pirtobrutinib
Jaypirca · ATC code L01
- Key facts
- Active substance
- pirtobrutinib
- ATC code
- L01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Jaypirca 50 mg film-coated tablets / Jaypirca 100 mg film-coated tablets
- Marketing authorisation holder
- Eli Lilly Nederland B.V.
- Information as of
- 2026-10-28
Key facts
Pirtobrutinib (Jaypirca) is an oral Bruton's tyrosine kinase (BTK) inhibitor used to treat mantle cell lymphoma and chronic lymphocytic leukaemia.
What it is used for
- Monotherapy of relapsed or refractory mantle cell lymphoma in adults previously treated with a BTK inhibitor.
- Monotherapy of chronic lymphocytic leukaemia (CLL) in adults; see the full text for the exact wording.
Dosing
- 200 mg once daily at about the same time, with or without food; tablet swallowed whole with a glass of water.
- Interrupt until recovery for e.g. Grade 3 neutropenia with fever/infection, Grade 4 neutropenia lasting ≥ 7 days, Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia, and Grade 3 or 4 non-haematologic toxicity.
- Asymptomatic lymphocytosis is not an adverse reaction; treatment continues.
- Missed dose: not made up after more than 12 hours; no extra dose after vomiting.
- No dose adjustment for age or for renal or hepatic impairment of any degree.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Serious infections, including fatal cases (mainly pneumonia, COVID-19, sepsis); consider prophylaxis at increased risk.
- Haemorrhage, including fatal, gastrointestinal and intracranial bleeding; higher risk with anticoagulants or antiplatelets; consider withholding for 3 to 5 days around surgery.
- Cytopenias: monitor blood counts.
- Atrial fibrillation/flutter, particularly with cardiac history; ECG as indicated.
- Second primary malignancies, mostly non-melanoma skin cancer (sun protection); tumour lysis syndrome can occur.
Side effects
- Most common: neutropenia (27.4 %) and haemorrhage (20.4 %).
- Most common severe reactions: neutropenia (22.8 %), anaemia (9.0 %), pneumonia (8.8 %) and thrombocytopenia (7.2 %).
- Serious adverse reactions in 18.0 %, most often pneumonia (8.2 %).
Interactions
- Avoid strong CYP3A inducers (e.g. rifampicin, carbamazepine, phenytoin) if possible; rifampin decreased AUC by 71 %.
- No dose adjustment is needed with CYP3A inhibitors.
- Anticoagulants and antiplatelet agents increase bleeding risk.
Pregnancy and breastfeeding
- Can cause foetal harm; should not be used in pregnancy. Women should use contraception for 5 weeks and men for 3 months after the last dose.
- Breast-feeding should be discontinued during treatment and for one week after the last dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- JaypircaEli Lilly Nederland B.V. · EMEA/H/C/005863
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Jaypirca
- Liechtenstein
- Jaypirca
- Norway
- Jaypirca
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
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Sources
- European Medicines Agency. Jaypirca – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.