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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 effects
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. indication
Acute myeloid leukemia, chronic lymphocytic leukemia / small lymphocytic lymphoma mantle cell lymphoma, relapsed / refractory
To assess the risk of tumor lysis syndrome (TLS); Prophylactic hydration and ANTIHYPERURICEMIC medications were administered prior to intravenous varices.
1. Newly diagnosed acute myeloid leukemia: ad-ults ≥ 75 years old or with comorbidities: oral:
Note: start azacitidine, decitabine, or low-dose cytarabine on day di1. The dose for varices depends on concomitant chemotherapy drugs. Leukocytes should be less than 25000 / mm3 before starting intravenous micelles; Cytoreduction may be necessary before treatment.
Di1 day: 100 mg once daily.
Di2 days: 200 mg daily.
Di3 days: 400 mg once daily. Venetoclax in combination with azacitidine or decitabine:
Day 4 and beyond: 400 mg once daily until disease progression or unacceptable toxicity.
Venetoclax was combined with low-dose cytarabine: day 4 and beyond: 600 mg daily until disease progression or unacceptable toxicity.
2. Chronic lymphocytic leukemia / small lymphocytic lymphoma: oral:
Di1 week: 20 mg once daily.
Di2 weeks: 50 mg once daily.
Di3 weeks: 100 mg once daily.
Week 4: 200 mg once daily.
Week 5: 400 mg once daily.
Venetoclax monotherapy: week 5 and thereafter: 400 mg once daily; Treatment was continued until disease progression or unacceptable toxicity occurred.
Venetoclax in combination with obinutuzumab:
Note: obinutuzumab was started on di 1 day of cycle 1; Venetoclax was initiated on day 22 of the di1 cycle according to the 5-week escalation schedule for chronic lymphocytic leukemia / small lymphocytic lymphoma described above; The increase will be complete by the end of cycle 2. Cycle 3 (di1 day and beyond): 400 mg once daily until the end of the Di12 cycle. Each cycle was 28 days.
Venetoclax in combination with rituximab: week 5, thereafter: 400 mg once daily; Variceal therapy was continued from di1 day of rituximab (di1 cycle) until disease progression or unacceptable toxicity within 24 months. Rituximab was initiated for 7 consecutive days after receiving venetoclax at a daily dose of 400 mg.
3. Relapsed / refractory mantle cell lymphoma: venetoclax monotherapy: oral
Di1week 20 mg daily,
Di2weeks of 50 mg daily,
Di3weeks 100 mg daily,
200 mg daily during week 4,
400 mg daily at week 5,
Week 6 and thereafter: 800 mg daily until disease progression or unacceptable toxicity or until allogeneic stem cell transplantation is performed.
Venetoclax in combination with ibrutinib:
Note: venetoclax is started after 4 weeks of ibrutinib monotherapy to reduce the risk of tumor lysis syndrome.
Initial dose: 20 mg daily for week 5, followed by 50 mg daily for week 6, then 100 mg daily for week 7, 200 mg daily for week 8, after week 9: 400 mg daily; Treatment was continued until disease progression or unacceptable toxicity occurred. If complete remission did not occur, the venetoclax dose could be increased to 800 mg once daily after 16 weeks di.
Myelosuppression: neutropenia, thrombocytopenia and anemia may occur. Type 3 and 4 neutropenia typically occur in chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL) patients treated with venetoclax, either as monotherapy or in combination with rituximab or obiitumab. Neutropenia has been reported with both monotherapy and combination therapy. When used in combination with azacitidine, decitabine, or low-dose cytarabine for acute myeloid leukemia (AML), nearly all patients experience worsening neutrophil baseline levels. Neutropenia may occur in subsequent cycles. Differences in CBC were monitored throughout treatment. Treatment interruption and / or dose reduction may be required. Consider antimicrobial agents and WBC growth factor support as clinically indicated.
Tumor lysis syndrome: tumor lysis syndrome (TLS; including death and renal failure requiring dialysis) occurs in patients with a high tumor burden when treated with venclax. Venetoclax may cause a rapid decrease in tumor volume, so there is a risk of TLS at the start of therapy and in the pretreatment phase of therapy live vaccination should not be performed before, during, or after venetoclax treatment until B-cell recovery. Vaccines may not be effective.
Adverse effects
Hypocalcemia (16% to 87%), hyperglycemia (67%), hyperkalemia (17% to 59%), increased serum aspartate aminotransferase (53%), decreased serum albumin (49%), hypophosphatemia (45%), diarrhea (43%), nausea (42%), hyponatremia (40%), upper respiratory tract infection (36%), fatigue (32%), musculoskeletal pain (29%), Hyperphosphatemia (14%), abdominal pain (18%), constipation (16%), vomiting (16%), mucositis (13%)
Tumor lysis syndrome (2 - to 3-week lifting phase: 13%; 5-week lifting phase: 2%), arthralgia (12%) cough (22%), pneumonia (14%), dyspnea (13%), lower respiratory tract infection (11%) edema (22%) fever (18%) rash (18%) headache (18%), dizziness (14%) hyperuricemia (10%)
Adverse effects grade 3-4: leukopenia (89%; grade 3 / 4: 42%; grade 4: 11%), neutropenia (50% to 87%; ≥ grade 3: 45% to 63%; grade 4: 33%), lymphopenia (11% to 74%; ≥ grade 3: 7% to 40%; grade 4: 9%), anemia (33% to 71%; ≥ grade 3: 18% to 26%), Thrombocytopenia (29% to 64%; ≥ grade 3: 20% to 31%; grade 4: 15%),