Note: Ingredients listed on restricted chemical lists
EC/CAS
200-711-8/69-65-8
Name of the chemical
D-mannitol C6H14O6
Concentration
1-5%
General Information
Version
1.1.0
Revision date
2017-11-13
Product name
Fludarabine Phosphate for Injection, USP
Product name
Fludarabine Phosphate for Injection, USP
Identification on the label/Trade name
None identified
Product Synonyms
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)
Chemical name
Purine Nucleoside
1.2.1 Relevant identified uses
Bulk pharmaceutical product; indicated for the treatment of cancer of the substance or mixture and uses
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
Leucadia Pharmaceuticals, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
info.sds@leucadiapharma.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H351, H360D
Hazard statements
Code
Statements
H351
Suspected of causing cancer
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 Globally Harmonized System [GHS] Reproductive Toxicity - Category 1B. Carcinogenic - Category 2
2.2 Label elements
SECTION 2 - HAZARDS IDENTIFICATION …continued
Signal word
Danger
Hazard statements
H360D - May damage the unborn child. H351 - Suspected of causing cancer. 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. P281 - Use personal protective
2.3 Other hazards
Fludarabine phosphate is a prodrug indicated for the treatment of chronic lymphocytic leukemia (CLL). Although the mechanism is not fully understood, the active metabolite appears to inhibit DNA synthesis. The most commonly reported adverse effects include myelosuppression (low red or white blood cell counts) leading to decreased resistance to infection, cough, fever, fatigue, weakness, and gastrointestinal upset (nausea, vomiting, diarrhea). Other commonly reported adverse effects include chills, edema, malaise, peripheral neuropathy (tingling, numbness, or pain in the extremities), visual disturbance, anorexia, mucositis (GI tract inflammation/ulceration), stomatitis (sore and inflamed mouth), and skin rash. Serious opportunistic infections have been reported. 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
