Presentation and Status in Health Basket
1 X 10 mg / 5 ml
Subcutaneous: The recommended treatment for hairy cell leukaemia is a single course of LITAK 10 given by subcutaneous bolus injection at a dose of 0.14 mg/kg BW/day (5.6 mg/m²/day) for 5 consecutive days.
Intravenous: The recommended treatment for hairy cell leukaemia is a single course of LITAK 10 given by continuous intravenous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day (3.6 mg/m²/day).
Deviations from this dosage regimen are not advised. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs.
CLL and NHL:
Subcutaneous: The recommended dose is 0.1 mg/kg BW/day on 5 consecutive days (4.0 mg/m²/day) given at monthly intervals.
Experience with treatment for more than 3 cycles is limited.
Intravenous: In patients with CLL, the recommended treatment consists of a continuous intravenous infusion of LITAK 10 for 2 hours on days 1 to 5 of a 28 day cycle at a dose of 0.10 mg/kg/day (4.0 mg/m²/day). The patient’s response to therapy should be determined every two cycles of treatment. It is recommended that LITAK 10 is administered in responding patients for 2 cycles after maximum response has occurred, up to a maximum of 6 cycles. Therapy should be discontinued after 2 cycles in non-responding patients. Response for this treatment decision is defined as a lymphocyte reduction of 50% or more, ie if lymphocyte count decreases by 50% or more, administer 2 more cycles and re-evaluate response for decision whether to continue with 2 more cycles up to a maximum of 6 cycles.
Children: Safety and efficacy in children have not been established. Specific risk factors predisposing to increased toxicity from LITAK 10 have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any aetiology. Patients should be monitored closely for haematological as well as renal and hepatic toxicity.
Preparation and administration of intravenous solutions: LITAK 10 must be diluted with the designated diluent prior to administration.
Since the drug product does not contain any anti-microbial preservative or bacteriostatic agent, aseptic technique and proper environmental precautions must be observed in preparation of a solution of LITAK 10.
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL), second line treatment low grade, Non-Hodgkins lymphoma (NHL).
Hypersensitivity, pregnancy, lactation.
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.
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.
Caution should be exercised if LITAK 10 is administered following or in conjunction with other drugs known to cause myelosuppression. Following administration of LITAK 10, caution should be exercised before administering other immunosuppressive or myelosuppressive therapy.
Pregnancy and Lactation
LITAK 10 is teratogenic in mice and rabbits and consequently has the potential to cause foetal harm when administered to a pregnant woman. There are no human data, but LITAK 10 is contra-indicated in pregnancy.
See prescribing information for full details.
High doses of cladribine have been associated with serious neurological toxicity (including irreversible paraparesis/quadraparesis), acute nephrotoxicity, and severe bone marrow suppression resulting in neutropenia, anaemia and thrombocytopenia. (See Special warnings and special precautions for use). There is no known specific antidote to overdosage.
It is not known whether the drug can be removed from the circulation by dialysis or haemofiltration. Treatment of overdosage consists of discontinuation of LITAK 10, careful observation and appropriate supportive measures.