Blinatumomab


Concise Prescribing Info
Indications/Uses
Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia.
Dosage/Direction for Use
Adult : IV Patient with relapsed or refractory cases ≥45 kg: Cycle 1: 9 mcg/day given on days 1-7, followed by 28 mcg/day given on days 8-28. Cycle 2: 28 mcg/day given on days 1-28; <45 kg: Cycle 1: 5 mcg/m2 up to Max 9 mcg/day given on days 1-7, followed by 15 mcg/m2 up to Max 28 mcg/day given on days 8-28. Cycle 2: 15 mcg/m2 up to Max 28 mcg/day given on days 1-28. If complete remission is achieved after 2 cycles, may give additional 3 consolidation treatment cycles, based on individual benefits-risks assessment. Patient with minimal residual disease (MRD) ≥0.1%: ≥45 kg: Cycles 1-4: 28 mcg/day given on days 1-28; <45 kg: Cycles 1-4: 15 mcg/m2 up to Max 28 mcg/day given on days 1-28. Each treatment cycle lasts for 42 days consisting of 28 days continuous infusion followed by 14 days treatment-free interval. All doses are given via continuous IV infusion. Premedicate with dexamethasone prior to therapy. Dose reduction, interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Dosage Details
Intravenous
Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukaemia
Adult: Patient with relapsed or refractory cases ≥45 kg: Cycle 1: 9 mcg daily given on days 1-7, followed by 28 mcg daily given on days 8-28. Cycle 2: 28 mcg daily given on days 1-28; <45 kg: Cycle 1: 5 mcg/m2 up to Max 9 mcg daily given on days 1-7, followed by 15 mcg/m2 up to Max 28 mcg daily given on days 8-28. Cycle 2: 15 mcg/m2 up to Max 28 mcg daily given on days 1-28. If complete remission is achieved after 2 cycles, may give additional 3 consolidation treatment cycles, based on individual benefits-risks assessment. Patient with minimal residual disease (MRD) ≥0.1%: ≥45 kg: Cycles 1-4: 28 mcg daily given on days 1-28; <45 kg: Cycles 1-4: 15 mcg/m2 up to Max 28 mcg daily given on days 1-28. Each treatment cycle lasts for 42 days consisting of 28 days continuous infusion followed by 14 days treatment-free interval. All doses are given via continuous IV infusion. Premedicate with dexamethasone prior to therapy. Dose reduction, interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Child: Patient with relapse or refractory cases after at least 2 prior therapies, or in relapse following prior allogeneic hematopoietic stem cell transplantation: ≥1 year Same as adult dose.
Reconstitution
Reconstitute vial with 3 mL 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 detailed product guideline.
Contraindications
Lactation.
Special Precautions
Patient with history or presence of 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); higher leucocytosis or a high tumour burden. Renal and hepatic impairment. Children and elderly. Pregnancy. Concomitant use with live viral vaccines.
Adverse Reactions
Significant: Anaemia, thrombocytopenia, transient elevation in liver enzymes, leukoencephalopathy, progressive multifocal leukoencephalopathy, disseminated intravascular coagulation, capillary leak syndrome, haemophagocytic histiocytosis or macrophage activation syndrome.
Blood and lymphatic system disorders: Leukocytosis.
Cardiac disorders: Tachycardia, arrhythmia.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, abdominal pain.
General disorders and admin site conditions: Chills, ataxia.
Immune system disorders: Hypersensitivity.
Infections and infestations: Bacterial, fungal and viral infections.
Investigations: Decreased immunoglobulins, weight increased.
Musculoskeletal and connective tissue disorders: Back pain, pain in extremity, bone pain.
Nervous system disorders: Headache, tremor, somnolence, dizziness, paraesthesia.
Psychiatric disorders: Insomnia, aphasia.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea, respiratory failure.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: 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 site infections); neurological toxicities (e.g. encephalopathy, convulsions); pancreatitis; tumour lysis syndrome.
Patient Counseling Information
This drug may cause confusion and disorientation, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor CBC with differential, LFTs, serum uric acid, electrolytes and neurological exam at baseline and during therapy. Assess for signs and symptoms of infection, neurotoxicity, tumour lysis syndrome, pancreatitis, cytokine release syndrome and infusion-related reactions.
Overdosage
Symptoms: Headache, fever, and tremors. Management: Temporarily interrupt infusion and provide supportive treatment. Reinitiate therapy no earlier than 12 hours after infusion interruption.
Drug Interactions
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).
Action
Description: Blinatumomab, a bispecific T-cell engager (BiTE) monoclonal antibody, binds to CD19 expressed on B-cells and CD3 expressed on T-cells which then 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.
Excretion: Via urine (negligible amounts). Elimination half-life: 2.1 hours.
Storage
Store between 2-8°C. Do not freeze. Protect from light. This is a cytotoxic drug. Any unused portions should be disposed of in accordance with local requirements.
ATC Classification
L01XC19 - blinatumomab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by MIMS based on Blinatumomab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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