b'CALQUENCE (acalabrutinib):the Sole BTKi on the VA National Formulary and Preferred in VA Oncology Clinical Pathways for First-Line Treatment of CLLFormulary statements or comparisons do not imply comparable efficacy, safety, or FDA-approved indications.INDICATION AND USAGE CytopeniasCALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for theGrade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), treatment of adult patients with chronic lymphocytic leukemia (CLL) or smallthrombocytopenia (7%), and lymphopenia (7%), developed in patients with lymphocytic lymphoma (SLL). hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia IMPORTANT SAFETY INFORMATION ABOUT CALQUENCEdeveloped in 12% of patients. Monitor complete blood counts regularly (acalabrutinib) tablets during treatment. Interrupt treatment, reduce the dose, or discontinue Serious and Opportunistic Infections treatment as warranted.Fatal and serious infections, including opportunistic infections, haveSecond Primary Malignanciesoccurred in patients with hematologic malignancies treated withSecond primary malignancies, including skin cancers and other solid CALQUENCE.tumors, occurred in 12% of 1029 patients exposed to CALQUENCE in Serious or Grade 3 or higher infections (bacterial, viral, or fungal)clinical trials. The most frequent second primary malignancy was skin occurred in 19% of 1029 patients exposed to CALQUENCE in clinicalcancer, reported in 6% of patients.Monitor patients for skin cancers and trials, most often due to respiratory tract infections (11% of all patients,advise protection from sun exposure. including pneumonia in 6%). These infections predominantly occurredCardiac Arrhythmiasin the absence of Grade 3 or 4 neutropenia, with neutropenic infectionSerious cardiac arrhythmias have occurred in patients treated with reported in 1.9% of all patients. Opportunistic infections in recipientsCALQUENCE. Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 of CALQUENCE have included, but are not limited to, hepatitis B viruspatients treated with CALQUENCE, with all grades of atrial fibrillation reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia,or flutter reported in 4.1% of all patients. Grade 3 or higher ventricular Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocalarrhythmia events were reported in 0.9% of patients. The risk may be leukoencephalopathy (PML). Consider prophylaxis in patients who are atincreased in patients with cardiac risk factors, hypertension, previous increased risk for opportunistic infections. Monitor patients for signs andarrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, symptoms of infection and treat promptly. palpitations, dizziness, syncope, dyspnea) and manage as appropriate.Hemorrhage Hepatotoxicity, Including Drug-Induced Liver InjuryFatal and serious hemorrhagic events have occurred in patients withHepatotoxicity, including severe, life-threatening, and potentially fatal cases hematologic malignancies treated with CALQUENCE. Major hemorrhageof drug-induced liver injury (DILI), has occurred in patients treated with (serious or Grade 3 or higher bleeding or any central nervous systemBruton tyrosine kinase inhibitors, including CALQUENCE.bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring inEvaluate bilirubin and transaminases at baseline and throughout treatment 0.1% of 1029 patients exposed to CALQUENCE in clinical trials. Bleedingwith CALQUENCE. For patients who develop abnormal liver tests after events of any grade, excluding bruising and petechiae, occurred in 22%CALQUENCE, monitor more frequently for liver test abnormalities and of patients. clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Use of antithrombotic agents concomitantly with CALQUENCE mayCALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.further increase the risk of hemorrhage. In clinical trials, major hemorrhageADVERSE REACTIONSoccurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithromboticThe most common adverse reactions (30%) of any grade in patients with agents. Consider the risks and benefits of antithrombotic agents whenCLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper co-administered with CALQUENCE. Monitor patients for signs of bleeding. respiratory tract infection, and diarrhea. Consider the benefit-risk of withholding CALQUENCE for 3-7 days*Treatment-emergent decreases (all grades) of hemoglobin, pre- and post-surgery depending upon the type of surgery and theplatelets, and neutrophils were based on laboratory measurements risk of bleeding. and adverse reactions.US-91257_US-91538 Calquence U.S. Medicine 2025 Directory of Federal Medical Treatment Facilities.indd 1 11/21/24 9:44AM'