b'CALQUENCE (acalabrutinib): CALQUENCE is recommended for new patient starts on the VA National Formulary for CLL athe Sole BTKi on theNo other BTKi is included on formulary VA National Formulary and for the first-line treatment of CLLPreferred in VA Oncology Formulary statements or comparisons do not imply comparable efficacy, safety, or FDA-approved indications.This coverage determination applies to health plans associated with Department of Veterans Affairs, Indian Health Service, Bureau of Prisons, Clinical Pathways for First-Line Option 2 State Veterans Homes, and Federal Health Care Center. Treatment of CLL A next-generation BTKiCALQUENCE was evaluated in aPhase 3 study of a BTKi in patients with data at medianwith previously untreated CLL withand without obinutuzumab vs GClb. 26-year follow-up 1,b Learn more at calquencehcp.com Formulary statements or comparisons do not imply comparable efficacy, safety, or FDA-approved indications.a Subject to prior authorization with criteria for use (CFU).b At median 74.5-month follow-up (range: 0.0-89.0). BTKi=Bruton tyrosine kinase inhibitor; CLL=chronic lymphocytic leukemia; GClb=obinutuzumab + chlorambucil; VA=Veterans Affairs.INDICATION AND USAGE Cytopenias IMPORTANT SAFETY INFORMATION ABOUT CALQUENCEDRUG INTERACTIONSCALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), (acalabrutinib) tablets (contd) Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with treatment of adult patients with chronic lymphocytic leukemia (CLL) or small thrombocytopenia (7%), and lymphopenia (7%), developed in patients with ADVERSE REACTIONS (contd) a strong CYP3A inhibitor. If these inhibitors will be used short-term, lymphocytic lymphoma (SLL). hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia In patients with previously untreated CLL exposed to CALQUENCE, fatalinterrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE developed in 12% of patients. Monitor complete blood counts regularlyadverse reactions that occurred in the absence of disease progressionfor at least 24 hours, resume previous dosage of CALQUENCE.(acalabrutinib) tablets during treatment. Interrupt treatment, reduce the dose, or discontinueand with onset within 30 days of the last study treatment were reportedModerate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg Serious and Opportunistic Infections treatment as warranted. in 2% for each treatment arm, most often from infection. Serious adverseonce daily when co-administered with a moderate CYP3A inhibitor. Fatal and serious infections, including opportunistic infections, have Second Primary Malignancies reactions were reported in 39% of patients in the CALQUENCE plusStrong CYP3A Inducers: Avoid co-administration of CALQUENCE with occurred in patients with hematologic malignancies treated with Second primary malignancies, including skin cancers and other solid obinutuzumab arm and 32% in the CALQUENCE monotherapy arm,a strong CYP3A inducer. If co-administration is unavoidable, increase CALQUENCE. tumors, occurred in 12% of 1029 patients exposed to CALQUENCE in most often due to events of pneumonia (7% and 2.8%, respectively). the dosage of CALQUENCE to 200 mg approximately every 12 hours.Serious or Grade 3 or higher infections (bacterial, viral, or fungal) clinical trials.The most frequent second primary malignancy was skin Adverse reactions led to CALQUENCE dose reduction in 7% andSPECIFIC POPULATIONSoccurred in 19% of 1029 patients exposed to CALQUENCE in clinicalcancer, reported in 6% of patients.Monitor patients for skin cancers and4% of patients in the CALQUENCE plus obinutuzumab arm (N=178)Based on findings in animals, CALQUENCE may cause fetal harm and trials, most often due to respiratory tract infections (11% of all patients, advise protection from sun exposure. and CALQUENCE monotherapy arm (N=179), respectively. Adversedystocia when administered to a pregnant woman. There are no available including pneumonia in 6%).These infections predominantly occurredCardiac Arrhythmias events led to discontinuation in 11% and 10% of patients, respectively.data in pregnant women to inform the drug-associated risk. Advise Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) in the absence of Grade 3 or 4 neutropenia, with neutropenic infectionSerious cardiac arrhythmias have occurred in patients treated with occurred in 3.9% and 2.8% of patients in the CALQUENCE combinationpregnant women of the potential risk to a fetus. reported in 1.9% of all patients. Opportunistic infections in recipientsCALQUENCE. Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 arm and monotherapy arm, respectively. Pregnancy testing is recommended for females of reproductive potential of CALQUENCE have included, but are not limited to, hepatitis B viruspatients treated with CALQUENCE, with all grades of atrial fibrillation In patients with relapsed/refractory CLL exposed to CALQUENCE,prior to initiating CALQUENCE therapy. Advise female patients of reactivation, fungal pneumonia,Pneumocystis jirovecii pneumonia, or flutter reported in 4.1% of all patients. Grade 3 or higher ventricular serious adverse reactions occurred in 29% of patients. Serious adversereproductive potential to use effective contraception during treatment with Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal arrhythmia events were reported in 0.9% of patients.The risk may be reactions in 5% of patients who received CALQUENCE included lowerCALQUENCE and for 1 week following the last dose of CALQUENCE.leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased in patients with cardiac risk factors, hypertension, previous respiratory tract infection (6%). Fatal adverse reactions within 30 daysIt is not known if CALQUENCE is present in human milk. Advise lactating increased risk for opportunistic infections. Monitor patients for signs and arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, of the last dose of CALQUENCE occurred in 2.6% of patients, includingwomen not to breastfeed while taking CALQUENCE and for 2 weeks after symptoms of infection and treat promptly. palpitations, dizziness, syncope, dyspnea) and manage as appropriate. from second primary malignancies and infection. the last dose.Hemorrhage Hepatotoxicity, Including Drug-Induced Liver Injury Adverse reactions led to CALQUENCE dose reduction in 3.9% of patientsAvoid use of CALQUENCE in patients with severe hepatic impairment Fatal and serious hemorrhagic events have occurred in patients with Hepatotoxicity, including severe, life-threatening, and potentially fatal cases (N=154), dose interruptions in 34% of patients, most often due to(Child-Pugh class C). No dosage adjustment of CALQUENCE is hematologic malignancies treated with CALQUENCE. Major hemorrhage of drug-induced liver injury (DILI), has occurred in patients treated withrespiratory tract infections followed by neutropenia, and discontinuationrecommended in patients with mild (Child-Pugh class A) or moderate (serious or Grade 3 or higher bleeding or any central nervous system Bruton tyrosine kinase inhibitors, including CALQUENCE. in 10% of patients, most frequently due to second primary malignancies(Child-Pugh class B) hepatic impairment.bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in Evaluate bilirubin and transaminases at baseline and throughout treatment followed by infection. Increases in creatinine to 1.5 to 3 times ULNPlease see Brief Summary of full Prescribing Information on adjacent pages.0.1% of 1029 patients exposed to CALQUENCE in clinical trials. Bleeding with CALQUENCE. For patients who develop abnormal liver tests afteroccurred in 1.3% of patients who received CALQUENCE. You are encouraged to report the negative side effects of prescription events of any grade, excluding bruising and petechiae, occurred in 22%of patients. CALQUENCE, monitor more frequently for liver test abnormalities andReferences: 1.Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinibobinutuzumabdrugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.Use of antithrombotic agents concomitantly with CALQUENCE may clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE. 6-year follow-up of ELEVATE-TN. Abstract presented at: American Society of further increase the risk of hemorrhage. In clinical trials, major hemorrhage Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA. Abstract 636. occurred in 2.7% of patients taking CALQUENCE without antithrombotic ADVERSE REACTIONS 2. CALQUENCE (acalabrutinib) tablets [prescribing information]. Wilmington, DE:agents and 3.6% of patients taking CALQUENCE with antithromboticThe most common adverse reactions (30%) of any grade in patients with AstraZeneca Pharmaceuticals LP; 2024.agents. Consider the risks and benefits of antithrombotic agents when CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upperco-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 the platelets, and neutrophils were based on laboratory measurements CALQUENCE is a registered trademark of the AstraZeneca group of companies. risk of bleeding. and adverse reactions. 2024 AstraZeneca. All rights reserved. US-91257 6/24US-91257_US-91538 Calquence U.S. Medicine 2025 Directory of Federal Medical Treatment Facilities.indd 1 11/21/24 9:44AM US-91257_US-91538 Calquence U.S. Medicine 2025 Directory of Federal Medical Treatment Facilities.indd 2 11/21/24 9:44AM'