For Nurses and Pharmacists

SUPPORT & RESOURCES

FOR NURSES AND PHARMACISTS

Oncology Nurse Educators (ONEs)

AstraZeneca's team of ONEs works to ensure that health care providers have the relevant information and resources to support patient care.

How ONEs Can Help

ONEs are experienced oncology nurses available to support the clinical staff in your practice and deliver assistance based on your needs on-site, off-site, or virtually.

ONEs can:

  • Deliver disease-state education to nurses and other health care staff at your facility
  • Provide resources on the early recognition and management of adverse events associated with AstraZeneca therapies
  • Provide educational tools and resources designed for nurses, patients, and caregivers

To request a visit from an AstraZeneca Oncology Nurse Educator, send your request to the US Information Center at AstraZeneca by filling out the Request a Rep form below or by calling 1-800-236-9933. The information you submit will be governed by our Privacy Notice.

Helpful information for you and your patients

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Oral Adherence Checklist Download now

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Efficacy Information Download now

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Dosing Information Download now

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Safety Information Download now

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Patient Support Program Information Download now

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MCL Patient Identification Information Download now

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Clinical Management of CALQUENCE Therapy for Patients with MCL Download now

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Management of Patients with MCL on CALQUENCE Download now

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What You Need to Know About CALQUENCE Download now

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Starting on CALQUENCE Download now

REQUEST A REPRESENTATIVE

Have you talked to an AstraZeneca representative about CALQUENCE?

Patient Support

ENCOURAGE YOUR PATIENTS TO ENROLL TODAY FOR EDUCATION AND SUPPORT

CALQUENCE Cares offers your patients education and support throughout treatment with CALQUENCE.

  • Information about MCL and treatment with CALQUENCE
  • Trained nurses and pharmacists who are available to help at 1-800-236-9933
  • Regular mailings or emails with tips and information on managing treatment

Patients can register online at CALQUENCECares.com

HELPING PATIENTS ACCESS THE CARE THEY NEED

The AstraZeneca Access 360™ program provides personal support to connect patients to affordability programs and streamline access and reimbursement for CALQUENCE.

Access 360™ provides:

  • Assistance with understanding patient insurance coverage and pharmacy options
  • Prior authorization support
  • Claims and appeal process support
  • Eligibility requirements and enrollment assistance for specialty Patient Savings Programs
  • Referrals to patient assistance programs
  • Referrals to nurse assistance or educational support programs, if applicable

To learn more about the AstraZeneca Access 360™ program, please call 1-844-ASK-A360 (1-844-275-2360), Monday–Friday, 8 AM–8 PM ET, or visit MyAccess360.com.

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Affordability Brochure Download now

Access 360™ Enrollment Form

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Download form to enroll in Access 360™ and Affordability Support for Patients. This form can also be used for prescription information. Download now

CALQUENCE Distribution Information

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The latest list of Specialty Pharmacy Providers (SPPs) and Specialty Distributors (SDs) for CALQUENCE.Download now

Coding Resource

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Contains codes for CALQUENCE. Download now

Co-pay assistance may be available for eligible patients. Learn more.

This description of the AstraZeneca Access 360™ program is for informational purposes only. AstraZeneca Access 360™ does not file claims or appeals on behalf of health care professionals or patients and makes no representation or guarantee concerning reimbursement or coverage for any service or item.

CALQUENCE PATIENT SAVINGS PROGRAM FOR ELIGIBLE COMMERCIALLY INSURED PATIENTS

CALQUENCE Patient Savings Program

The goal of the CALQUENCE Patient Savings Program is to assist eligible patients with their out-of-pocket costs for CALQUENCE.

Most eligible patients will pay $0 per month and may have access to up to $26,000 per year to assist with CALQUENCE out-of-pocket costs. There are no income requirements to participate in the program.

For additional information, please visit astrazenecaspecialtysavings.com or call Access 360™ at 1-844-ASK-A360 (1-844-275-2360).

Eligibility Requirements:

  • Must be a resident of the United States or Puerto Rico
  • Patients must have commercial health insurance that covers medication costs for CALQUENCE, but not the full cost to the patient

Patients are ineligible if prescriptions are paid by any state or other federally funded programs, including, but not limited to, Medicare Part B, Medicare Part D, Medicaid, Medigap, VA or TRICARE, or where prohibited by law. Eligibility rules apply. Additional restrictions may apply.

