Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.
Jaypirca therapy should be initiated and supervised by physicians experienced in the use of anticancer therapies.
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:
Asymptomatic lymphocytosis is not regarded as an adverse reaction, and patients experiencing this event should continue taking Jaypirca.
In the clinical study, adverse events in a limited number of patients were managed by dose reduction (see section 5.1).
Treatment should be continued until disease progression or unacceptable toxicity.
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.
No dose adjustment is required based on age (see section 5.2).
No dose adjustment is required for patients with mild, moderate or severe renal impairment. There are no data in patients on dialysis (see section 5.2).
No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment (see section 5.2).
The safety and efficacy of Jaypirca in children and adolescents aged less than 18 years have not been established. No data are available.
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.
No maximum tolerated dose was reached in the phase 1 study in which patients received repeated doses up to 300 mg once daily. In healthy volunteer studies, no dose related toxicity was observed when a maximum single dose of 900 mg was administered. Signs and symptoms of pirtobrutinib overdose have not been established and there is no specific treatment for pirtobrutinib overdose. For patients who experience overdose, closely monitor and provide appropriate supportive treatment.
2 years.
This medicinal product does not require any special storage conditions.
Jaypirca 50 mg film-coated tablets: Polyvinylchloride/polychlorotrifluoroethylene blisters sealed with an aluminium foil in packs of 28, 30 or 84 film-coated tablets.
Jaypirca 100 mg film-coated tablets: Polyvinylchloride/polychlorotrifluoroethylene blisters sealed with an aluminium foil in packs of 28, 30, 56, 60, 84 or 168 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
