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Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Clinical criteria: Treatment Phase: Treatment of relapsed/refractory disease The condition must have relapsed or be refractory to at least one prior therapy, AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication. Treatment criteria: Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression, AND Patient must be undergoing treatment through this treatment phase listing for the first time (initial treatment); OR Patient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent, AND Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
Mantle cell lymphoma Clinical criteria: Treatment Phase: Initial treatment The condition must have relapsed or be refractory to at least one prior therapy, AND Patient must have a WHO performance status of 0 or 1, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must be untreated with Bruton's tyrosine kinase inhibitor therapy; OR Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. Treatment criteria: Must be treated by a medical practitioner.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Remibrutinib is an oral, BTK inhibitor. It inhibits mast cells and basophil degranulation mediated by pathogenic IgE or IgG directed against the FcεRI or IgE.”
“Remibrutinib had a mean elimination half-life ranging between 1 and 2 hours at steady state.”
“Remibrutinib is metabolised primarily by CYP3A4, leading to the formation of 18 inactive metabolites, all in low amounts in circulation.”
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