匹妥布替尼片pirtobrutinib 100mg

For adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies, including a Bruton's tyrosine kinase (BTK) inhibitor. For adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies, including a BTK inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

Recommended Dose The recommended dose of pirtobrutinib is 200 mg orally once daily, until disease progression or unacceptable toxicity occurs. Swallow the tablets whole with water. Do not cut, crush, or chew the tablets. Take pirtobrutinib at approximately the same time every day, with or without food. If a dose of pirtobrutinib is missed by more than 12 hours, do not make up the missed dose and take the next dose as scheduled. Dose Adjustment for Adverse Reactions Recommended dose adjustments for pirtobrutinib adverse reactions are shown in Table 1. Table 1: Dose Adjustments for Pirtobrutinib Adverse Reactions (Initial dose: 200 mg once daily) Situations Requiring Dose Adjustment Dose Modification Grade 3 or higher non-hematologic toxicity^a Absolute neutrophil count (ANC) < 1×10⁹/L and ≥ 0.5×10⁹/L with fever and/or infection ANC < 0.5×10⁹/L lasting for 7 days or longer Platelet count < 50×10⁹/L and ≥ 25×10⁹/L with bleeding Platelet count < 25×10⁹/L First occurrence: Withhold pirtobrutinib until recovery to Grade 1 or baseline; then restart at the initial dose (200 mg once daily). Second occurrence: Withhold pirtobrutinib until recovery to Grade 1 or baseline; then restart at 100 mg once daily. Third occurrence: Withhold pirtobrutinib until recovery to Grade 1 or baseline; then restart at 50 mg once daily. Fourth occurrence: Discontinue pirtobrutinib permanently. ^a For Grade 4 non-hematologic toxicity, evaluate the benefit-risk profile before resuming treatment at the same dose.

Infections: Monitor for signs and symptoms of infection, and conduct timely evaluation and treatment. Hemorrhage: Monitor for bleeding and manage appropriately. Cytopenias: Monitor complete blood counts during treatment. Arrhythmias: Monitor for symptoms of arrhythmias and manage appropriately. Second Primary Malignancies: Other malignancies have occurred, including skin cancer and other tumor types. Conduct monitoring and advise patients to take sun protection measures. Hepatic Toxicity, Including Drug-induced Liver Injury: Monitor liver function throughout the course of treatment. Embryo-Fetal Toxicity: May cause fetal harm. Inform females of reproductive potential about the potential risk to the fetus and advise them to use effective contraceptive measures.

The most common adverse reactions (incidence ≥ 20%) are fatigue, musculoskeletal pain, diarrhea, COVID-19 infection, bruising, and cough.

30 tablets per bottle.

Store at room temperature below 30℃. Keep out of the reach of children.