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.
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.
Media Articles Related to Fludarabine Injection
Experimental Immune Cell Rx Shows Promise for Leukemia
Source: MedicineNet Leukemia Specialty [2016.09.22]
Title: Experimental Immune Cell Rx Shows Promise for Leukemia
Category: Health News
Created: 9/21/2016 12:00:00 AM
Last Editorial Review: 9/22/2016 12:00:00 AM
Brain cancer and leukemia: New molecular mechanisms decoded
Source: Cancer / Oncology News From Medical News Today [2016.09.16]
A joint research published in Nature Communications has shown new molecular causes of brain cancer and leukemia.
Many adolescent girls with leukemia are not being screened for pregnancy before beginning chemotherapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.09.13]
A new study indicates that adolescent females with acute leukemia have low rates of pregnancy screening prior to receiving chemotherapy that can cause birth defects.
For Teens With Leukemia, Pregnancy Tests Often Neglected
Source: MedicineNet Birth Defects Specialty [2016.09.12]
Title: For Teens With Leukemia, Pregnancy Tests Often Neglected
Category: Health News
Created: 9/12/2016 12:00:00 AM
Last Editorial Review: 9/12/2016 12:00:00 AM
Cord-Blood Transplants Show Promise in Leukemia Treatment
Source: MedicineNet Leukemia Specialty [2016.09.08]
Title: Cord-Blood Transplants Show Promise in Leukemia Treatment
Category: Health News
Created: 9/7/2016 12:00:00 AM
Last Editorial Review: 9/8/2016 12:00:00 AM
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...
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.
Page last updated: 2016-09-22