ALEXAN
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Package(a):
VIALS (ready for use): 1 x 100 mg (5 ml).
Dosage(a):
Induction of remission of acute myelocytic leukemia in adults, maintenance of acute myelocytic leukemia, acute lymphocytic leukemia: 200 mg/m²/day by continuous infusion for 5 days (120 hours) for a total dose of 1,000 mg/m². This course is repeated approximately every 2 weeks. Combined chemotherapy: In cases of persistent leukemia, administer additional courses (complete or modified) of any combination, as necessary, at 2-4 week intervals. See data sheet for dosage chart. Refractory acute leukemia: A high-dose cytarabine 3 mg/m² I.V. every 12 hours for 4-12 doses (repeated at 2-3 week intervals). Therapies using 4-6 doses every 2 weeks or 9 doses every 3 weeks appear equally effective and less toxic. Meningeal leukemia (intrathecally): Doses range from 5 mg/m² to 75 mg/m² once daily for 4 days or once every 4 days.
Prescribing Restrictions:
Package(b):
VIALS (ready for use): 1 x 500 mg (10 ml).
Dosage(b):
Induction of remission of acute myelocytic leukemia in adults, maintenance of acute myelocytic leukemia, acute lymphocytic leukemia: 200 mg/m²/day by continuous infusion for 5 days (120 hours) for a total dose of 1,000 mg/m². This course is repeated approximately every 2 weeks. Combined chemotherapy: In cases of persistent leukemia, administer additional courses (complete or modified) of any combination, as necessary, at 2-4 week intervals. See data sheet for dosage chart. Refractory acute leukemia: A high-dose cytarabine 3 mg/m² I.V. every 12 hours for 4-12 doses (repeated at 2-3 week intervals). Therapies using 4-6 doses every 2 weeks or 9 doses every 3 weeks appear equally effective and less toxic. Meningeal leukemia (intrathecally): Doses range from 5 mg/m² to 75 mg/m² once daily for 4 days or once every 4 days.
Prescribing Restrictions:
Package(c):
VIALS (ready for use): 1 x 1,000 mg (20 ml).
Dosage(c):
Induction of remission of acute myelocytic leukemia in adults, maintenance of acute myelocytic leukemia, acute lymphocytic leukemia: 200 mg/m²/day by continuous infusion for 5 days (120 hours) for a total dose of 1,000 mg/m². This course is repeated approximately every 2 weeks. Combined chemotherapy: In cases of persistent leukemia, administer additional courses (complete or modified) of any combination, as necessary, at 2-4 week intervals. See data sheet for dosage chart. Refractory acute leukemia: A high-dose cytarabine 3 mg/m² I.V. every 12 hours for 4-12 doses (repeated at 2-3 week intervals). Therapies using 4-6 doses every 2 weeks or 9 doses every 3 weeks appear equally effective and less toxic. Meningeal leukemia (intrathecally): Doses range from 5 mg/m² to 75 mg/m² once daily for 4 days or once every 4 days.
Prescribing Restrictions: None
Package(d):
VIALS (ready for use): 1 x 2,000 mg (40 ml).
Dosage(d):
Induction of remission of acute myelocytic leukemia in adults, maintenance of acute myelocytic leukemia, acute lymphocytic leukemia: 200 mg/m²/day by continuous infusion for 5 days (120 hours) for a total dose of 1,000 mg/m². This course is repeated approximately every 2 weeks. Combined chemotherapy: In cases of persistent leukemia, administer additional courses (complete or modified) of any combination, as necessary, at 2-4 week intervals. See data sheet for dosage chart. Refractory acute leukemia: A high-dose cytarabine 3 mg/m² I.V. every 12 hours for 4-12 doses (repeated at 2-3 week intervals). Therapies using 4-6 doses every 2 weeks or 9 doses every 3 weeks appear equally effective and less toxic. Meningeal leukemia (intrathecally): Doses range from 5 mg/m² to 75 mg/m² once daily for 4 days or once every 4 days.
Prescribing Restrictions: None
Indications:
For reduction and maintenance of clinical remission in patients with acute myeloid leukemia, acute non-lymphoblastic leukemias, acute lymphoblastic leukemias, blast crises of chronic myeloid leukemia, diffuse histiocytic lymphomas (non-Hodgkin's lymphomas of high malignancy).
Contra-Indications:
Known hypersensitivity to drug, bone marrow suppression. Leukopenia and/or thrombocytopenia of non-malignant origin. High-dose therapy with cytarabine in patients older than 60 years should only be carried out after carefully weighing the benefits and risks. Pregnancy, lactation.
Special Precautions:
Pre-existing drug-induced bone marrow suppression. Leukocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. Contraceptive measures, monitor closely. Hepatic dysfunction. Acute pancreatitis. Patients on high-dose: neuropathy.
Side Effects:
Anemia, leukopenia, thrombocytopenia, megaloblastosis, reduced reticulocytes. High dose therapy: myelotoxicity. Infectious complications. GI disturbances. Toxic skin reactions in the form of maculopapular exanthemas, erythrodermias or erythemas can be observed. Alopecia may occur. Myalgias and/or arthralgias in the region of the neck and the legs after high doses, conjunctivitis, keratitis, photophobia, burning eyes, strong lacrimation, impaired vision, liver damage, increased plasma creatinine.
Drug Interactions:
See prescribing information for full details.
