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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.
“Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity.”
“Following a single oral dose of 100 mg acalabrutinib tablet, the median terminal elimination half-life (t½) of acalabrutinib was 1.3 (range: 0.8 to 9.0) hours. The median t½ of the active metabolite, ACP-5862, was 7.3 hours (range: 2.5 to 10.1) hours.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“In vitro, acalabrutinib is predominantly metabolised by CYP3A enzymes, and to a minor extent by glutathione conjugation and amide hydrolysis.”