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FDA Alerts
Experience of Supervising Clinician
Conventional cytarabine: Use only under supervision of qualified clinicians experienced in therapy with antineoplastic agents. Consider possible benefits vs known risks of cytarabine treatment.
Liposomal cytarabine: Use only under supervision of qualified clinicians experienced in intrathecal therapy with antineoplastic agents; adequate diagnostic and treatment facilities must be readily available for management of complications.
Induction Therapy with Conventional Cytarabine
Patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.
Risk of serious adverse effects, including myelosuppression with leukopenia, thrombocytopenia, and anemia. Less serious adverse effects include nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction. (See Cautions.)
Chemical Arachnoiditis with Intrathecal Liposomal Cytarabine
Chemical arachnoiditis, a syndrome manifested principally by nausea, vomiting, headache, and fever, commonly occurs. If left untreated, may be fatal. (See Chemical Arachnoiditis Related to Liposomal Cytarabine under Cautions.)
Administer dexamethasone to ameliorate symptoms and reduce incidence. (See Liposomal Cytarabine under Dosage and Administration.)
Conventional cytarabine: Remission induction (in combination with other antineoplastic agents) in AML (acute nonlymphocytic leukemia) in children and adults.
Conventional cytarabine and either idarubicin or daunorubicin (with or without thioguanine) are currently preferred components of induction regimens. However, various regimens have been used in combination therapy, and comparative efficacy is continually being evaluated.
Conventional cytarabine: Has been used with other antineoplastic agents in regimens of consolidation following induction of a complete remission†; role of such therapy in prolonging remissions and optimal dosage, schedules, and duration of consolidation chemotherapy regimens not established.
Conventional cytarabine: Has been used with other antineoplastic agents in the treatment of erythroleukemia.
Conventional cytarabine: Also has been used alone in high-dose† regimens to induce remissions in some patients with refractory AML or with secondary AML.
Acute Lymphocytic Leukemia (ALL)
Conventional cytarabine: Has been used alone or with other antineoplastic agents for remission induction in ALL; however, combinations containing other antineoplastic agents are more effective.
Conventional cytarabine: Generally has been limited to use with other antineoplastics for remission induction in some patients who do not achieve a complete remission with combinations containing other agents or who relapse during maintenance therapy.
Conventional cytarabine: Also has been used occasionally in regimens of consolidation and/or maintenance therapy following induction of a complete remission by combinations containing other agents.
Conventional cytarabine: Has been used alone in high-dose† regimens to induce remissions in some patients with refractory ALL.
Meningeal Leukemia and Other Meningeal Neoplasms
Conventional cytarabine: Has been used effectively alone or with other chemotherapeutic agents in treatment, maintenance, and prophylactic therapy of meningeal leukemia and other meningeal neoplasms (e.g., lymphoma).
Many clinicians consider intrathecal conventional cytarabine and intrathecal methotrexate to have similar efficacy in the treatment of these conditions; however, intrathecal conventional cytarabine produces less systemic toxicity than intrathecal methotrexate.
Liposomal cytarabine: Treatment of lymphomatous meningitis.
Intrathecal liposomal cytarabine appears to have greater efficacy in the treatment of neoplastic meningitis and less systemic toxicity compared with intrathecal conventional cytarabine; however, further study is needed.
Chronic Myelogenous Leukemia (CML)
Conventional cytarabine: Used with other antineoplastic agents (e.g., daunorubicin) in the treatment of accelerated or blast phase of CML; however, various regimens have been used in combination therapy, and comparative efficacy is continually being evaluated.
Non-Hodgkin’s Lymphomas
Conventional cytarabine: Has been used with other antineoplastic agents for maintenance therapy of non-Hodgkin’s lymphoma in children†.†
Conventional cytarabine: Has been used with other antineoplastic agents for remission induction and/or maintenance therapy in adults with non-Hodgkin’s lymphomas, principally advanced diffuse histiocytic lymphoma†.†
Conventional cytarabine: Has been used alone in high-dose† regimens with some success for the treatment of refractory non-Hodgkin’s lymphomas†.†
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