Note: before purchasing and taking medicines, a hospital genetic test report and a doctor's diagnosis report or certificate must be produced
Ibrutinib is a kinase inhibitor indicated for the treatment of patients:
(1) Had received at least 1 prior therapy for mantle cell lymphoma (MCL) patients;
(2) Had received at least 1 prior therapy for chronic lymphocytic leukemia (CLL).
These indications were based on the overall remission rate. Survival or disease-related symptom improvement has not been established.
MCL: 560 mg orally once daily (4 140 mg capsules once daily)
CLL: 420 mg orally once daily (3 140 mg capsules once daily)
Oral capsule with one glass of water. Do not open or chew the capsule.
(1) Bleeding: 5% of patients with MCL had grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). In summary, bleeding events including any grade bruising occurred in 48% of patients with MCL treated with 560 mg daily. The benefit risk profile of ibrutinib needs to be considered in patients on antiplatelet or anticoagulant therapy; Ibrutinib was stopped at least 3-7 days before surgery depending on the type of surgery and bleeding risk.
(2) Infection: surveillance of patients with fever and infection and prompt evaluation.
(3) Myelosuppression: Grade 3 or 4 pancytopenia on therapy occurred in 41% of patients. These included neutropenia (29%), thrombocytopenia (17%), and anemia (9%). Complete blood counts were checked monthly.
(4) Nephrotoxicity: fatal and severe cases have occurred while on therapy with ibrutinib. Treatment emergent increases in creatinine levels to 1.5 times the upper limit of normal occurred in 67% of patients and to 1.5 to 3 times the upper limit of normal in 9% of patients. Monitor renal function and maintain hydration.
(5) Second primary malignancies: MCL patients treated with ibrutinib had previously developed other malignancies (5%), including skin cancer (4%), and other carcinomas (1%).
(6) Embryo fetal toxicity: a fetal hazard. Counsel women about the potential risks to the fetus avoid taking medicines when pregnant.
Adverse drug reactions included: hemorrhage, infection, myelosuppression, nephrotoxicity, second primary malignancy, embryofetal toxicity. Common adverse events (≥ 20%) in patients with MCL were thrombocytopenia, diarrhoea, neutropenia, anaemia, fatigue, musculoskeletal pain, peripheral oedema, upper respiratory tract infection, nausea, bruising, dyspnoea, constipation, rash, abdominal pain, vomiting, and reduced appetite. Common adverse reactions (≥ 20%) in patients with CLL were thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory tract infection, fatigue, musculoskeletal pain, rash, pyrexia, constipation, peripheral edema, arthralgia, nausea, stomatitis, sinusitis, and vertigo. Note: adverse reactions with respect to the drug are detailed in the [warnings and precautions] section of the specification.