Drug Action
Gemtuzumab ozogamicin is a monoclonal antibody that binds to CD33-expressing tumour cells to induce cell cycle arrest and apoptotic cell death.
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Drug reference
Gemtuzumab ozogamicin is a monoclonal antibody that binds to CD33-expressing tumour cells to induce cell cycle arrest and apoptotic cell death.
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CD33-positive acute myeloid leukaemia (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature)
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Adverse-risk cytogenetics (consider benefits and risks of treatment, consult product literature). haematopoietic stem cell transplantation (increased risk of hepatotoxicity). pre-medication recommended to minimise adverse reactions CAUTIONS, FURTHER INFORMATION ▶Pre-medication Serious infusion-related reactions can occur and gemtuzumab ozogamicin should only be administered when appropriately trained staff and resuscitation facilities are immediately available; manufacturer advises pre-medication with a corticosteroid, paracetamol and antihistamine 1 hour prior to dosing, and to take appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia—consult product literature.
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Gemtuzumab 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. 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 ▶Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (November 2018) NICE TA545 Gemtuzumab ozogamicin (Mylotarg ®), with daunorubicin and cytarabine, is recommended as an option for untreated de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over, only if: . they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is, because the test was unsuccessful) or when their cytogenetic test results are not yet available, and . they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful), and . the manufacturer provides gemtuzumab ozogamicin according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta545 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2089 The Scottish Medicines Consortium has advised (October 2018) that gemtuzumab ozogamicin (Mylotarg ®) is accepted for restricted use within NHS Scotland as combination therapy with daunorubicin and cytarabine for the treatment of previously untreated, de novo CD33-positive acute myeloid leukaemia in patients aged 15 years and above with a favourable, intermediate or unknown cytogenetic profile.
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▶Common or very common Anaemia. appetite decreased. ascites. chills. constipation. decreased leucocytes. diarrhoea. dyspnoea. fatigue. fever. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headache. hepatic disorders. hyperbilirubinaemia. hyperglycaemia. hypertension. hypotension. infection. infusion related reaction (including fatal cases). multi organ failure. nausea. neutropenia. oedema. pancytopenia. sinusoidal obstruction syndrome. skin reactions. stomatitis. tachycardia. thrombocytopenia. tumour lysis syndrome (including fatal cases). vomiting ▶Frequency not known Interstitial pneumonia SIDE-EFFECTS, FURTHER INFORMATION Infusion-related reactions (including fatal cases) can occur during the first 24 hours after administration. Manufacturer advises interrupt treatment immediately and treat as clinically indicated (consult product literature); permanent discontinuation should be strongly considered in patients who develop signs and symptoms of anaphylaxis.
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Manufacturer advises women of childbearing potential should use 2 methods of effective contraception during treatment and for at least 7 months after the last dose; male patients should use 2 methods of effective contraception during treatment and for at least 4 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. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid during treatment and for at least one month after the last dose— no information available.
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Manufacturer advises caution in moderate-to-severe impairment—increased risk of developing hepatotoxicity; postpone treatment if serum transaminases (ALT or AST) greater than 2.5 times the upper limit of normal or total bilirubin greater than 2 times the upper limit of normal.
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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 myelosuppression during treatment; dose interruption or discontinuation of treatment may be required—consult product literature. ▶Manufacturer advises monitor for signs and symptoms of infusion-related reactions—close clinical monitoring, including pulse, blood pressure and temperature, should be performed during infusion; monitor for signs and symptoms of tumour lysis syndrome. ▶Manufacturer advises monitor for signs and symptoms of hepatotoxicity (including hepatic veno-occlusive disease); liver tests should be monitored prior to each dose—consult product literature.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Mylotarg (Pfizer Ltd) A Gemtuzumab ozogamicin 5 mg Mylotarg 5mg powder for concentrate for solution for infusion vials | 1 vial P £6,300.00 (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 and headache.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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