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LEUSTAT SUBCUTANEOUS is a brand name for Cladribine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEUSTAT Subcutaneous Injection is indicated for the primary or secondary treatment of patients with Hairy Cell Leukaemia (HCL). LEUSTAT Subcutaneous 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…
Verbatim from this product's MHRA label. Tap a section to expand.
Therapy with Leustat Subcutaneous should be initiated by a qualified physician with experience in cancer chemotherapy. 14 mg/kg body weight for 5 consecutive days. 1 mg/kg body weight for 5 consecutive days. Deviations from the posology indicated above are not advised.
Elderly Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. 4). Renal and hepatic impairment There are no data on the use of Leustat Subcutaneous in patients with renal or hepatic impairment.
2). 3). Method of administration Leustat Subcutaneous is supplied as a ready-to-use solution for injection. The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution. Leustat Subcutaneous should be inspected visually for particulate matter and discoloration prior to administration.
Leustat Subcutaneous should warm up to room temperature prior to administration. Self-administration by the patient Leustat Subcutaneous can be self-administered by the patient. Patients should be instructed and trained appropriately.
Detailed instructions are contained in the Package Leaflet.
). Due to the prolonged immunosuppression associated with the use of nucleoside analogues like LEUSTAT Subcutaneous, 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 Subcutaneous 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 Subcutaneous is recommended. 8, Undesirable Effects).
CLL:
During the first 2 cycles of therapy with LEUSTAT Subcutaneous 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 Subcutaneous Injection. 3 Neurotoxicity: Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTAT Subcutaneous 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
Subcutaneous 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 Subcutaneous 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 Subcutaneous 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.
1. Pregnancy and lactation. Patients less than 18 years of age. 4). Concomitant use of other myelosuppressive medicinal products.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8°C) was associated with the use of LEUSTAT Subcutaneous 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 Subcutaneous 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 Subcutaneous, 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 Subcutaneous.
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 Subcutaneous, 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 Subcutaneous, 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 Subcutaneous, 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 Subcutaneous 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 Subcutaneous is recommended. 8, Undesirable Effects).
CLL:
During the first 2 cycles of therapy with LEUSTAT Subcutaneous 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 Subcutaneous Injection. 3 Neurotoxicity: Serious neurological toxicity (including irreversible paraparesis and quadraparesis) has been reported in patients who received LEUSTAT Subcutaneous 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 Subcutaneous 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 Subcutaneous Injection, and in less than 3% of patients during subsequent cycles. Forty of […]