The CALQUENCE Patient Savings Program covers the cost of the drug only, and does not cover costs for office visits, or any other associated costs.

Offer is invalid for claims and transactions more than 120 days from the date of service.

ADDITIONAL RESOURCES

Patient Profiles

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Explore profiles of patients with MCL who may be appropriate for treatment with CALQUENCE. Download now

VIDEO RESOURCES

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Patient Management

Patient Management for Nurses
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Patient Management for Prescribers
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Patient Selection

Efficacy and Safety
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Patient Selection
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MCL Disease Education

MCL Disease Education
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Physician Testimonials

Hear about Dr. Danilov’s experience prescribing CALQUENCE.
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Hear about Dr. Goy’s experience prescribing CALQUENCE.
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Hear about Dr. Graff’s experience prescribing CALQUENCE.
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IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) capsules

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 19% of 1029 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (11% of all patients, including pneumonia in 6%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 1.9% of all patients. Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jiroveci 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.

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) capsules

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 19% of 1029 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (11% of all patients, including pneumonia in 6%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 1.9% of all patients. Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jiroveci 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 with hematologic malignancies treated with CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE in clinical trials. Bleeding events of any grade, excluding bruising and petechiae, occurred in 22% of patients.

Use of antithrombotic agents concomitantly with CALQUENCE may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% 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 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients with hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia developed in 12% 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 12% of 1029 patients exposed to CALQUENCE in clinical trials. The most frequent second primary malignancy was skin cancer, reported in 6% of patients. Monitor patients for skin cancers and advise protection from sun exposure.

Atrial Fibrillation and Flutter

Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (e.g., palpitations, dizziness, syncope, dyspnea) and manage as appropriate.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) of any grade in patients with MCL were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

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 approximately every 12 hours.

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

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 at least 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 at least 2 weeks after the final dose.

Avoid administration of CALQUENCE in patients with severe hepatic impairment. Dose modifications are not required for patients with mild or moderate hepatic impairment.

INDICATION AND USAGE

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products by clicking here.

References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma: long-term efficacy and safety results from a phase 2 study. Poster presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-8, 2020 (Virtual Meeting). Abstract 2040.

References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Barf T, Covey T, Izumi R, et al. Acalabrutinib (ACP-196): a covalent Bruton tyrosine kinase inhibitor with a differentiated selectivity and in vivo potency profile. J Pharmacol Exp Ther. 2017;363(2):240-252. 3. Hendriks RW, Yuvaraj S, Kil LP. Targeting Bruton’s tyrosine kinase in B cell malignancies. Nat Rev Cancer. 2014;14(4):219-232.

References: 1. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659-667. 2. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 3. Wang M, Rule S, Zinzani PL, et al. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma. Leukemia. 2019;33(11):2762-2766. 4. Data on File, REF-43179. AstraZeneca Pharmaceuticals LP. 5. Wang M, Rule S, Zinzani PL, et al. Long-term follow-up of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma. Poster presented at: 60th Annual Meeting of the American Society of Hematology; December 1-4, 2018; San Diego, CA. 6. Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059-3068. 7. Data on File, REF-18540. AstraZeneca Pharmaceuticals LP.

References: 1. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659-667. 2. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 3. Wang M, Rule S, Zinzani PL, et al. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma. Leukemia. 2019;33(11):2762-2766. 4. Badillo M, Nava D, Dela Rosa M, Rodriguez S, Xu J, Wang M. Managing adverse events in patients with relapsed/refractory mantle cell lymphoma treated with acalabrutinib: clinical experience from the MD Anderson Center. Poster presentation at: Oncology Nursing Society 44th Annual Congress; April 11-14, 2019; Anaheim, CA. 5. Data on File, REF-43179. AstraZeneca Pharmaceuticals LP.

References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Barf T, Covey T, Izumi R, et al. Acalabrutinib (ACP-196): a covalent Bruton tyrosine kinase inhibitor with a differentiated selectivity and in vivo potency profile. J Pharmacol Exp Ther. 2017;363(2):240-252.