AstraZenica
Calquence
First Line of 
Treatment
page 1 of 7
4C
(near CLL-SLL)
FOR THE FIRST-LINE TREATMENT OF CLL
both
CALQUENCE: The only BTKi available on both
US DEPARTMENT OF VETERANS AFFAIRS 
The sole BTKi for the 1L treatment of CLL on the VA National Formulary (with PA/CFU)a
Recommended for CLL new patient starts and preferred in VA Oncology Clinical Pathwaysa
Formulary statements or comparisons do not imply comparable efficacy, safety, or FDA-approved indications.
aSubject to prior authorization with criteria for use. bDesigned to be completed in fourteen 28-day cycles (2 cycles of CALQUENCE monotherapy followed 
by 12 cycles of CALQUENCE + venetoclax, starting venetoclax using a 5-week ramp-up as per dose schedule), unless disease progression or unacceptable 
toxicity warrants earlier discontinuation. cCALQUENCE monotherapy given until disease progression or unacceptable toxicity.
IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® 
(acalabrutinib) tablets
Serious and Opportunistic Infections
Fatal and serious infections, including opportunistic infections, have occurred in 
patients with hematologic malignancies treated with CALQUENCE. 
Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 29% 
of 2,055 patients exposed to CALQUENCE in clinical trials, most often due to 
respiratory tract infections (18% of all patients, including pneumonia in 14%). These 
infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, 
with neutropenic infection reported in 8% of all patients. Opportunistic infections 
in recipients of CALQUENCE have included, but are not limited to, hepatitis 
B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, 
Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal 
leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased 
risk for opportunistic infections. Monitor patients for signs and symptoms of 
infection and treat promptly.
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients treated with 
CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or 
any central nervous system bleeding) occurred in 4.7% of patients, with fatal 
hemorrhage occurring in 0.1% of 2,055 patients exposed to CALQUENCE in 
clinical trials. Bleeding events of any grade, excluding bruising and petechiae, 
occurred in 39% of patients.
Use of antithrombotic agents concomitantly with CALQUENCE may further 
increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 
5% of patients taking CALQUENCE without antithrombotic agents and 3.2% of 
patients taking CALQUENCE with antithrombotic agents. Consider the risks and 
benefits of antithrombotic agents when co-administered with CALQUENCE. 
Monitor patients for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3 to 7 days pre- and post-
surgery depending upon the type of surgery and the risk of bleeding.
Cytopenias
CALQUENCE can cause Grade 3 or 4 cytopenias. Grade 3 or 4 cytopenias included 
absolute neutrophil count decreased (28%), absolute lymphocyte count decreased 
(10%), hemoglobin decreased (9%), and platelets decreased (9%) in 1,758 patients 
treated with CALQUENCE alone and in combination with obinutuzumab or 
venetoclax; Grade 4 neutropenia developed in 14% of patients. 
Monitor complete blood counts regularly during treatment. Interrupt treatment, 
reduce the dose, or discontinue treatment as warranted.
Second Primary Malignancies
Second primary malignancies, including skin cancers and other solid tumors, 
occurred in 16% of 2,055 patients exposed to CALQUENCE in clinical trials. The 
most frequent second primary malignancy was non-melanoma skin cancer, reported 
in 9% of patients, followed by other solid tumors in 8% (including melanoma, 
lung cancer, gastrointestinal cancers, and genitourinary cancers) and hematologic 
malignancies (1.1%). Fatal second primary malignancies occurred in 0.8% of 
patients. Monitor patients for the development of second cancers and advise 
protection from sun exposure.
Cardiac Arrhythmias
Fatal and serious cardiac arrhythmias have occurred in patients treated with 
CALQUENCE. Grade 3 or 4 atrial fibrillation or flutter was reported in 2.2% of 2,055 
patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter 
reported in 7% of all patients. Grade 3 or higher ventricular arrhythmia events were 
reported in 0.5% of patients, including fatal cases in 0.3% of all patients. The risk 
of arrhythmias may be increased in patients with cardiac risk factors, hypertension, 
previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, 
palpitations, dizziness, syncope, dyspnea) and manage as appropriate.
Hepatotoxicity, Including Drug-Induced Liver Injury
Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of 
drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine 
kinase inhibitors, including CALQUENCE.
Evaluate bilirubin and transaminases at baseline and throughout treatment with 
CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, 
monitor more frequently for liver test abnormalities and clinical signs and symptoms 
of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of 
DILI, discontinue CALQUENCE.
ADVERSE REACTIONS
Chronic Lymphocytic Leukemia
The most common adverse reactions (≥30%) of any grade in patients with CLL 
in the ELEVATE-TN and ASCEND studies exposed to CALQUENCE (n=511) were 
anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract 
infection, and diarrhea.
    * Treatment-emergent decreases (all grades) of hemoglobin, platelets, and 
neutrophils were based on laboratory measurements and adverse reactions.
In patients with previously untreated CLL in the ELEVATE-TN study exposed to 
CALQUENCE (n=357), fatal adverse reactions that occurred in the absence of 
disease progression and with onset within 30 days of the last study treatment were 
reported in 2% for each treatment arm, most often from infection. Serious adverse 
reactions were reported in 39% (69/178) of patients in the CALQUENCE plus 
obinutuzumab arm (n=178) and 32% (57/179) in the CALQUENCE monotherapy 
arm (n=179), most often due to events of pneumonia (2.8% to 7%).
Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in 
the CALQUENCE plus obinutuzumab arm and CALQUENCE monotherapy arm, 
respectively. Adverse reactions led to discontinuation in 11% and 10% of patients, 
The first and only BTKi offering 
the choice of all-oral fixed durationb
and continuousc regimens in 1L CLL3
Learn more at
   calquencehcp.com
 ...

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