Drug Action
The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
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Drug reference
The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
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Relapsed or refractory Philadelphia chromosome- negative acute lymphoblastic leukaemia (initiated by a specialist) ▶BY CONTINUOUS INTRAVENOUS INFUSION ▶Adult: (consult product literature) Philadelphia chromosome-negative acute lymphoblastic leukaemia in complete remission with minimal residual disease (initiated by a specialist) ▶BY CONTINUOUS INTRAVENOUS INFUSION ▶Adult (body-weight 45 kg and above): (consult product literature)
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Aphasia. brain injuries (severe). cerebellar disease. dementia. elderly—limited information available . epilepsy. paresis. Parkinson’s disease. patients may need pre-medication to minimise adverse reactions. psychosis. seizure. severe hepatic impairment. severe renal impairment. stroke CAUTIONS, FURTHER INFORMATION ▶Pre-medication Manufacturer advises pre-medication with a corticosteroid and an anti-pyretic—consult product literature. ▶Neurological events There is potentially a higher risk of neurological events in patients with clinically relevant CNS pathology—manufacturer advises caution.
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NICE decisions ▶Blinatumomab for previously treated Philadelphia- chromosome-negative acute lymphoblastic leukaemia (June 2017) NICE TA450 Blinatumomab (Blincyto ®) is recommended within its marketing authorisation as an option for treating Philadelphia chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta450 ▶Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity (July 2019) NICE TA589 Blinatumomab (Blincyto ®) is recommended as an option for treating Philadelphia chromosome-negative CD19- positive B-precursor acute lymphoblastic leukaemia in adults with minimal residual disease of at least 0.1%, only if: . the disease is in first complete remission, and . the manufacturer provides blinatumomab 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/ta589 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2234 The Scottish Medicines Consortium has advised (March 2020) that blinatumomab (Blincyto ®) is accepted for Immune system and malignant disease restricted use within NHS Scotland as monotherapy for the treatment of Philadelphia chromosome-negative, CD19 positive, B-precursor acute lymphoblastic leukaemia in adults who are in first complete remission with minimal residual disease greater than or equal to 0.1%. 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 pain. anaemia. aphasia. appetite decreased. arthralgia. chest pain. chills . cognitive disorder. confusion. constipation. cough. decreased leucocytes. diarrhoea. dizziness. dyspnoea. electrolyte imbalance. encephalopathy. facial swelling. fatigue. fever. flushing. headache. hyperglycaemia. hypersensitivity. hypertension. hypoalbuminaemia. hypotension. immune disorder. increased risk of infection . infusion related reaction. insomnia. leucocytosis. memory loss. nausea. neutropenia. oedema. pain. paraesthesia. rash. respiratory disorders. seizure. sepsis. tachycardia. thrombocytopenia. tremor. tumour lysis syndrome. vomiting. weight increased ▶Uncommon Capillary leak syndrome. cranial nerve disorder. pancreatitis SIDE-EFFECTS, FURTHER INFORMATION Pancreatitis Life- threatening or fatal cases of pancreatitis have been reported; manufacturer advises monitor for signs and symptoms of pancreatitis during treatment—temporary interruption or discontinuation may be required (consult product literature). Cytokine release syndrome, infusion-reactions and tumour lysis syndrome Life-threatening (including fatal) cases of cytokine release syndrome and tumour lysis syndrome have been reported in patients taking blinatumomab. Manufacturer advises monitor signs and symptoms of cytokine release syndrome and infusion reactions during treatment; temporary interruption or Immune system and malignant disease discontinuation may be required—consult product literature.
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Manufacturer advises effective contraception during treatment and for at least 48 hours after treatment in women of child-bearing potential. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless potential benefit outweighs risk—no information available; if exposed during pregnancy, monitor infant for B-cell depletion. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid during and for at least 48 hours after treatment—no information available.
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Manufacturer advises caution in severe impairment (no information available).
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Manufacturer advises caution in severe impairment—no information available.
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Manufacturer advises neurological examination prior to the initiation of treatment and continued monitoring during treatment— consult product literature. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C); consult product literature for storage conditions after reconstitution and dilution.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion EXCIPIENTS: May contain Polysorbates ▶Blincyto (Amgen Ltd) A Blinatumomab 38.5 microgram Blincyto 38.5micrograms powder for concentrate and solution for solution for infusion vials | 1 vial P £2,017.00
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A patient alert card should be provided. Educational materials should be provided to patients, carers and healthcare professionals to ensure blinatumomab is used in a safe and effective way, and to prevent the risk of medication errors and neurological events—consult product information. Driving and skilled tasks Manufacturer advises patients and carers should be counselled about the effects on driving and performance of skilled tasks—increased risk of confusion, disorientation, co-ordination and balance disorders, seizures and disturbances in consciousness.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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(consult product
First-line fragment. Read the complete Indications and Dose section above.
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