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Jaypirca Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs 50mg—30; 100mg—60
Manufacturer
Generic Availability
NO
Jaypirca Indications
Indications
In adults with relapsed or refractory mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a BTK inhibitor.
Jaypirca Dosage and Administration
Adult
Swallow whole. Take at the same time each day. 200mg once daily, until disease progression or unacceptable toxicity. Severe renal impairment (eGFR 15–29mL/min): reduce to 100mg once daily if current dose is 200mg once daily, otherwise reduce dose by 50mg; if current dose is 50mg once daily, then discontinue therapy. Concomitant strong CYP3A inhibitors (if unavoidable): reduce dose by 50mg; if current dose is 50mg once daily, then interrupt therapy for the duration of strong CYP3A inhibitor use. Concomitant moderate CYP3A inducers (if unavoidable): increase to 300mg if current dose is 200mg once daily; if current dose is 50mg or 100mg daily, then increase the dose by 50mg. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Jaypirca Contraindications
Not Applicable
Jaypirca Boxed Warnings
Not Applicable
Jaypirca Warnings/Precautions
Warnings/Precautions
Risk for serious hemorrhage (monitor); consider the benefit/risk of withholding treatment for 3–7 days pre- and post-surgery. Risk for serious infections (including bacterial, viral, or fungal) and opportunistic infections. Monitor for infections, evaluate promptly, and treat appropriately; consider antimicrobial prophylaxis or vaccinations in high risk patients. Monitor for cytopenias; obtain CBCs during therapy; interrupt, reduce dose, or discontinue as warranted. Monitor for cardiac arrhythmias (esp. in those with cardiac risk factors, hypertension, previous arrhythmias); manage appropriately. Second primary malignancies (eg, non-melanoma skin cancer, solid tumors, melanoma, others); advise to use sun protection; monitor. Severe renal impairment (eGFR 15–29mL/min): reduce Jaypirca dose (see Adults). Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Jaypirca Pharmacokinetics
Elimination
Following a single radiolabeled dose of pirtobrutinib 200mg to healthy subjects, 37% of the dose was recovered in feces (18% unchanged) and 57% in urine (10% unchanged). The effective half-life of pirtobrutinib is ~19 hours.
Jaypirca Interactions
Interactions
Concomitant strong CYP3A inhibitors may increase risk of pirtobrutinib toxicities (eg, itraconazole); avoid use. If concomitant strong CYP3A inhibitors is unavoidable, reduce pirtobrutinib dose (see Adults). Concomitant moderate or strong CYP3A inducers may reduce pirtobrutinib efficacy (eg, efavirenz, bosentan, rifampin); avoid use. If concomitant moderate CYP3A inducers is unavoidable, increase pirtobrutinib dose (see Adults). Concomitant sensitive P-gp, CYP2C8, BCRP, CYP2C19, or CYP3A substrates may increase risk of adverse reactions related to substrates (eg, digoxin, repaglinide, rosuvastatin, omeprazole, midazolam). Caution with antithrombotic agents; monitor for bleeding.
Jaypirca Adverse Reactions
Adverse Reactions
Fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, bruising, Grade 3/4 lab abnormalities (decreased neutrophil count, decreased lymphocyte count, decreased platelet count).
Jaypirca Clinical Trials
See Literature
Jaypirca Note
Not Applicable
Jaypirca Patient Counseling
See Literature
