Drug Action
Dinutuximab beta is a chimeric monoclonal antibody; it specifically targets the carbohydrate moiety of disialoganglioside 2, which is overexpressed on neuroblastoma cells.
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Drug reference
Dinutuximab beta is a chimeric monoclonal antibody; it specifically targets the carbohydrate moiety of disialoganglioside 2, which is overexpressed on neuroblastoma cells.
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High-risk neuroblastoma (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature)
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Acute grade 3 or 4, or extensive chronic graft-versus-host disease
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Avoid vaccinations during and for at least 10 weeks after treatment cessation (increased risk of immune stimulation and neurological toxicity). ensure absence of systemic infection—any other infection should be controlled before treatment initiation. pre-medication must be administered to minimise the risk of infusion- related reactions and neuropathic pain CAUTIONS, FURTHER INFORMATION ▶Pre-medication Severe infusion-related reactions can occur and dinutuximab beta should only be administered when appropriately trained staff and resuscitation facilities are immediately available; manufacturer advises pre- medication with an antihistamine, and to monitor closely, particularly during the first and second treatment course; discontinue immediately if reaction occurs and treat as indicated—consult product literature. Manufacturer advises pre-medication with non-opioid analgesics, gabapentin and opioids—consult product literature.
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NICE decisions ▶Dinutuximab beta for treating neuroblastoma (August 2018) NICE TA538 Dinutuximab beta (Qarziba ®) is recommended as an option for treating high-risk neuroblastoma in people aged 12 months and over whose disease has at least partially responded to induction chemotherapy, followed by myeloablative therapy and stem cell transplant, only if: . they have not already had anti-GD2 immunotherapy, and . the manufacturer provides dinutuximab beta 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/ta538 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2105 The Scottish Medicines Consortium has advised (November 2018) that dinutuximab beta (Qarziba ®) is accepted for use within NHS Scotland for the treatment of high-risk neuroblastoma in patients aged 12 months and over whose disease has at least partially responded to induction chemotherapy, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with a history of relapsed or refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2. 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 Abdominal distension. anaemia. anxiety. appetite decreased. ascites. capillary leak syndrome. chills. cough. cytokine release syndrome. decreased leucocytes. device related infection. dizziness. dyspnoea. electrolyte imbalance. eye disorders. eye inflammation. fever. fluid imbalance. gastrointestinal disorders. haematuria. headache. heart failure. hyperhidrosis. hypersensitivity. hypertension. hypertriglyceridaemia. hypoalbuminaemia. hypotension. hypoxia. increased risk of infection. left ventricular dysfunction. muscle spasms. nausea. neutropenia. oedema. oral disorders. pain. paraesthesia. pericardial effusion. peripheral neuropathy. photosensitivity reaction . pulmonary oedema. renal impairment. respiratory disorders. seizure. sepsis. skin reactions. tachycardia. thrombocytopenia. tremor. urinary retention. urine abnormalities. vision disorders. vomiting. weight changes ▶Uncommon Disseminated intravascular coagulation. eosinophilia. hepatocellular injury. hypovolaemic shock. intracranial pressure increased. peripheral vascular disease. posterior reversible encephalopathy syndrome (PRES)
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Manufacturer advises women of childbearing potential should use contraception during and for 6 months after stopping treatment. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid during treatment and for 6 months after the last dose—no information available.
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▶Manufacturer advises pre-treatment evaluation of pulse oximetry, bone marrow function, liver function and renal function—consult product literature for values required for treatment initiation. ▶Manufacturer advises monitor circulatory and respiratory function—risk of capillary leak syndrome. ▶Manufacturer advises monitor liver function and electrolytes regularly. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C)—consult product literature for further information regarding storage conditions outside refrigerator and after preparation of the infusion.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Qarziba (EUSA Pharma Ltd) A Dinutuximab beta 4.5 mg per 1 ml Qarziba 20mg/4.5ml concentrate for solution for infusion vials | 1 vial P £7,610.00 (Hospital only)
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Driving and skilled tasks Manufacturer advises patients should not use or drive machines during treatment.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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