Patient Support

SUPPORT & RESOURCES

CALQUENCE: A STRONG FOCUS ON PATIENT EDUCATION

taking-calquence

CALQUENCECares™ offers your patients education and support throughout treatment with CALQUENCE

Encourage your patients to enroll for personalized education and support, including:

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

Patients can register online at CALQUENCECaresCLL.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.

Access 360 Enrollment Form

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Download the 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

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

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 www.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.

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Affordability Brochure Download now

How to order

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Click the link below for information on how to make an order. Download now

Additional Resources

Patient Profiles

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Ellen: Previously untreated patient with high-risk features Download now

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Sam: Previously untreated patient with comorbidities Download now

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Frank: Relapsed/refractory patient Coming soon

Dosing and Administration

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Dosing GuideComing soon

Request a Representative

Have you talked to an AstraZeneca representative about CALQUENCE? Click here to request a visit from a representative.

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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.

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 (≥ 30%) of any grade in patients with CLL 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 exposed to CALQUENCE, 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% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively).

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

In patients with relapsed/refractory CLL exposed to CALQUENCE, 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 (N=154), dosage 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 1.5 to 3 times the upper limit of normal occurred in 1.3% of patients who received CALQUENCE.

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 indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Please see full Prescribing Information, including Patient Information.

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

Reference: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Data on File, REF-64711. AstraZeneca Pharmaceuticals LP. 3. Elevate CLL TN: study of obinutuzumab + chlorambucil, acalabrutinib (ACP-196) + obinutuzumab, and acalabrutinib in subjects with previously untreated CLL. ClinicalTrials.gov identifier: NCT02475681. https://clinicaltrials.gov/ct2/show/NCT02475681. Updated October 14, 2019. Accessed November 14, 2019. 4. Sharman JP, Banerji V, Fogliatto LM, et al. ELEVATE TN: phase 3 study of acalabrutinib combined with obinutuzumab (O) or alone vs O plus chlorambucil (Clb) in patients (pts) with treatment-naive chronic lymphocytic leukemia (CLL). Abstract for American Society of Hematology Annual Meeting; December 7-10, 2019; Orlando, FL. 5. A study of acalabrutinib vs investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab in R/R CLL. ClinicalTrials.gov identifier: NCT02970318. https://clinicaltrials.gov/ct2/show/NCT02970318. Updated August 16, 2019. Accessed November 14, 2019. 6. Ghia P, Pluta A, Watch M, et al. ASCEND phase 3 study of acalabrutinib vs investigator's choice of rituximab plus idelalisib (IDR) or bendamustine (BR) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at: 24th European Hematology Society Congress; June 13-16, 2019; Amsterdam, the Netherlands.

References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Data on File, REF-64711. AstraZeneca Pharmaceuticals LP.

Reference: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

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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.