JAYPIRCA

What it is

JAYPIRCA is pirtobrutinib film-coated tablets , available in 50 mg and 100 mg strengths . Pirtobrutinib is a reversible, noncovalent inhibitor of Bruton's tyrosine kinase (BTK) . This medicinal product is subject to additional monitoring in Australia .

Approved indications

— Relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) in adult patients who have been previously treated with a covalent BTK inhibitor, as monotherapy .

Dosing overview

The recommended dose is 200 mg once daily, and treatment should be continued until disease progression or unacceptable toxicity . JAYPIRCA may be taken with or without food, and patients should take the dose at approximately the same time every day . Do not split, crush or chew the tablet . For patients with severe renal impairment (eGFR 15–29 mL/min), reduce the dose to 100 mg once daily if the current dose is 200 mg once daily, otherwise reduce the dose by 50 mg . No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment .

Key safety warnings

Serious infections, including fatal events, have occurred in patients treated with JAYPIRCA, with the most frequently reported Grade ≥3 infections being pneumonia, COVID-19 pneumonia, COVID-19, and sepsis . Bleeding events, including fatal events, have occurred in patients treated with JAYPIRCA, with and without thrombocytopenia, including Grade 3 or higher major bleeding events such as gastrointestinal and intracranial haemorrhage . Grade 3 or 4 cytopenias, including neutropenia, anaemia, and thrombocytopenia, have occurred in patients treated with JAYPIRCA; complete blood counts should be monitored during treatment as medically indicated . Atrial fibrillation and atrial flutter have been observed in patients treated with JAYPIRCA, particularly in patients with a history of atrial fibrillation and/or multiple cardiovascular comorbidities; monitor for signs and symptoms and obtain an electrocardiogram as medically indicated . Second primary malignancies have occurred in patients treated with JAYPIRCA, with the most frequent types being non-melanoma skin cancers; patients should be monitored for the appearance of skin cancers and advised to protect from sun exposure .

Contraindications

JAYPIRCA is contraindicated in patients with known hypersensitivity to pirtobrutinib or any of the excipients .

PBS listing

PBS listing information is not provided in the source documents.

Regulatory history

JAYPIRCA was first approved on 05 March 2026 . ARTG registrations were granted on 2026-03-05 for both the 50 mg formulation (ARTG 481185) and the 100 mg formulation (ARTG 483365), both in licence category RE (registered export) .