CALQUENCE® (acalabrutinib)
View Indication and Important Safety Information and full Prescribing Information.
CALQUENCE STRENGTH TO GO THE DISTANCE
* Median progression-free survival (PFS) was not reached with CALQUENCE + obinutuzumab vs 22.6 months (95% CI: 20‑28) with obinutuzumab + chlorambucil.1
IN PREVIOUSLY UNTREATED CLL
SAFETY AND TOLERABILITY CONSISTENT WITH THE ESTABLISHED PROFILE OF CALQUENCE
COMMON ADVERSE REACTIONS (≥15%, ANY GRADE) WITH CALQUENCE IN ELEVATE-TN*1
COMMON ADVERSE REACTIONS (≥15%, ANY GRADE) WITH CALQUENCE IN ELEVATE-TN
SELECT NON-HEMATOLOGIC LABORATORY ABNORMALITIES (≥15%, ANY GRADE), NEW OR WORSENING FROM BASELINE WITH CALQUENCE IN ELEVATE‑TN*1
SELECT NON-HEMATOLOGIC LABORATORY ABNORMALITIES (≥15%, ANY GRADE), NEW OR WORSENING FROM BASELINE WITH CALQUENCE IN ELEVATE-TN
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 + obinutuzumab and CALQUENCE monotherapy arms, respectively.1
EXPLORE THE SAFETY PROFILE OF CALQUENCE
MOST ADVERSE REACTIONS WERE GRADE 1 OR 2, WITH LOW RATES OF ATRIAL FIBRILLATION/FLUTTER AND HYPERTENSION
SELECT ADVERSE REACTIONS FOR CALQUENCE + OBINUTUZUMAB (n=178)ǁ1,2
SELECT ADVERSE REACTIONS FOR CALQUENCE + OBINUTUZUMAB (n=178)
Other clinically relevant adverse reactions (<15%, any grade) in recipients of CALQUENCE (CALQUENCE + obinutuzumab and as monotherapy) included1:
Neoplasms: second primary malignancy (10%), including non-melanoma skin cancer (5%)
Infection: herpesvirus infection (6%)
Cardiac disorders: atrial fibrillation or flutter (3.6%), hypertension (5%)
In the CALQUENCE plus obinutuzumab and CALQUENCE monotherapy arms, 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% of patients in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively).1
Study Design
ELEVATE-TN was a Phase 3, open-label, randomized, multicenter trial in patients with previously untreated CLL (N=535). Patients were randomized 1:1:1 to receive either CALQUENCE plus obinutuzumab (n=179), CALQUENCE monotherapy (n=179), or GClb (n=177). Patients in the CALQUENCE arms received 100 mg approximately every 12 hours until disease progression or unacceptable toxicity. The primary comparison was PFS between the CALQUENCE plus obinutuzumab and GClb arms. PFS for CALQUENCE monotherapy vs GClb was a secondary endpoint in the study.1,2
* The median duration of exposure to CALQUENCE in the CALQUENCE + obinutuzumab and CALQUENCE monotherapy arms was 27.7 months (range: 0.3 to 40 months).1
Includes multiple adverse drug reaction terms (see full Prescribing Information).1
Includes 3 fatal cases in the CALQUENCE + obinutuzumab arm, 3 fatal cases in the CALQUENCE monotherapy arm, and 1 fatal case in the GClb arm.1
§ Excludes electrolytes.1
|| Infusion-related reactions were reported in 14% of patients in the CALQUENCE + obinutuzumab arm and 40% of patients in the GClb arm.2
ALT=alanine aminotransferase; AST=aspartate aminotransferase; CI=confidence interval; CLL=chronic lymphocytic leukemia; GClb=obinutuzumab + chlorambucil; HR=hazard ratio.
LEARN MORE ABOUT CALQUENCE
INDICATION AND USAGE
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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.
Please see full Prescribing Information, including Patient Information.
For more information on CALQUENCE, visit CALQUENCEhcp.com.
You may report side effects related to AstraZeneca products by clicking here.
References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Sharman ELEVATE TN pub - Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment‑naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial [published correction appears in Lancet. 2020;395(10238):1694]. Lancet. 2020;395(10232):1278‑1291.
This product information is intended for US health care professionals only.
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©2020 AstraZeneca. All rights reserved. US-39017 Last Updated 7/20
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