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Abbreviated Prescribing Information

BESPONSA® ABBREVIATED PACKAGE INSERT

  1. TRADE NAME: BESPONSA® (Inotuzumab ozogamicin)
  2. PRESENTATION: 1 mg powder for concentrate for solution for infusion
  3. INDICATIONS: Besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
  4. DOSAGE: For cycle 1, 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2). Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a CR/CRi, and/or to allow recovery from toxicity. For subsequent cycles, 1.5 mg/m2 per cycle given as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi. Subsequent cycles are 4 weeks in duration. For patients proceeding to haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles. A third cycle may be considered for those patients who do not achieve a CR/CRi and minimal residual disease (MRD) negativity after 2 cycles. For patients not proceeding to HSCT, up to a maximum of 6 cycles, may be administered. Patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment. Dose modification of Besponsa may be required based on individual safety and tolerability. Refer to the Package insert for complete recommendation.
  5. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS). Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis).
  6. WARNINGS & PRECAUTIONS: Traceability: The trade name and the batch number of the administered product should be clearly recorded in the patient file. Hepatotoxicity, including VOD/SOS: Besponsa significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in patients with relapsed or refractory ALL. Careful consideration is required before administering Besponsa to patients who have had a prior HSCT. The use of HSCT conditioning regimens containing 2 alkylating agents should be avoided. 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. 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. Patients with a history of liver disease should be carefully evaluated prior to treatment with Besponsa. For patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles. Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post HSCT. In all patients, liver tests should be monitored prior to and following each dose of Besponsa. Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of Besponsa. Treatment should be permanently discontinued if VOD/SOS occurs. If severe VOD/SOS occurs, the patient should be treated according to standard medical practice. Myelosuppression/cytopenias: Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection during treatment and after HSCT, bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment. As appropriate, prophylactic anti-infectives should be administered and surveillance testing should be employed during and after treatment. Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression may require a dosing interruption, dose reduction, or discontinuation of treatment. Infusion-related reactions: Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing. 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. Interrupt the infusion and institute appropriate medical management if an infusion related reaction occurs. Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines. For severe or life-threatening infusion reactions, treatment should be permanently discontinued. Tumor lysis syndrome (TLS): Pre-medication to reduce uric acid levels and hydration is recommended prior to dosing for patients with a high tumour burden. Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice. QT interval prolongation: Besponsa should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval and in patients with electrolyte disturbances. ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment. Increased amylase and lipase: Patients should be monitored for increases in amylase and lipase. Potential hepatobiliary disease should be evaluated and treated according to standard medical practice. Immunisations: Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of Besponsa treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle. Refer to the Package insert for complete recommendation.
  7. INTERACTIONS: No formal clinical drug interaction studies have been performed. The concomitant use of Besponsa with medicinal products known to prolong QT interval or to induce Torsades de Pointes should be carefully considered. The QT interval should be monitored in case of combinations of such medicinal products.
  8. PREGNANCY AND BREAST FEEDING: Women of childbearing potential should avoid becoming pregnant while receiving Besponsa. Women should use effective contraception during treatment with Besponsa and for at least 8 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment with Besponsa and for at least 5 months after the last dose. Besponsa must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus. Pregnant women, or patients becoming pregnant while receiving Besponsa, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the foetus. Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with Besponsa and for at least 2 months after the final dose. There is no information on fertility in patients. Both men and women must seek advice for fertility preservation before treatment.
  9. SIDE EFFECTS: Infection; Febrile neutropenia; Neutropenia; Thrombocytopenia; Leukopenia; Lymphopenia; Anaemia; Pancytopenia; Hypersensitivity; Decreased appetite; Tumour lysis syndrome; Hyperuricaemia; Headache; Haemorrhage; Abdominal pain; Vomiting; Diarrhoea; Nausea; Stomatitis; Constipation; Ascites; Abdominal distension; Hyperbilirubinaemia; Increased transaminases; Increased GGT; Venoocclusive liver disease (sinusoidal obstruction syndrome); Pyrexia; Fatigue; Chills; Increased alkaline phosphatase; ECG QT prolonged; Increased amylase; Increased lipase; Infusion related reaction. Refer to the Package insert for complete recommendation.

Reference: BESPONSA Hong Kong Prescribing Information (Version Nov 2018)
Date of Preparation: Oct 2019
Identifier Number: BESP1019
Full Prescribing Information is available upon request.