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LEUSTAT is a brand name for Cladribine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEUSTAT™ injection is indicated for the primary or secondary treatment of patients with Hairy Cell Leukaemia (HCL). LEUSTAT is also indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) who have not responded to, or whose disease has progressed during or after, treatment with at least…
Verbatim from this product's MHRA label. Tap a section to expand.
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. 8 mg/m2/day). The patient’s response to therapy should be determined every two cycles of treatment.
It is recommended that LEUSTAT Injection be 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.
e. 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 LEUSTAT™ 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 haematologic and renal and hepatic toxicity.
Preparation and Administration of Intravenous Solutions:
LEUSTAT™ Injection 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 LEUSTAT™.
6 Instructions for Use/Handling.
). Due to the prolonged immunosuppression associated with the use of nucleoside analogues like LEUSTAT, secondary malignancies are a potential risk. Primary haematological malignancies are also a risk factor for secondary malignancies.
HCL:
During the first two weeks after treatment initiation, mean platelet count, absolute neutrophil count (ANC), and haemoglobin concentration declined and then subsequently increased with normalisation of mean counts by day 15, week 5 and week 8, respectively.
The myelosuppressive effects of LEUSTAT were most notable during the first month following treatment. Forty three percent (43%) of patients received transfusions with RBCs and 13% received transfusions with platelets during month 1.
Careful haematological monitoring, especially during the first 4 to 8 weeks after treatment with LEUSTAT is recommended. 8, Undesirable Effects).
CLL:
During the first 2 cycles of therapy with LEUSTAT Injection, haemoglobin concentration, platelet count and absolute neutrophil count declined to a nadir usually observed in Cycle 2. There appeared to be no cumulative toxicity upon administration of further cycles of therapy.
Careful haematological monitoring is recommended throughout administration of LEUSTAT Injection. 3 Neurotoxicity: Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTAT Injection by continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukaemia).
Neurological toxicity appears to demonstrate a dose relationship; however, severe neurological toxicities have been reported rarely with the recommended dose. Physicians should consider delaying or discontinuing therapy if neurotoxicity occurs.
LEUSTAT
Injection is a potent antineoplastic agent with potentially significant toxic side effects. It should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
CLL:
The weight of evidence suggests that a patient whose disease has progressed while treated with fludaribine is unlikely to respond to treatment with LEUSTAT Injection and therefore use in such a patient is not recommended. 8: Undesirable Effects).
Patients with active infection should be treated for the underlying condition prior to receiving therapy with LEUSTAT Injection. Patients who are or who become Coombs’ positive should be monitored carefully for potential haemolysis.
Patients should be monitored closely for infections. Those presenting with herpes infections should be treated with acyclovir. 91% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This should be taken into consideration in patients with a sodium free regimen.
Elderly patients should be treated by individual assessment, and careful monitoring of blood counts and renal and hepatic function. The risk requires assessment on a case- by-case basis. Patients with high tumour burden or who are considered at risk for the development of hyperuricaemia as a result of tumour breakdown should receive appropriate prophylactic treatment.
Allopurinol and adequate hydration should be considered for patients with initially high WBC, to alleviate potential tumour lysis syndrome side effects of therapy. 1 Progressive multifocal leukoencephalopathy (PML) Cases of PML, including fatal cases, have been reported with cladribine.
PML was reported 6 months to several years after treatment with cladribine. An association with prolonged lymphopenia has been reported in several of these cases. Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
LEUSTAT
Injection is contra-indicated in patients hypersensitive to cladribine or other components of this product. Pregnancy and lactation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cladribine in United Kingdom.
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8°C) was associated with the use of LEUSTAT in approximately 72% (89/124) of patients. Most febrile episodes occurred during the first month. Although seventy percent (70%) of patients were treated empirically with parenteral antibiotics, less than a third of febrile events were associated with documented infection.
