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Basic Drug Info
Drug Name:CYTARABINE
Manufacturer:Mayne Pharma (USA) Inc.
Other Info:

Procedures for proper handling and disposal of anti-cancer drugs should be considered.

Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.



Clinical Trials:


Indications and Usage

Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients.

It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.

Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
Leukemia, Myelocytic, Acute -- acute leukemia arising from myeloid tissue in which the granular, polymorphonuclear leukocytes and their precursors predominate.

Acute lymphocytic leukemia -- acute leukemia in which lymphoblasts and their progenitor cells predominate; the most common childhood cancer and accounts for 20 percent of adult acute leukemia; common ALL antigen (CALLA) expressed in most cases.

Precursor Cell Lymphoblastic Leukemia Lymphoma -- A neoplasm characterized by abnormalities of the lymphoid cell precursors leading to excessive lymphoblasts in the marrow and other organs. It is the most common cancer in children and accounts for the vast majority of all childhood leukemias.

Blast Phase -- An advanced phase of chronic myelogenous leukemia, characterized by a rapid increase in the proportion of immature white blood cells (blasts) in the blood and bone marrow to greater than 30%.

Myeloid Leukemia, Chronic -- chronic leukemia in which myeloid progenitor cells predominate; the hallmark of CML, the Philadelphia chromosome, is a reciprocal translocation between chromosomes 9 and 22 which activates the proto- oncogene c-abl.

Contraindications
Cytarabine Injection is contraindicated in those patients who are hypersensitive to the drug.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

(See boxed WARNING)Cytarabine is a potent bone marrow suppressant.

Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression.

Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily.

Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood.

Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia).

One case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported.

This occurred immediately after the intravenous administration of cytarabine injection.Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine injection) has been reported following some experimental dose schedules for cytarabine injection.

These reactions include reversible corneal toxicity, and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis.

Rarely, severe skin rash, leading to desquamation has been reported.

Complete alopecia is more commonly seen with experimental high dose therapy than with standard treatment programs using cytarabine injection.

If experimental high dose therapy is used, do not use a preparation containing benzyl alcohol.Cases of cardiomyopathy with subsequent death have been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation.A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients.

The outcome of this syndrome can be fatal.Two patients with childhood acute myelogenous leukemia who received intrathecal and intravenous cytarabine injection at conventional doses (in addition to a number of other concomitantly administered drugs) developed delayed progressive ascending paralysis resulting in death in one of the two patients.
Branded Drugs
The following US Branded drugs contain CYTARABINE


DEPOCYT -- PACIRA PHARMACEUTICALS INC

CYTOSAR-U -- TEVA PARENTERAL MEDICINES INC


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