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Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Clinical criteria: Treatment Phase: Continuing treatment (Cycles 2-12) Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND The treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components, AND Patient must not have developed disease progression while being treated with this drug for this condition, AND The treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.
“Glofitamab is a bispecific monoclonal antibody that binds bivalently (with high avidity) to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells.”
“The effective half-life in the linear phase (i.e., after the contribution of time-varying clearance has collapsed to a negligible amount) is 7.92 days (geometric mean, 95% CI: 4.69, 11.90) based on the population pharmacokinetic analysis.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Though the initial release of cytokines associated with the start of COLUMVI treatment could suppress CYP450 enzymes, these changes would be transient as cytokine release is only observed with the first doses of COLUMVI. The highest drug-drug interaction risk is during the period of one week following each of the first 2 doses of COLUMVI (i.e., Cycle 1 Day 8 and 15) in patients who are receiving concomitant CYP450 substrates with a narrow therapeutic index (e.g., warfarin, cyclosporine).”