Formulation and Specifications: Capsules: 140mg
Indications:
1. Monotherapy is indicated for the treatment of patients with set cell lymphoma (MCL) who have received at least one prior therapy.
2. Monotherapy for the treatment of patients with primary and relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma.
3. monotherapy or in combination with rituximab for the treatment of primary and relapsed Walden’s macroglobulinemia.
Key points for rational drug use:
1. Before ibrutinib is used for CLL treatment, a rigorous clinical evaluation should be performed, and if the patient has clear del (17p), BTK inhibitor therapy is selected.
2. The diagnosis of condylomatous lymphoma or chronic lymphocytic leukemia or Warf’s macroglobulinemia must be clearly established before dosing, and the therapeutic dose varies depending on the diagnosis.
3. Baseline evaluation should be done before treatment and treatment response and toxicity should be monitored regularly during treatment in accordance with relevant disease guidelines.
4. The recommended dose for the treatment of MCL is 560 mg once daily until disease progression or intolerable toxicity occurs; the recommended dose for the treatment of CLL/SLL and Warf’s macroglobulinemia is 420 mg once daily until disease progression or intolerable toxicity occurs.
5. The recommended dose for patients with mild hepatic impairment is 140 mg per day; avoid in patients with moderate to severe hepatic impairment.
6. Administer orally once daily at approximately the same time of day. The entire capsule should be delivered with water. Do not open, break or chew the capsule. If you do not take this product at the scheduled time, take it as soon as possible on the same day and continue to take it at the normal scheduled time the next day. Do not take additional doses of this product to make up for missed doses.
7. Treatment should be interrupted in the event of any Grade ≥3 non-hematologic toxicity, Grade ≥3 neutropenia with infection or fever, or Grade 4 hematologic toxicity. Treatment may be restarted at the starting dose when symptoms of toxicity subside to Grade 1 or baseline levels (recovery). If this toxicity reoccurs, the dose should be reduced by 140 mg and a further reduction of 140 mg may be considered if necessary. if the toxicity persists or reoccurs after two dose reductions, it should be discontinued.
8. The most frequent adverse reactions (≥20%) in patients with MCL treated with this drug are diarrhea, bleeding (e.g., bruising), fatigue, skeletal muscle pain, nausea, upper respiratory tract infection, cough, and rash. The most common grade 3 or 4 adverse reactions (≥5%) were neutropenia, thrombocytopenia, infectious pneumonia, and anemia. The most frequent adverse reactions (≥20%) in patients with CLL or SLL treated with this drug were neutropenia, thrombocytopenia, anemia, diarrhea, skeletal muscle pain, nausea, rash, bruising, fatigue, fever, and bleeding.