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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

Study: 93 percent of advanced leukemia patients in remission after immunotherapy
Source: Cancer / Oncology News From Medical News Today [2016.04.28]
'Extraordinary' but short-term results from early-stage trial of engineered immune cells.

Risk factors identified for acute pancreatitis that can disrupt leukemia treatment
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.26]
Researchers have identified a rare genetic variation associated with a dramatically increased risk of severe acute pancreatitis in acute lymphoblastic leukemia (ALL) patients treated with the...

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.12]
The U.S. Food and Drug Administration has approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p...

New mouse model for acute myeloid leukemia opens door to research, possible treatments
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.03.31]
A novel mouse model of a highly lethal form of acute myeloid leukemia (AML) offers a new tool for scientists working to better understand this disease and research new therapeutic targets.

Leukemia study reveals role of RNA binding protein in driving cancer
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.03.15]
Abnormally expressed in cancer cells, the protein was found to promote the proliferation of B cells in B-cell acute lymphoblastic leukemia.

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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: 2016-04-28

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