处 方 药：是
原产地英文商品名：Calquence 100mg/Capsules 60Capsules/bottle
中文参考商品译名：Calquence胶囊 100毫克/粒 60粒/瓶
每瓶60粒：100毫克，硬胶囊，黄体，蓝色，用黑色墨水标记“ ACA 100毫克”
CALQUENCE(acalabrutinib) Granted US Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia US Food and Drug Administration(FDA) has granted Breakthrough Therapy Designation(BTD)for CALQUENCE(acalabrutinib)as a monotherapy treatment for adult patients with chronic lymphocytic leukemia(CLL), one of the most common types of leukemia in adults. IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE(acalabrutinib) HemorrhageSerious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy.Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis, have been reported in 2% of patients. Overall, bleeding events, including bruising and petechiae of any grade, occurred in approximately 50% of patients with hematological malignancies. The mechanism for the bleeding events is not well understood. CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding CALQUENCE for 3to 7days pre-and post-surgery, depending upon the type of surgery and the risk of bleeding. Infection Serious infections(bacterial, viral, orfungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy.Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus(HBV)reactivation and progressive multifocal leukoencephalopathy (PML)have occurred. Monitor patients for signs and symptoms of infection and treat as medically appropriate.Consider prophylaxis in patients who are at increased risk for opportunistic infections. Cytopenias In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia(23%), anemia(11%), and thrombocytopenia (8%), based on laboratory measurements. Monitor complete blood counts monthly during treatment. Second Primary Malignancies Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure. Atrial Fibrillation and Flutter In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients.Monitor for atrial fibrillation and atrial flutter and manage as appropriate. ADVERSE REACTIONS The most common adverse reactions(≥20%)of any grade were anemia,*thrombocytopenia,*headache (39%), neutropenia,*diarrhea(31%), fatigue(28%), myalgia (21%), and bruising(21%). Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils(36%)were based on laboratory measurements and adverse reactions.The most common Grade≥3non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea(3.2%). Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 4.8% of patients. DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid co-administration with a strong CYP3A inhibitor.If a strong CYP3A inhibitor will be used short-term, interrupt CALQUENCE. Moderate CYP3A Inhibitors: When CALQUENCE is co-administered with a moderate CYP3A inhibitor, reduce CALQUENCE dose to 100 mg once daily. Strong CYP3A Inducers: Avoid co-administration with a strong CYP3A inducer.If a strong CYP3A inducer cannot be avoided, increase the CALQUENCE dose to 200 mg twice daily. Gastric Acid Reducing Agents:If treatment with a gastric acid reducing agent is required, consider using an H2-receptor antagonist or an antacid. Take CALQUENCE 2 hours before taking an H2-receptor antagonist. Separate dosing with an antacid by at least 2 hours.Avoid co-administration with proton pump inhibitors. Due to the long-lasting effect of proton pump inhibitors, separation of doses may not eliminate the interaction with CALQUENCE. SPECIFIC POPULATIONS There is insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus. It is not known if CALQUENCE is present in human milk.Advise lactating women not to breastfeed while taking CALQUENCE and for at least 2 weeks after the final dose. About CALQUENCE CALQUENCE(acalabrutinib)was granted accelerated approval by the US Food and Drug Administration(FDA)in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. CALQUENCE is an inhibitor of Bruton tyrosine kinase (BTK).CALQUENCE binds covalently to BTK, thereby inhibiting its activity.In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.