AstraZenica Calquence First Line of Treatment page 2 of 7 4C (near CLL-SLL) CALQUENCE is a registered trademark of the AstraZeneca group of companies. ©2026 AstraZeneca. All rights reserved. US-110425 3/26 1L=first-line; BTKi=Bruton tyrosine kinase inhibitor; CFU=criteria for use; CLL=chronic lymphocytic leukemia; PA=prior authorization; VA=Veterans Affairs. Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours. SPECIFIC POPULATIONS Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy. Advise female patients of reproductive potential to use effective contraception during treatment with CALQUENCE and for 1 week following the last dose of CALQUENCE. It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for 2 weeks after the last dose. Of patients that received AV in AMPLIFY, 33% (97/291) were ≥65 years, and 4.5% (13/291) were ≥75 years of age. In patients ≥65 years and <65 years of age, the fatal adverse reactions were 5% and 2.6%, respectively. Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. INDICATION AND USAGE CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Please see Brief Summary of full Prescribing Information on adjacent pages. You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. respectively. Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively. In patients with relapsed/refractory CLL in the ASCEND study exposed to CALQUENCE (n=154), serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection. Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients, dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection. Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE. In patients with previously untreated CLL in the AMPLIFY study who received CALQUENCE plus venetoclax (AV) (n=291), the most common adverse reactions (≥15%) of any grade were headache (35%), diarrhea (33%), musculoskeletal pain (25%), COVID-19 (21%), fatigue (18%), bruising (17%), rash (16%), and nausea (15%). The most common laboratory abnormalities (≥15%) of any grade in patients with previously untreated CLL who received AV were neutrophils decreased (78%), glucose increased (74%), lymphocytes decreased (56%), platelets decreased (43%), hemoglobin decreased (35%), calcium decreased (30%), ALT increased (26%), urate increased (25%), LDH increased (24%), potassium increased (22%), AST increased (22%), ALP increased (20%), glucose decreased (20%), creatinine increased (19%), and sodium increased (15%). Grade 4 laboratory abnormalities in >15% of patients treated with AV include absolute neutrophil count decreased (15%). Serious adverse reactions occurred in 25% of patients receiving AV. The most common serious adverse reactions (≥2%) were COVID-19 including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%). Fatal adverse events occurred in 3.4% of patients. The most common fatal adverse events included COVID-19 and COVID-19 pneumonia. Treatment discontinuation of CALQUENCE due to adverse reactions occurred in 8% of patients receiving AV. The most common adverse reaction (≥2%) leading to treatment discontinuation was COVID-19 pneumonia (2.1%). Dose reduction of CALQUENCE occurred in 6% of patients. Neutropenia was the only adverse reaction leading to dose reduction that occurred in ≥1% of patients. DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE. Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor. References: 1. U.S. Department of Veterans Affairs. VA Formulary Advisor. Accessed March 3, 2026. https://www.va.gov/formularyadvisor/drugs/4041649- ACALABRUTINIB-TAB 2. Express Scripts. TRICARE Formulary Search. Accessed March 2, 2026. https://www.express-scripts.com/frontend/open-enrollment/ tricare/fst/#/formularyPricing/results 3. CALQUENCE® (acalabrutinib) tablets [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. and ...the VA National Formulary and the TRICARE Uniform Formulary1,2 Individual costs and benefit design may vary by plan. Please consult with individual plans for specific information. TRICARE Available on the Uniform Formulary as a Tier 2 Preferred therapy for TRICARE members with CLL Does not require a PA when prescribed by a hematologist or an oncologist Scan QR code to access the CLL VA Oncology Clinical Pathway
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