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Besponsa is a brand name for Inotuzumab Ozogamicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase…
Verbatim from this product's EMA label. Tap a section to expand.
BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. 1). For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count ≤ 10,000/mm3 is recommended prior to the first dose.
4). 4). 4). Posology BESPONSA should be administered in 3- to 4-week cycles. For patients proceeding to HSCT, the recommended duration of treatment is 2 cycles. 4). For patients not proceeding to HSCT, a maximum of 6 cycles may be administered.
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment. Table 1 shows the recommended dosing regimens. 5 mg/m2). Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a CR or CRi, and/or to allow recovery from toxicity.
5 mg/m2) for patients who do not achieve a CR/CRi. Subsequent cycles are 4 weeks in duration. Table 1. 5 Cycle length 28 dayse Abbreviations: ANC=absolute neutrophil counts; CR=complete remission; CRi=complete remission with incomplete haematological recovery.
a +/- 2 days (maintain minimum of 6 days between doses). e. 7-day treatment-free interval starting on Day 21). c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
d CRi is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, incomplete recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
e 7-day treatment-free interval starting on Day 21. 4). 8). If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated. Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
e. Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-haematological toxicities. Table 2. Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1) Haematological toxicity Toxicity and dose modification(s) Levels prior to BESPONSA treatment: ANC was ≥ 1 × 109/L If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Summary of the safety profile in adult patients The most common (≥ 20%) adverse reactions in adult patients were thrombocytopenia (51%), neutropenia (49%), infection (48%), anaemia (36%), leukopenia (35%), fatigue (35%), haemorrhage (33%), pyrexia (32%), nausea (31%), headache (28%), febrile neutropenia (26%), increased 10 transaminases (26%), abdominal pain (23%), increased gamma-glutamyltransferase (21%), and hyperbilirubinaemia (21%).
In adult patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection (23%), febrile neutropenia (11%), haemorrhage (5%), abdominal pain (3%), pyrexia (3%), VOD/SOS (2%), and fatigue (2%). Tabulated list of adverse reactions Table 5 shows the adverse reactions reported in adult patients with relapsed or refractory ALL who received BESPONSA.
The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table
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). BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population.
This risk was most marked in patients who underwent subsequent HSCT. In the following subgroups, the reported frequency of VOD/SOS post-HSCT was ≥ 50%: - Patients who received a HSCT conditioning regimen containing 2 alkylating agents; - Patients aged ≥ 65 years; and - Patients with a serum bilirubin ≥ ULN prior to HSCT.
The use of HSCT conditioning regimens containing 2 alkylating agents should be avoided. The benefit/risk should be carefully considered before administering BESPONSA to patients in whom the future use of HSCT conditioning regimens containing 2 alkylating agents is likely unavoidable.
In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk. 2). Other patient factors that appear to be associated with an increased risk of VOD/SOS after HSCT include a prior HSCT, age ≥ 55 years, a history of liver disease and/or hepatitis before treatment, later salvage lines, and a greater number of treatment cycles.
Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT. No patients with relapsed or refractory ALL who were treated with BESPONSA in clinical studies had undergone HSCT within the previous 4 months.
3). 2). Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post-HSCT. Signs may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS.
1. - Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS). , cirrhosis, nodular regenerative hyperplasia, active hepatitis).
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Platelet count was ≥ 50 × 109/La If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La. ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La If ANC and/or platelet count decreases, interrupt the next cycle of treatment until at least one of the following occurs: - ANC and platelet count recover to at least baseline levels for the prior cycle, or - ANC recovers to ≥ 1 × 109/L and platelet count recovers to ≥ 50 × 109/La, or - Stable or improved disease (based on most recent bone marrow assessment) and the ANC and platelet count decrease is considered to be due to the underlying disease (not considered to be BESPONSA-related toxicity).
Abbreviation:
ANC=absolute neutrophil count. a Platelet count used for dosing must be independent of blood transfusion. Table 3. 4). 5 × ULN and […]
In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA. For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
For patients who proceed to HSCT, liver tests should be monitored closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice. 2). 2). If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
8). 8). 1), bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment. As appropriate, prophylactic antiinfectives should be administered and surveillance testing should be employed during and after treatment.
2). 8). 2). Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion-related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
If an infusion-related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted. 2). 2). 8). 2). Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
QT interval prolongation In patients receiving inotuzumab ozogamicin, […]