Initial US Approval:
2013
Key Clinical Studies:
BRUIN-CLL-321 (NCT 04666038)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
JAYPIRCA® is a kinase inhibitor indicated for the treatment of:
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.
Dosage and Administration:
- Recommended dosage: 200 mg orally once daily; swallow whole with water, with or without food. Do not cut, crush, or chew tablets.
- Manage toxicity using treatment interruption, dosage reduction, or discontinuation.
- Reduce dose in patients with severe renal impairment.
Dosage Forms and Strengths:
Tablets: 50 mg, 100 mg.
Contraindications:
None.
Warnings and Precautions:
- Infections: Monitor for signs and symptoms of infection, evaluate promptly, and treat.
- Hemorrhage: Monitor for bleeding and manage appropriately.
- Cytopenias: Monitor complete blood counts during treatment.
- Cardiac Arrythmias: Monitor for symptoms of arrhythmias and manage appropriately.
- Second Primary Malignancies: Other malignancies have developed, including skin cancers and other carcinomas. Monitor and advise patients to use sun protection.
- Hepatotoxicity, Including Drug-Induced Liver Injury: Monitor hepatic function throughout treatment.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.
Adverse Reactions:
Most common adverse reactions (≥ 30%), including laboratory abnormalities, are fatigue, neutrophil count decreased, platelet count decreased, hemoglobin decreased, leukocytes decreased, lymphocyte count decreased and calcium decreased.
Drug Interactions:
- Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use is unavoidable, reduce the JAYPIRCA dose.
- Strong or Moderate CYP3A Inducers: Avoid concomitant use. If concomitant use of moderate CYP3A inducers is unavoidable, increase the JAYPIRCA dose.
- Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: For substrates where minimal concentration changes may increase the risk of adverse reactions, follow recommendations for co-administration with CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP inhibitors provided in their approved product labeling.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://pi.lilly.com/us/jaypirca-uspi.pdf?s=pi
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
