LITAK 10
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Package(a):
VIALS (for I.V./S.C. injection): 1.
Dosage(a):
HCL: Subcutaneous bolus injection: 0.14 mg/kg body weight/day (5.6 mg/m²/day) for 5 consecutive days.
I.V. (Continuous infusion): Single course for 7 consecutive days: 0.09 mg/kg/day (3.6 mg/m²/day).
CLL: S.C.: 0.1 mg/kg body weight on 5 consecutive days (4.0 mg/m²/day) at monthly intervals.
I.V.: 2 hours on days, 1-5 of a 28 day cycle at a dose of 0.10 mg/kg/day (4.0 mg/m²/day). Determine patient response every 2 cycles of treatment, up to a maximum of 6 cycles in responding patients. In non-responding patients discontinue after 2 cycles.
Prescribing Restrictions:
Package(b):
VIALS (for I.V./S.C. injection): 5.
Dosage(b):
HCL: Subcutaneous bolus injection: 0.14 mg/kg body weight/day (5.6 mg/m²/day) for 5 consecutive days.
I.V. (Continuous infusion): Single course for 7 consecutive days: 0.09 mg/kg/day (3.6 mg/m²/day).
CLL: S.C.: 0.1 mg/kg body weight on 5 consecutive days (4.0 mg/m²/day) at monthly intervals.
I.V.: 2 hours on days, 1-5 of a 28 day cycle at a dose of 0.10 mg/kg/day (4.0 mg/m²/day). Determine patient response every 2 cycles of treatment, up to a maximum of 6 cycles in responding patients. In non-responding patients discontinue after 2 cycles.
Prescribing Restrictions:
Indications:
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL), second line treatment low grade, Non-Hodgkins lymphoma (NHL).
Contra-Indications:
Hypersensitivity, pregnancy, lactation.
Special Precautions:
Children safety and efficacy in children have not been established. Must be diluted with the designated diluent prior to administration and should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Patients should be monitored closely for infections. Careful hematological monitoring, especially during the first 4-8 weeks after treatment is recommended. Patients should be closely monitored during the first month of treatment and empirical antibiotics should be initiated. Caution is advised when administering the drug to patients with known or suspected renal or hepatic insufficiency.
Side Effects:
Suppression of bone marrow function. Serious neurological toxicity (including irreversible paraparesis and quadraparesis) in patients who received Litak 10 by continuous infusion at high doses (4 to 9 times the recommended dose), reported rarely with the recommended dose. Neutropenia, infection, fatigue, nausea, rash, headache, decreased appetite.
Drug Interactions:
N/A.
