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Fludarabine Injection (Fludarabine Phosphate Injection) - Summary

 
 



WARNING

Fludarabine Phosphate for Injection, USP should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine Phosphate for Injection, USP can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, Fludarabine Phosphate for Injection, USP was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with Fludarabine Phosphate for Injection, USP. Patients undergoing treatment with Fludarabine Phosphate for Injection, USP should be evaluated and closely monitored for hemolysis.

In a clinical investigation using Fludarabine Phosphate for Injection, USP in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of Fludarabine Phosphate for Injection, USP in combination with pentostatin is not recommended.

 

SUMMARY

Fludarabine Phosphate for Injection, USP contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine.

Fludarabine Phosphate for Injection, USP is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate for Injection, USP in previously untreated or non-refractory patients with CLL have not been established.


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NEWS HIGHLIGHTS

Media Articles Related to Fludarabine Injection

In highly lethal type of leukemia, cancer gene predicts treatment response
Source: Cancer / Oncology News From Medical News Today [2016.11.25]
Patients with the most lethal form of acute myeloid leukemia (AML) - based on genetic profiles of their cancers - typically survive for only four to six months after diagnosis, even with aggressive...

Potential targeted therapy found for newly identified leukemia subtype with poor outcome
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.11.10]
An international research team led by St. Jude Children's Research Hospital investigators has uncovered details of a new, high-risk subtype of acute lymphoblastic leukemia (ALL) as well as a...

Genetic hallmarks of acute lymphoblastic leukemia subtype uncovered
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.10.25]
St. Jude Children's Research Hospital - Washington University Pediatric Cancer Genome Project team identifies genetic changes underlying a type of B-precursor acute lymphoblastic leukemiaAn...

Low cost method for examining single leukemia cells could transform treatment
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.10.18]
Leukemia is a disease in which each cell can exhibit different genetic traits, and now Swedish researchers have found a cheap way to examine the individual cells.

New treatment approach for leukemia renders cancer genes powerless
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.10.14]
In leukemia cells it is often the case that genes are reactivated that, in physiological terms, mediate the self-renewal of blood stem cells.

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Published Studies Related to Fludarabine Injection

Clofarabine +/- fludarabine with once daily i.v. busulfan as pretransplant conditioning therapy for advanced myeloid leukemia and MDS. [2011.06]
Although a combination of i.v...

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Clinical Trials Related to Fludarabine Injection

Fludarabine, Bendamustine, and Rituximab (FBR) in Chronic Lymphocytic Leukemia (CLL) [Active, not recruiting]
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.

Fludarabine/Clofarabine/Busulfan Combined With SAHA in Acute Leukemia [Recruiting]
The goal of this clinical research study is to evaluate the safety of combining vorinostat (also called SAHA) with fludarabine, clofarabine, and busulfan.

Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) [Recruiting]
The goal of this clinical research study is to compare how well two different schedules of giving busulfan with fludarabine and cladribine before a stem cell transplant in patients with AML or MDS may help to control the disease. The safety of this drug combination will also be studied.

Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients [Completed]
This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx [Completed]
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.

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Page last updated: 2016-11-25

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