orally available anticancer drug. The most commonly reported adverse effects in cancer patients were elevated bilirubin, gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea), and decreased appetite. Less frequently albeit more severe adverse effects included leukocytosis (increased white blood cell counts) and differentiation syndrome, including fever, acute kidney failure, dyspnea (shortness of breath), acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. 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

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