Drug Action
Inotuzumab ozogamicin is a monoclonal antibody that binds to CD22-expressing tumour cells to induce cell cycle arrest and apoptotic cell death.
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Drug reference
Inotuzumab ozogamicin is a monoclonal antibody that binds to CD22-expressing tumour cells to induce cell cycle arrest and apoptotic cell death.
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Monotherapy for relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (under expert supervision) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature) Immune system and malignant disease
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Prior confirmed severe or ongoing sinusoidal obstruction syndrome
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History of, or predisposition to QT-interval prolongation (e.g. electrolyte disturbances, concomitant use of drugs that prolong the QT interval). patients may need pre-medication to minimise adverse reactions. patients undergoing haematopoietic stem cell transplantation (increased risk of hepatotoxicity) CAUTIONS, FURTHER INFORMATION ▶Pre-medication Manufacturer advises pre-medication with a corticosteroid, antipyretic and antihistamine prior to dosing in all patients and pre-medication to reduce uric acid levels and hydration in patients with a high tumour burden (increased risk of tumour lysis syndrome)—consult product literature.
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Manufacturer advises baseline CD22 positivity of greater than 0% is required prior to initiating treatment.
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Inotuzumab ozogamicin is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1; manufacturer advises to record the brand name and batch number after each administration. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light—consult product literature for storage conditions after reconstitution and dilution.
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NICE decisions ▶Inotuzumab ozogamicin for treating relapsed or refractory B- cell acute lymphoblastic leukaemia (September 2018) NICE TA541 Inotuzumab ozogamicin (Besponsa ®) is recommended, within its marketing authorisation, as an option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults. People with relapsed or refractory Philadelphia-chromosome- positive disease should have had at least 1 tyrosine kinase inhibitor. Inotuzumab ozogamicin is recommended only if the manufacturer provides it according to the commercial arrangement. www.nice.org.uk/guidance/ta541 Scottish Medicines Consortium (SMC) decisions SMC No. 1328/18 The Scottish Medicines Consortium has advised (June 2018) that inotuzumab ozogamicin (Besponsa ®) is accepted for restricted use within NHS Scotland as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL) for whom the intent is to proceed to stem cell transplantation. Adults with Philadelphia chromosome positive relapsed or refractory B cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Anaemia. appetite decreased. ascites. bone marrow disorders. central nervous system haemorrhage. chills. constipation. decreased leucocytes. diarrhoea. fatigue. fever. gastrointestinal discomfort. haemorrhage. headache. hyperbilirubinaemia. hypersensitivity. hyperuricaemia. increased risk of infection. infusion related reaction. nausea. neutropenia. QT interval prolongation. sepsis. sinusoidal obstruction syndrome. stomatitis. thrombocytopenia. tumour lysis syndrome. vomiting SIDE-EFFECTS, FURTHER INFORMATION Manufacturer advises interrupt treatment if an infusion related reaction occurs; depending on the severity, discontinuation of the infusion or administration of steroids and antihistamines should be considered (consult product literature); permanently discontinue treatment in severe or life- threatening infusion reactions.
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for at least 8 months after the last dose; male patients should use effective contraception during treatment and for at least 5 months after the last dose if their partner is of childbearing potential. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies.
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Manufacturer advises avoid during treatment and for at least two months after the last dose— no information available.
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Manufacturer advises caution if bilirubin and transaminase levels are raised (limited information available); avoid in serious ongoing impairment. Dose adjustments Manufacturer advises dose interruption or discontinuation according to bilirubin and transaminase levels.
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▶Manufacturer advises monitor complete blood counts prior to each dose as well as signs and symptoms of infection, bleeding and other effects of myelosuppresion during treatment; dose reduction or interruption or discontinuation of treatment may be required—consult product literature. ▶Manufacturer advises monitor for signs of infusion related-reactions during and for at least 1 hour after infusion; monitor for signs and symptoms of tumour lysis syndrome. ▶Manufacturer advises ECG and electrolytes should be monitored prior to the start of treatment and periodically Immune system and malignant disease during treatment; monitor for increases in serum amylase and lipase. ▶Manufacturer advises monitor for signs and symptoms of sinusoidal obstruction syndrome; liver tests should be monitored prior to and following each dose—consult product literature.
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Manufacturer advises resuscitation facilities should be available during administration.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ELECTROLYTES: May contain Sodium ▶Besponsa (Pfizer Ltd) A Inotuzumab ozogamicin 1 mg Besponsa 1mg powder for concentrate for solution for infusion vials | 1 vial P £8,048.00 (Hospital only)
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Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of fatigue.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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