CLL:
Pyrexia was reported in 22-24% of CLL patients during Cycle 1 of therapy with LEUSTAT Injection, and in less than 3% of patients during subsequent cycles. 5%) reported at least one infection during Cycle 1. 7%). Approximately 70% of patients had at least one infection during the overall study period of 6 years, including treatment and follow-up.
Since the majority of fevers occurred in neutropenic patients, patients should be closely monitored during the first month of treatment and empirical antibiotics should be initiated as clinically indicated. Given the known myelosuppressive effects of LEUSTAT, practitioners should carefully evaluate the risks and benefits of administering this drug to patients with active infections.
8, Undesirable effects). 5 Rare cases of tumour lysis syndrome have been reported in patients with haematological malignancies having a high tumour burden. 6 Effect on Renal and Hepatic Function: Acute renal insufficiency has developed in some patients receiving high doses of LEUSTAT.
In addition, there are inadequate data on dosing of patients with renal or hepatic insufficiency. Until more information is available, caution is advised when administering the drug to patients with known or suspected renal or hepatic insufficiency.
As with other potent chemotherapeutic agents, monitoring of renal and hepatic function should be performed as clinically indicated, especially in patients with underlying kidney or liver dysfunction. Physicians should consider delaying or discontinuing therapy if renal toxicity occurs.
8 Undesirable Effects and
Suggested evaluation for PML includes neurology consultation, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
A negative JCV PCR does not exclude PML. Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established. Patients with suspected PML should not receive further treatment with cladribine. 2 Bone Marrow Suppression: Suppression of bone marrow function should be anticipated.
This is usually reversible and appears to be dose dependent. Severe bone marrow suppression, including neutropenia, anaemia and thrombocytopenia, has been commonly observed in patients treated with LEUSTAT, especially at high doses.
At initiation of treatment, most patients in the clinical studies had haematological impairment as a manifestation of active Hairy Cell Leukaemia or Chronic Lymphocytic Leukaemia. Following treatment with LEUSTAT, further haematological impairment occurred before recovery of peripheral blood counts began.
8 Undesirable Effects). Due to the prolonged immunosuppression associated with the use of nucleoside analogues like LEUSTAT, secondary malignancies are a potential risk. Primary haematological malignancies are also a risk factor for secondary malignancies.
HCL:
During the first two weeks after treatment initiation, mean platelet count, absolute neutrophil count (ANC), and haemoglobin concentration declined and then subsequently increased with normalisation of mean counts by day 15, week 5 and week 8, respectively.
The myelosuppressive effects of LEUSTAT were most notable during the first month following treatment. Forty three percent (43%) of patients received transfusions with RBCs and 13% received transfusions with platelets during month 1.
Careful haematological monitoring, especially during the first 4 to 8 weeks after treatment with LEUSTAT is recommended. 8, Undesirable Effects).
CLL:
During the first 2 cycles of therapy with LEUSTAT Injection, haemoglobin concentration, platelet count and absolute neutrophil count declined to a nadir usually observed in Cycle 2. There appeared to be no cumulative toxicity upon administration of further cycles of therapy.
Careful haematological monitoring is recommended throughout administration of LEUSTAT Injection. 3 Neurotoxicity: Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTAT Injection by continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukaemia).
Neurological toxicity appears to demonstrate a dose relationship; however, severe neurological toxicities have been reported rarely with the recommended dose. Physicians should consider delaying or discontinuing therapy if neurotoxicity occurs.
8°C) was associated with the use of LEUSTAT in approximately 72% (89/124) of patients. Most febrile episodes occurred during the first month. Although seventy percent (70%) of patients were treated empirically with parenteral antibiotics, less than a third of febrile events were associated with documented infection.
CLL:
Pyrexia was reported in 22-24% of CLL patients during Cycle 1 of therapy with LEUSTAT Injection, and in less than 3% of patients during subsequent cycles. 5%) reported at least one infection during Cycle 1. 9%), pneumonia […]