Lumoxiti

Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. 04 mg/kg administered as a 30-minute intravenous infusion on Days 1, 3, and 5 of each 28-day cycle. Patients should continue treatment for a maximum of 6 cycles, or until disease progression or unacceptable toxicity.

Treatment may be stopped at the physician’s discretion if complete response (CR) without minimal residual disease (MRD) is achieved prior to the completion of 6 cycles. g. 45%] solution for injection) should be administered intravenously over 2-4 hours before and after each Lumoxiti infusion.

Medicinal product no longer authorised 3 Patients should be adequately hydrated. Patients are advised to drink 3 L of oral fluids per 24 hours on Days 1 through 8 of each 28-day cycle. In patients under 50 kg, 2 L per day is recommended.

4). g. g. g. ranitidine, famotidine, or cimetidine). 4 for further instructions. Dose adjustments Lumoxiti treatment must be withheld and/or discontinued to manage adverse reactions as described below. Haemolytic uraemic syndrome (HUS) and capillary leak syndrome (CLS) are identified based on clinical presentation (see Table 1).

5- to 3-times baseline or the upper limit of normal) If HUS is suspected based on the above, promptly check blood LDH, indirect bilirubin and blood smear schistocytes for evidence of haemolysis.  If weight has increased by ≥10% from Day 1 of the cycle and the patient is hypotensive, promptly check for peripheral oedema, hypoalbuminaemia, and respiratory symptoms, including shortness of breath and cough.

 If CLS is suspected, check for a decrease in oxygen saturation and evidence of pulmonary oedema and/or serosal effusions. Medicinal product no longer authorised 4 Table 2 HUS grading and management guidance HUS grade Lumoxiti dosing Grade 2 Evidence of RBC destruction (schistocytosis) and mild renal insufficiency without clinical consequences Delay dosing until recovery of haemolysis and serum creatinine to Grade 1 or baseline.

Discontinue Lumoxiti upon recurrence. g. haemolysis with progressive renal failure, petechiae) Discontinue Lumoxiti. g. 03. 4). Table 3 CLS grading and management guidance CLS grade Lumoxiti dosing Grade 2 Symptomatic; intervention indicated Delay dosing until recovery of symptoms.

Summary of the safety profile The overall safety profile of Lumoxiti is based on data from 80 patients from Study 1053 (a Phase 3 study). 3%). 3%). 0% of patients. 0%). 5%). Tabulated list of adverse reactions ADRs are listed according to system organ class (SOC) in MedDRA.

Within each SOC, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Frequency category for each ADR is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from available data).

3%. The median time to first onset of HUS was 33 days (range: 9-92), and may occur during any cycle of treatment with Lumoxiti. Most cases of HUS occurred in the first 9 days (range: 1-16) of a treatment cycle. 5 days (range: 2-44). All cases resolved, including those who discontinued Lumoxiti.

The median end of treatment creatinine clearance (as estimated by Cockcroft-Gault) was higher among patients without HUS (89 mL/min, range 42-195) compared with patients with HUS (76 mL/min, range 19-96). 4. 8% of patients, the majority were Grade 2.

5% Grade 4 events. The median time to onset of CLS was 37 days (range: 5-92), and may occur during any cycle of treatment. Most cases of CLS occurred in the first 9 days (range: 1-24) of a treatment cycle. All CLS resolved, with a median time to resolution of 36 days (range: 10-53).

4. 3% of patients. 5%) of patients. Serum creatinine levels remained elevated above Grade 2 in 5% of patients, two of these patients had Grade 3 or 4 HUS. 5% of patients. 2). Special populations Elderly In Study 1053, 39% of patients treated with Lumoxiti were 65 years of age or older.

Patients ≥65 years of age had lower median creatinine clearance at baseline and at the end of treatment compared with patients <65 years of age (78 and 69 mL/min versus 114 and 98 mL/min, respectively). Immunogenicity In Study 1053, 88% (70/80) of patients were positive for ADA (before or after treatment).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Lumoxiti should be avoided in patients with prior history of severe thrombotic microangiopathy (TMA) or HUS.

2). In Study 1053, patients with a platelet count ≥100,000/mm3 received low-dose acetylsalicylic acid on Days 1 through 8 of each 28-day cycle for prophylaxis of renal insufficiency. Blood chemistry and complete blood counts should be monitored prior to each dose and as clinically indicated during treatment.

Monitoring mid-cycle is also recommended. 2). The events of HUS may be life-threatening if treatment is delayed with increased risk of progressive renal failure requiring dialysis. If HUS is suspected appropriate supportive measures including fluid repletion and haemodynamic monitoring should be initiated, and hospitalisation as clinically indicated should be considered.

2). 8). Patient weight and blood pressure should be monitored prior to each Lumoxiti infusion and as clinically indicated during treatment. Patients should be assessed for signs and symptoms of CLS including weight gain (≥10% from Day 1 of current cycle), hypotension, peripheral oedema, shortness of breath or cough, and pulmonary oedema and/or serosal effusions.

2). CLS may be life-threatening or fatal if treatment is delayed. Patients should be advised to seek immediate medical attention should signs or symptoms of CLS occur at any time. Patients who develop CLS should receive appropriate supportive measures, including concomitant oral or intravenous corticosteroids, and hospitalisation as clinically indicated.

2). 8). Treatment with Lumoxiti is not recommended in patients with pre-existing severe renal impairment (creatinine clearance ≤29 mL/min). Renal function should be monitored prior to each infusion of Lumoxiti, and as clinically indicated throughout treatment.

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