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CERUBIDINE

Package:
AMPOULES: Outfit: 1 ampoule in dry state 3 + 4 ml water for injection.
Dosage:
May only be administered I.V. Should be further diluted with normal saline to give a final concentration of 1 mg/ml. This solution should be injected over a 20 minute period into the tubing, or a side arm.
Adults: 40-60 mg/m² on alternate days for a course of up to three injections for the induction of remissions. 
Acute myelogenous leukemia: 45 mg/m²/day.
Acute lymphocytic leukemia: 45 mg/m²/day.
Children: Over 2 years: as adults. Under 2 years or if less than 0.5 m² surface area: 1 mg/kg/day.
Prescribing Restrictions:  


Indications:
Acute leukemia, chronic myeloid leukemia, Hodgkin’s disease, neoplasm.
Contra-Indications:
Patients recently exposed to, or with existing chicken pox or herpes zoster. Do not administer I.M. or S.C.
Special Precautions:
Should be used under the direction of a clinician conversant with the management of acute leukemia and cytoxic chemotherapy. The hematological status of patients should be monitored regularly. Each patient should be given a clinicial and bacteriological examination to determine whether infection is present; any infections should be adequately eliminated before the treatment, which might depress the bone marrow. Anti-infective therapy should be employed in the presence of suspected or confirmed infection and during a phase of aplasia. It should be continued for some time after the marrow has regenerated. May cause a rise in blood uric or urea and so it is a wise precaution to check these concentrations three or four times a week during the first week of treatment. Patients with heart disease should not be treated with this potentially cardiotoxic drug. In patients at risk of hyperuricemia. Care should be taken to avoid extravasation during intravenous administration. 
Pregnancy and lactation: Treatment during pregnancy may produce delayed effects in the offspring. If appropriate the mother should be offered the opportunity of a therapeutic abortion. Breast feeding should be discontinued during treatment. See prescribing information for full details.
Side Effects:
Bone marrow depression, severe aplasia, leucopenia, stomatitis, alopecia, phlebitis, fever, anemia, nausea, vomiting, mucositis, diarrhea and rash, temporarily red-colored urine. See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.