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Clinical Trial Data in relapsed/refractory MCL
 
 
Learn about a treatment option for your patients
CALQUENCE® (acalabrutinib) 100 mg capsules
View Prescribing Information, Important Safety Information
 
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
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.
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
In a Phase 2, open-label, single-arm trial (LY-004) of acalabrutinib 100 mg twice daily in 124 patients*†1,2:
CALQUENCE was administered orally at 100 mg twice daily until disease progression or unacceptable toxicity
 
80% ORR and 40% CR were achieved with CALQUENCE
• 80% [95% CI: 72, 87] ORR*†1
• 40% [95% CI: 31, 49] CR*†1
 
* LY-004 was a Phase 2, open-label trial of CALQUENCE monotherapy in adult patients with MCL who had received ≥1 prior therapy (N=124). The major efficacy outcome was overall response rate and the median follow-up was 15.2 months.1
Independent Review Committee-assessed per 2014 Lugano Classification response criteria for non-Hodgkin lymphoma (NHL).1
 

Median DoR not reached at a median follow-up of 15.2 months1

Duration of response in relapsed/refractory MCL
 
Median follow-up was 15.2 months (range: 0.3 to 23.7 months)1,3
Please see full Important Safety Information below.
  Learn more at calquence.com/physician  
 
 
 
SELECT IMPORTANT SAFETY INFORMATION
Hemorrhage
Serious hemorrhagic events, including fatal events, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher bleeding events, including gastrointestinal, intracranial, and epistaxis, have been reported in 2% of patients. Overall, bleeding events, including bruising and petechiae of any grade, occurred in approximately 50% of patients with hematological malignancies.
The mechanism for the bleeding events is not well understood.
CALQUENCE may further increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored 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.
CALQUENCE® (acalabrutinib) 100 mg capsules
 
CALQUENCE:
Proven safety profile
 
The most common (≥20%) adverse drug reactions were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising1
Warnings and precautions include hemorrhage, infections, cytopenias, second primary malignancies, and atrial fibrillation/flutter1
Twice-daily dosing1
 
CALQUENCE maintained median steady state BTK occupancy of ≥95% in peripheral blood over 12 hours, resulting in inactivation of BTK throughout the recommended dosing interval1
Unique support programs help you and your patients every step of the way
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
IMPORTANT SAFETY INFORMATION (Cont'd)
Infection
Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, have occurred in the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy. Grade 3 or higher infections occurred in 18% of these patients. The most frequently reported Grade 3 or 4 infection was pneumonia. Infections due to hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have occurred.
Monitor patients for signs and symptoms of infection and treat as medically appropriate. Consider prophylaxis in patients who are at increased risk for opportunistic infections.
Cytopenias
In the combined safety database of 612 patients with hematologic malignancies, patients treated with CALQUENCE monotherapy experienced Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (11%), and thrombocytopenia (8%), based on laboratory measurements. Monitor complete blood counts monthly during treatment.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinomas, have occurred in 11% of patients with hematologic malignancies treated with CALQUENCE monotherapy in the combined safety database of 612 patients. The most frequent second primary malignancy was skin cancer, reported in 7% of patients. Advise protection from sun exposure.
Atrial Fibrillation and Flutter
In the combined safety database of 612 patients with hematologic malignancies treated with CALQUENCE monotherapy, atrial fibrillation and atrial flutter of any grade occurred in 3% of patients, and Grade 3 in 1% of patients. Monitor for atrial fibrillation and atrial flutter and manage as appropriate.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) of any grade were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%).
*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.
The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).
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 twice daily.
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
There is insufficient clinical data on CALQUENCE use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.
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.
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.
You may report side effects related to AstraZeneca products by clicking here.
CR=complete response; DoR=duration of response; ORR=overall response rate; PR=partial response.
References: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017. 2. 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. 3. Data on file,
REF-18540. AstraZeneca Pharmaceuticals LP.
 
CALQUENCE® (acalabrutinib) 100 mg capsules
 
Prescribing Information CALQUENCE.com/physician
 
 
 
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©2018 AstraZeneca. All rights reserved. US-20491 Last Updated 5/18 AstraZeneca logo
 
 

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