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Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used for the treatment of Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that specifically targets the CD19 antigen present on B cells. Blinatumomab is given via intravenous infusion.
Read the full article on WikipediaAcute lymphoblastic leukaemia Clinical criteria: Treatment Phase: Consolidation treatment Patient must have previously received PBS-subsidised induction treatment with this drug for this condition, AND Patient must have achieved a complete remission; OR Patient must have achieved a complete remission with partial haematological recovery, AND The treatment must not be more than 3 treatment cycles under this restriction in a lifetime, AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL) Clinical criteria: Treatment Phase: Initial treatment of Pre-B-cell ALL in complete haematological remission (CR) Treatment criteria: Must be treated by a physician experienced in the treatment of haematological malignancies. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, AND The condition must not be present in the central nervous system or testis, AND Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL); OR Patient must have: (i) achieved complete remission following intensive combination chemotherapy, (ii) measurable residual disease based on measurement in bone marrow, documented after the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods, AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and (4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
“Blinatumomab is a bispecific T-cell engager (BiTE). It enables a patient's T cells to recognize malignant B cells. A molecule of blinatumomab combines two binding sites: a CD3 site for T cells and a CD19 site for the target B cells. CD3 is part of the T cell receptor. The drug works by linking these two cell types and activating the T cell to exert cytotoxic activity on the target cell. CD3 and CD19 are expressed in both pediatric and adult patients, making blinatumomab a potential therapeutic option for both pediatric and adult populations.”
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