Fludarabine Phosphate For Injection, USP

Signal word

WARNING. GHS Class: Reproductive toxicity. Category 2. Reproductive toxicity. Effects on or via lactation.

Hazard statements

Suspected of damaging fertility or the unborn child. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid contact during pregnancy and while nursing. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Wear protective gloves/protective clothing/eye protection/face protection. IF exposed or concerned: Get medical advice/attention. Store locked up. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Emergency Overview: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Eye: Contact with eyes may cause irritation. Signs/Symptoms: Potential adverse reactions from prescribed doses are described in the package insert. Warnings include life-threatening and sometimes fatal autoimmune hemolytic anemia. Adverse effects include: myelosuppression, fever, chills, infection, nausea, vomiting, fatigue, pain, malaise, diaphoresis, alopecia, weakness, paresthesia, headache, cough, pneumonia, dyspnea, diarrhea, anorexia, stomatitis, rash, dysuria, edema, and myalgia. There are clear, dose-dependent toxic effects seen with fludarabine. High doses of fludarabine phosphate have been associated with irreversible central nervous system toxicity characterized by delayed blindness, coma, and death. High doses are also associated with severe thrombocytopenia and neutropenia due to bone marrow suppression. There is no known specific antidote for fludarabine phosphate overdosage. Treatment consists of drug discontinuation and supportive therapy. Fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL) has been associated with a high incidence of fatal pulmonary toxicity in clinical trials, therefore, the use of fludarabine in combination with pentostatin is not recommended. Occupational exposure has not been fully investigated. Aggravation of Pre-Existing Individuals with hypersensitivity to Fludarabine Phosphate for Injection, USP or any of its components. Conditions: