IntravenousRefractory CD19-positive B-cell precursor acute lymphoblastic leukaemia, Relapsed CD19-positive B-cell precursor acute lymphoblastic leukaemiaAdult: Treatment course: 2 induction cycles followed by 3 consolidation cycles and up to 4 additional cycles of continued therapy. Patients weighing ≥45 kg: Induction cycle 1: 9 mcg daily on Days 1-7, then 28 mcg daily on days 8-28. Induction cycle 2: 28 mcg daily on Days 1-28. Consolidation cycles 3-5: 28 mcg daily on days 1-28. Continued therapy cycles 6-9: 28 mcg daily on Days 1-28. Patients weighing <45 kg: Induction cycle 1: 5 mcg/m2 daily (not to exceed 9 mcg daily) on Days 1-7, then 15 mcg/m2 daily (not to exceed 28 mcg daily) on Days 8-28. Induction cycle 2: 15 mcg/m2 daily (not to exceed 28 mcg daily) on Days 1-28. Consolidation cycles 3-5: 15 mcg/m2 daily (not to exceed 28 mcg daily) on Days 1-28. Continued therapy cycles 6-9: 15 mcg/m2 daily (not to exceed 28 mcg daily) on Days 1-28. Each induction or consolidation cycle, and continued therapy cycle is followed by a 14-day treatment-free interval (on Days 29-42 for induction or consolidation cycle; Days 29-84 for continued therapy cycle). All doses are given via continuous IV infusion. Premedicate with dexamethasone 1 hour before initiation of each cycle. Dose reduction, interruption, or discontinuation may be required according to safety and tolerability (refer to specific product guidelines).
Child: Same as adult dose.
IntravenousMinimal residual disease-positive CD19-positive B-cell precursor acute lymphoblastic leukaemiaAdult: In Philadelphia chromosome-negative patients with minimal residual disease ≥0.1% in 1st or 2nd complete remission weighing ≥45 kg: Treatment course: 1 induction cycle followed by 3 consolidation cycles. Induction cycle 1: 28 mcg daily on Days 1-28. Consolidation cycles 2-4: 28 mcg daily on Days 1-28. All doses are given via continuous IV infusion. Each induction or consolidation cycle is followed by a 14-day treatment-free interval on Days 29-42. Premedicate with prednisone or equivalent dexamethasone 1 hour before initiation of each cycle. Dose reduction, interruption, or discontinuation may be required according to safety and tolerability; treatment recommendations may vary among countries and individual products (refer to specific product guidelines).
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Reconstitute vial with 3 mL preservative-free sterile water for inj to make a final concentration of 12.5 mcg/mL. Gently swirl, do not shake. For specific reconstitution and dilution instructions for each dose and infusion time, refer to the specific product guidelines.
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Patient with history or current clinically relevant CNS pathology (e.g. stroke, epilepsy, paresis, aphasia, severe brain injuries, Parkinson's disease, cerebellar disease, organic brain syndrome, dementia, psychosis); history of neurologic signs and symptoms (e.g. dizziness, hypoaesthesia, hyporeflexia, dysaesthesia, memory impairment); prior treatment with cranial irradiation and anti-leukaemic chemotherapy (e.g. systemic high dose methotrexate or intrathecal cytarabine). Patients with higher leucocytosis or a high tumour burden are recommended to receive aggressive hydration and anti-hyperuricaemic therapy. Renal and hepatic impairment. Children and elderly. Pregnancy.
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Significant: Transient elevation in liver enzymes, leucoencephalopathy; anaemia, thrombocytopenia, pyrexia, weight gain and hypertension especially in children; leucoencephalopathy including progressive multifocal leucoencephalopathy; disseminated intravascular coagulation, capillary leak syndrome, haemophagocytic histiocytosis or macrophage activation syndrome.
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting, constipation, abdominal pain.
General disorders and administration site conditions: Pyrexia, chills, oedema, pain.
Hepatobiliary disorders: Hyperbilirubinaemia.
Investigations: Decreased immunoglobulins, weight increase, increased blood alkaline phosphatase.
Musculoskeletal and connective tissue disorders: Back pain, pain in extremity, bone pain.
Nervous system disorders: Headache, tremor, aphasia, paraesthesia, cognitive disorder, memory impairment, dizziness, somnolence, hypoaesthesia, cranial nerve disorder, ataxia.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, productive cough, respiratory failure, wheezing, chest pain.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: Hypotension, hypertension, flushing.
Potentially Fatal: Bone marrow suppression (e.g. neutropenia and febrile neutropenia); cytokine release syndrome; serious infections (e.g. sepsis, pneumonia, bacteraemia, opportunistic and catheter-related infections); neurological toxicities (e.g. encephalopathy, convulsions); pancreatitis; tumour lysis syndrome.
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This drug may cause confusion, disorientation, co-ordination and balance disorders, seizures and disturbances in consciousness; if affected, do not drive or operate machinery. Women of childbearing potential must use proven birth control methods during therapy and for at least 48 hours after treatment.
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Verify pregnancy status before treatment initiation. Monitor CBC with differential, LFTs at baseline and during therapy. Monitor for signs and symptoms of infection, neurotoxicity, tumour lysis syndrome, pancreatitis, cytokine release syndrome, and infusion-related reactions.
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Symptoms: Headache, fever, and tremors. Management: Supportive treatment. Temporarily interrupt infusion and monitor signs of adverse reaction. Reinitiate therapy no earlier than 12 hours after infusion interruption.
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May enhance adverse effect of live viral vaccines. May alter the serum concentration or increase risk of toxic effect of CYP450 substrates with narrow therapeutic index (e.g. warfarin, ciclosporin).
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Description:
Mechanism of Action: Blinatumomab, a bispecific T-cell engager monoclonal antibody which binds to CD19 expressed on B-cells and CD3 expressed on T-cells. It activates endogenous T-cells by connecting CD3 in the T-cell receptor complex with the CD19 on benign and malignant B-cells, thereby forming a cytolytic synapse between a cytotoxic T-cell and a cancer target B-cell. It mediates the production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells; resulting in the lysis of CD 19-positive cells.
Pharmacokinetics:
Distribution: Volume of distribution: 4.35 L.
Metabolism: Metabolised into small peptides and amino acids via catabolic pathways.
Excretion: Via urine (negligible amounts). Elimination half-life: 2.1 hours.
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Intact vials: Store between 2-8°C. Do not freeze. Protect from light. Reconstituted solution: Stable between 2-8°C for up to 24 hours, or between 23-27°C for up to 4 hours. Diluted solution: Stable between 2-8°C for 10 days or <27°C for 96 hours. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration and disposal.
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L01FX07 - blinatumomab ; Belongs to the class of other monoclonal antibodies and antibody drug conjugates. Used in the treatment of cancer.
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Anon. Blinatumomab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/11/2022. Blincyto 38.5 micrograms Powder for Concentrate and Solution for Infusion (Amgen Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/11/2022. Blincyto for Injection 35 mcg/vial (Amgen Biopharmaceuticals Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/11/2022. Blincyto Kit (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/11/2022. Buckingham R (ed). Blinatumomab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/11/2022. Joint Formulary Committee. Blinatumomab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/11/2022.
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