Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
For induction therapy 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. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration and hepatic dysfunction.
The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgment or beginning treatment, the physician should be familiar with the following text.
NOT FOR INTRATHECAL USE -
CONTAINS BENZYL ALCOHOL
FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY
Cytarabine Injection, an antineoplastic agent, is a sterile preserved solution for intravenous or subcutaneous administration, and is available in a 500 mg (20 mg/mL) multidose vial.
Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. 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 only) is indicated for the prophylaxis and treatment of meningeal leukemia.
Published Studies Related to Cytarabine
Comparison of high-dose cytarabine and timed-sequential chemotherapy as consolidation for younger adults with AML in first remission: the ALFA-9802 study. [2011.08.18]
To assess the value of administering timed-sequential chemotherapy (TSC; 2 therapeutic sequences separated by a 4-day interval-free chemotherapy) or high-dose cytarabine (HDAraC) cycles in consolidation therapy for acute myeloid leukemia (AML), 459 patients 15 to 50 years of age were enrolled in the prospective randomized Acute Leukemia French Association-9802 trial...
Cytarabine dose of 36 g/m(2) compared with 12 g/m(2) within first consolidation in acute myeloid leukemia: results of patients enrolled onto the prospective randomized AML96 study. [2011.07.01]
PURPOSE: To assess the optimal cumulative dose of cytarabine for treatment of young adults with acute myeloid leukemia (AML) within a prospective multicenter treatment trial... CONCLUSION: In young adults with AML receiving intermediate-dose cytarabine induction, intensification of the cytarabine dose beyond 12 g/m(2) within first consolidation did not improve treatment outcome.
Cytarabine dose for acute myeloid leukemia. [2011.03.17]
BACKGROUND: Cytarabine (ara-C) is an important drug in the treatment of acute myeloid leukemia (AML). High-dose cytarabine (2000 to 3000 mg per square meter of body-surface area) is toxic but results in higher rates of relapse-free survival than does the conventional dose of 100 to 400 mg per square meter. Intermediate dose levels have not been thoroughly evaluated... CONCLUSIONS: Induction therapy with cytarabine at the lower dose already produced maximal antileukemic effects for all response end points, suggesting a plateau in the dose-response relationship above this dose level. High-dose cytarabine results in excessive toxic effects without therapeutic benefit. (Netherlands Trial Register number, NTR230.).
A randomized comparison of 4 courses of standard-dose multiagent chemotherapy versus 3 courses of high-dose cytarabine alone in postremission therapy for acute myeloid leukemia in adults: the JALSG AML201 Study. [2011.02.24]
We conducted a prospective randomized study to assess the optimal postremission therapy for adult acute myeloid leukemia in patients younger than 65 years in the first complete remission. A total of 781 patients in complete remission were randomly assigned to receive consolidation chemotherapy of either 3 courses of high-dose cytarabine (HiDAC, 2 g/m(2) twice daily for 5 days) alone or 4 courses of conventional standard-dose multiagent chemotherapy (CT) established in the previous JALSG AML97 study...
Randomized trial of response-oriented individualized versus fixed-schedule induction chemotherapy with idarubicin and cytarabine in adult acute myeloid leukemia: the JALSG AML95 study. [2010.03]
A multicenter, prospective, randomized study was conducted to compare a response-oriented individualized remission induction therapy with a standard fixed-schedule induction therapy, using idarubicin (IDR) and cytarabine (Ara-C), in adult patients with acute myeloid leukemia (AML)...
Clinical Trials Related to Cytarabine
2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) [Active, not recruiting]
1. To determine the response rate, progression-free survival (PFS) and overall survival of
patients who receive 2-CdA + Ara-C.
2. To examine if there is any clonality in the cytokine expression of helper T cells or
cytokine receptor expression of eosinophils.
3. To determine the effect of 2-CdA on accumulation of Ara-C triphosphate in eosinophils.
Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyteŽ) Versus Intrathecal Liposomal Cytarabine (DepoCyteŽ) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis. [Not yet recruiting]
The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy
(WBRT) together with intrathecal liposomal cytarabine (DepoCyteŽ) for patients with
leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same
time as WBRT with giving the drug after WBRT is complete.
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment [Recruiting]
The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase
I part of the trial, two schedules of BI 811283 in combination with LD-Ara-C will be
investigated. In the phase I part, the dose of BI 811283 will be escalated to determine the
maximum tolerated dose (MTD) of the two dosing schedules of BI 811283 in combination with
In the phase IIa part, the two combination schedules of BI 811283 at MTD with LD-Ara-C and
one LD-Ara-C monotherapy schedule will be investigated to determine the efficacy of the two
combination schedules in comparison to LD-Ara-C monotherapy in previously untreated AML
patients ineligible for intensive treatment.
A Phase 1 Dose-escalation Study of a Cell Cycle Inhibitor With and Without Cytarabine in Patients With Acute Leukemias (Study P05247) [Recruiting]
This study of SCH 900776 will evaluate its safety and tolerability when given in combination
with cytarabine to patients with acute leukemias. Subjects in the Dose-Escalation Part will
be enrolled in cohorts that will receive sequentially higher doses of SCH 900776 in
combination with standard doses of cytarabine. Only one combination treatment cycle of
approximately 4 to 6 weeks is anticipated, but subjects may receive additional cycles if
clinically indicated after discussion between the investigator and the sponsor. The
recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety
and biological activity. Up to 10 to 15 additional subjects will be studied at the
A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia [Recruiting]
This is an open label randomized controlled phase II study of AS1411 combined with
Cytarabine in the treatment of patients with primary refractory or relapsed acute myeloid
Reports of Suspected Cytarabine Side Effects
Febrile Neutropenia (153),
Respiratory Failure (96),
Blood Bilirubin Increased (83), more >>