J-Parkar 50 mg (Pirtobrutinib)

Adult dose

1. Recommended dose The recommended dose of this drug is 200mg orally once daily. It should be taken at approximately the same time each day, if possible. Continue treatment until disease progression or unacceptable toxicity occurs. 2. Method of administration Take this drug with water at a consistent time each day, with or without food. Swallow the drug whole; do not break, crush, or chew it. 3. Missed dose If more than 12 hours have passed since the missed dose, skip it and take the next dose at the scheduled time. If vomiting occurs, do not take an additional dose; continue with the next scheduled dose. 4. Dose adjustment 1) Dose adjustment for adverse reactions Based on individual safety and tolerability, this drug may be temporarily withheld, the dose may be reduced, or treatment may be permanently discontinued (see Precautions for Use). If any of the adverse reactions listed in Table 1 occurs, temporarily withhold this drug until the reaction resolves to Grade 1 or baseline. Table 1. Dose adjustment of this drug for adverse reactions Adverse reactionsa Number of occurrences requiring dose adjustment Dose adjustment ․ Grade 3 or higher nonhematologic toxicityb ․ Grade 3 neutropenia accompanied by fever and/or infection ․ Grade 4 neutropenia lasting 7 days or longer ․ Grade 3 thrombocytopenia accompanied by bleeding ․ Grade 4 or higher thrombocytopenia 1 occurrence Temporarily withhold this drug until recovery to Grade 1 or baseline. When treatment is resumed, administer 200mg once daily (the original starting dose). 2 occurrences Temporarily withhold this drug until recovery to Grade 1 or baseline. When treatment is resumed, administer 100mg once daily. 3 occurrences Temporarily withhold this drug until recovery to Grade 1 or baseline. When treatment is resumed, administer 50mg once daily. 4 occurrences Permanently discontinue this drug. 2) Dose adjustment for drug interactions Do not use this drug concomitantly with a strong CYP3A inhibitor. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of this drug to 50mg. If the current dose is 50mg once daily, temporarily withhold treatment with this drug while the strong CYP3A inhibitor is being used. After discontinuing the strong CYP3A inhibitor, resume the dose of this drug that was taken before starting the inhibitor after 5 half-lives have elapsed. Do not use this drug concomitantly with a strong or moderate CYP3A inducer. If concomitant use with a moderate CYP3A inducer is unavoidable and the current dose of this drug is 200mg once daily, increase the dose to 300mg. If the current dose is 50mg or 100mg once daily, increase the dose by 50mg. 3) Patients with severe renal impairment For patients with severe renal impairment (eGFR 15-29ml/min), if the current dose is 200mg once daily, reduce the dose of this drug to 100mg once daily; if it is 100mg, reduce it to 50mg. If the current dose is 50mg once daily, discontinue this drug. Patients with end-stage renal disease receiving dialysis have not been studied.

This medication should not be used in patients who are allergic to this medication or any of its components. This medication contains lactose, so patients with congenital diseases that prevent lactose digestion should not take it. There is an increased risk of infection while taking this medication, so patients with symptoms of infection or those who are immunocompromised should be especially cautious. The risk of bleeding may be increased, so patients who have symptoms of bleeding or any blood abnormalities should be cautious while taking this medication. Blood cell counts may decrease, so regular blood tests are necessary, and in severe cases, the medication may need to be temporarily discontinued. Arrhythmias may occur, so patients with a history of heart disease should periodically monitor their heart condition. This medication may increase the risk of skin cancer, so patients should avoid sun exposure and monitor their skin condition. Serious side effects such as tumor lysis syndrome may rarely occur, so patients with a high tumor burden need special monitoring. Pregnant women should not take this medication as it may harm the fetus, and both men and women of childbearing potential must use effective contraception during treatment and for a period after. This medication should be used under the supervision of a specialist, as symptoms like fatigue and dizziness may occur, requiring caution when driving or operating machinery. This medication may interact with other drugs, so if other medications are being taken, it is essential to consult a doctor or pharmacist. The safety of this medication in children and adolescents under 18 years of age has not been established; therefore, use is not recommended. Elderly patients may have a higher risk of adverse reactions, so careful observation is required. Patients with impaired liver or kidney function may need dose adjustments, so they should consult healthcare professionals. When taking this medication, do not crush, chew, or break the tablet, and swallow it whole; in case of overdose, consult a healthcare provider immediately. This medication should be stored in a safe place out of reach of children.

• Fatigue
• neutropenia
• diarrhea
• contusion
• anemia
• thrombocytopenia
• pneumonia
• COVID‑19 pneumonia
• COVID‑19
• sepsis

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain its effectiveness and prevent degradation.

Appearance

A blue, round triangular film-coated tablet, embossed with "Lilly 50" on one side and "6902" on the other side.

Package unit

28 tablets/box [14 tablets/PTPX2], 56 tablets/box [14 tablets/PTPX4]