Note: Ingredients listed on restricted chemical lists
General Information
Version
4.0.0
Revision date
2020-04-08
Product name
InrebicTM [Serial Number 86690908;
Product Synonyms
Fedratinib Capsules, 100 mg; Containing 100-mg fedratinib free base (equivalent to 117.3 mg fedratinib dihydrochloride monohydrate) per capsule
Chemical name
Mixture - contains a sulfonamide
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; indicated for the treatment of cancer mixture and uses
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)
H361d, H372
Hazard statements
Code
Statements
H361d
Suspected of damaging 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 HAZARDS IDENTIFICATION …continued Globally Harmonized Reproductive Toxicity - Category 2. Specific Target Organ Toxicity (repeated System [GHS] exposure) - Category 1
Signal word
Danger
Hazard statements
H361d - Suspected of damaging the unborn child. H372 - Causes damage to lymphatic system, bone marrow, liver, heart, skeletal muscle, and lungs through prolonged or repeated exposure. 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. 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. P202 - Do not handle until all safety
2.3 Other hazards
Fedratinib is a Janus Associated Kinase 2 (JAK2) and fibromyalgia syndrome (FMS)-like receptor tyrosine kinase 3 (FLT3) inhibitor. In clinical trials, the most commonly reported adverse effects in healthy volunteers included mild gastrointestinal (GI) disorders (diarrhea, nausea, vomiting). Similar GI effects, clinical chemistry changes, decreased blood cell counts (red blood cell counts and platelets), and encephalopathy, which were sometimes serious and/or fatal, were frequently noted in patients with myelofibrosis. 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
