Jaypirca

Jaypirca therapy should be initiated and supervised by physicians experienced in the use of anticancer therapies. Posology The recommended dose is 200 mg pirtobrutinib once daily (QD). Jaypirca dosing should be interrupted until recovery to Grade 1 or baseline when the patient experiences the following event: • Grade 3 neutropenia with fever and/or infection • Grade 4 neutropenia lasting ≥ 7 days • Grade 3 thrombocytopenia with bleeding • Grade 4 thrombocytopenia • Grade 3 or 4 non-haematologic toxicity Asymptomatic lymphocytosis is not regarded as an adverse reaction, and patients experiencing this event should continue taking Jaypirca.

1). Treatment should be continued until disease progression or unacceptable toxicity. Missed dose If more than 12 hours have passed after a patient has missed a dose, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.

If vomiting occurs, the patient should not take an additional dose but continue with the next scheduled dose. 2). Renal impairment No dose adjustment is required for patients with mild, moderate or severe renal impairment. 2). 2). Paediatric population The safety and efficacy of Jaypirca in children and adolescents aged less than 18 years have not been established.

No data are available. Method of administration Jaypirca is for oral use. The tablet should be swallowed whole with a glass of water to ensure consistent performance (patients should not chew, crush, or split tablets before swallowing) and can be taken with or without food.

Patients should take the dose at approximately the same time every day. 4

8 %). 0 %). 8 %. 4 %). 4 %). 0 %). 1 % of patients (1 patient) for urinary tract infection. Tabulated list of adverse reactions Table 1 lists the adverse drug reactions (ADRs) associated with Jaypirca used as a monotherapy from clinical study data and post-marketing experience.

The ADRs identified from clinical trials are based on pooled data from 690 patients treated with Jaypirca monotherapy 200 mg QD starting dose with no dose escalation in a phase 1/2 clinical study, and from patients treated with Jaypirca monotherapy 200 mg QD in a phase 3 study.

Patients were treated for MCL, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and other non-Hodgkin lymphoma (NHL). Patients were exposed to Jaypirca for a median duration of 12 months. ADRs are listed below by MedDRA body system organ class.

Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), and not known (cannot be estimated from the available data).

Within each frequency grouping, ADRs are presented in order of decreasing seriousness. 0 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Infections Serious infections, including fatal cases, have occurred in patients treated with Jaypirca. The most frequently reported Grade 3 or higher infections were pneumonia, COVID-19 pneumonia, COVID-19, and sepsis. Prophylactic antimicrobial therapy should be considered in patients who are at increased risk for opportunistic infections.

2). Haemorrhage Bleeding events, including fatal cases, have occurred in patients treated with Jaypirca, with and without thrombocytopenia. Major bleeding events of Grade 3 or higher, including gastrointestinal bleeding and intracranial haemorrhage have been observed.

Patients should be monitored for signs and symptoms of bleeding. Patients receiving anticoagulant or antiplatelet agents may be at increased risk of haemorrhage. The risks and benefits of anticoagulant or antiplatelet therapy should be considered when co-administered with Jaypirca and consider additional monitoring for signs of bleeding.

The use of Jaypirca has not been studied with warfarin or other vitamin K antagonists. 2). The benefit-risk of withholding Jaypirca for 3 to 5 days pre- and post-surgery should be considered depending upon the type of surgery and risk of bleeding.

Cytopenias Grade 3 or 4 cytopenias, including neutropenia, anaemia and thrombocytopenia occurred in patients treated with Jaypirca. Complete blood counts should be monitored in patients during treatment as medically indicated. 2). Atrial fibrillation/ flutter 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.

Signs and symptoms of atrial fibrillation and atrial flutter should be monitored in patients; obtain an electrocardiogram as medically indicated. 2). Second primary malignancies Second primary malignancies have commonly occurred in patients treated with Jaypirca, with the most frequent types being non-melanoma skin cancers.

1.