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Evoltra is a brand name for Clofarabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old…
Verbatim from this product's EMA label. Tap a section to expand.
Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias. 2). Paediatric population Children and adolescents (≥ 1 year old) The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle. e. 75 × 109/l) and return to baseline organ function. A 25% dose reduction 3 may be warranted in patients experiencing significant toxicities (see below).
4). 1). 4). 2). Children < 1 year old There are no data on the pharmacokinetics, safety or efficacy of clofarabine in infants. Therefore, a safe and effective dosage recommendation for patients < 1 year old has yet to be established. Dose reduction for patients experiencing haematological toxicities If the ANC does not recover by 6 weeks from the start of a treatment cycle, a bone marrow aspirate / biopsy should be performed to determine possible refractory disease.
75 × 109/l. 5 × 109/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%. Dose reduction for patients experiencing non-haematological toxicities Infectious events If a patient develops a clinically significant infection, clofarabine treatment may be withheld until the infection is clinically controlled.
At this time, treatment may be reinitiated at the full dose. In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Non-infectious events If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
It is then recommended that clofarabine be administered at a 25% dose reduction. Should a patient experience the same severe toxicity on a second occasion, treatment should be delayed until the toxicity resolves to baseline parameters or to the point where it is no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Summary of the safety profile Nearly all patients (98%) experienced at least one adverse event considered by the study investigator to be related to clofarabine. Those most frequently reported were nausea (61% of patients), vomiting (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%).
Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event. One patient discontinued treatment due to grade 4 hyperbilirubinaemia considered as related to clofarabine after receiving 52 mg/m2/day clofarabine.
Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure.
Tabulated list of adverse reactions The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m2 daily x
8). The following parameters should be closely monitored in patients undergoing treatment with clofarabine: • Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias.
• Renal and hepatic function prior to, during active treatment and following therapy. Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed. • Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
Blood and lymphatic disorders Suppression of bone marrow should be anticipated. This is usually reversible and appears to be dose- dependent. Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
Haemorrhage, including cerebral, gastrointestinal and pulmonary haemorrhage, has been reported and may be fatal. 8). In addition, at initiation of treatment, most patients in the clinical studies had haematological impairment as a manifestation of leukaemia.
Because of the pre-existing immuno-compromised condition of these patients and prolonged neutropaenia that can result from treatment with clofarabine, patients are at increased risk for severe opportunistic infections, including severe sepsis, with potentially fatal outcomes.
Patients should be monitored for signs and symptoms of infection and treated promptly. Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis, have been reported during treatment with clofarabine.
This has occurred more frequently within 30 days of treatment, and in the setting of combination chemotherapy. 8). Patients should be monitored for signs and symptoms of enterocolitis. 8). Clofarabine must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected.
1. Use in patients with severe renal insufficiency or severe hepatic impairment. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It is then recommended that clofarabine be administered at a further 25% dose reduction. 4). 2). 4). 2). 5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity. 4). Method of administration The recommended dosage should be administered by intravenous infusion although it has been administered via a central venous catheter in clinical trials.
2). 6).
Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells. g. 8). • Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis) is expected.
• Patients should receive intravenous fluids throughout the 5 day clofarabine administration period to reduce the effects of tumour lysis and other events. , 100 mg/m2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak.
Clofarabine should be discontinued immediately if patients show early signs or symptoms of SIRS, capillary leak syndrome or substantial organ dysfunction and appropriate supportive measures instituted. In addition, clofarabine treatment should be discontinued if the patient develops hypotension for any reason during the 5 days of administration.
Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline. 1). Therefore, the potential benefit and risks associated with continued therapy in patients who do not show haematological and/or clinical improvement after 2 treatment cycles should be assessed by the treating physician.
8). Renal and urinary disorders There is no clinical study experience in paediatric patients with renal insufficiency (defined in clinical studies as serum creatinine ≥ 2 x ULN for age) and clofarabine is predominately excreted via the kidneys.
2). 2 for dose adjustments). 3). 8). 8). Patients should be monitored for renal toxicity and clofarabine should be discontinued as necessary. It was observed that the frequency and severity of adverse reactions, in particular infection, […]