Yinokai Orelabrutinib Tablets

1. Indications and Usage
Mantle Cell Lymphoma: Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
CLL/SLL: Indicated for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) who have received at least one prior therapy.
2. Dosage and Administration
Recommended Dose: The recommended dosage is 150 mg (three 50 mg tablets) taken orally once daily.
Administration: Tablets should be swallowed whole with water and cannot be chewed, crushed, or dissolved. They can be taken before or after meals.
Dose Modifications: Dosage interruptions or reductions (to 100 mg, 50 mg, or 25 mg) are required for specific adverse reactions, particularly hematologic toxicity and bleeding.
3. Mechanism of Action
BTK Inhibition: Orelabrutinib is a small-molecule inhibitor that selectively targets Bruton’s tyrosine kinase (BTK).
Pathway Blockade: By binding to BTK, it inhibits the B-cell receptor signaling pathway, thereby blocking the proliferation and survival of malignant B cells.
4. Safety and Warnings
Hemorrhage: Fatal and serious bleeding events have been reported. Patients with severe active bleeding should not use this drug.
Infection: Increased risk of infections, including upper respiratory tract infections and pneumonia, may occur during long-term treatment.
Cytopenias: Neutropenia, thrombocytopenia, and anemia are common.
Hepatitis B Reactivation: Reactivation of the Hepatitis B virus has been observed.
Second Primary Malignancies: New malignancies, including acute myeloid leukemia, have been reported.
Hypertension: Increases in blood pressure have been observed during treatment.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include neutropenia, thrombocytopenia, diarrhea, rash, pneumonia, and musculoskeletal pain.
Clinical Research: Clinical trials have demonstrated that orelabrutinib provides high response rates and durable remission in patients with relapsed/refractory MCL and CLL/SLL.
6. Drug Interactions
CYP3A4 Inhibitors: Strong or moderate CYP3A4 inhibitors may increase orelabrutinib plasma concentrations and should be avoided.
CYP3A4 Inducers: Strong or moderate CYP3A4 inducers may decrease efficacy and should be avoided.
Surgery: The drug should be discontinued at least 3 days prior to elective surgery with significant bleeding risk.
7. Pharmaceutical Information
Composition: The active ingredient is orelabrutinib.
Appearance: Available as film-coated tablets.
Storage: Store at controlled room temperature and protect from moisture.