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CALQUENCE® (acalabrutinib) 100 mg capsules
View Prescribing Information, Important Safety Information
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.
CALQUENCE® (acalabrutinib) 100mg capsules
Continuous inhibition of BTK is maintained with 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 interval.1
If a dose is missed by more than 3 hours, it should be skipped and the next dose should be taken at its regularly scheduled time. Extra capsules should not be taken to make up for a missed dose
Avoid co-administration with proton pump inhibitors. Stagger dosing with H2-receptor antagonists and antacids
Dose modifications are recommended for adverse reactions
Grade ≥3. Please see the full Prescribing Information for guidance
Please see Important Safety Information below.
SELECT 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.
Strong efficacy proven over time in patients with relapsed/refractory MCL
LY-004 Trial: Phase 2, open-label, single-arm, multicenter trial enrolled 124 patients (≥18 years) with MCL who had received ≥1 prior therapy. Patients received CALQUENCE 100 mg BID until disease progression or unacceptable toxicity. The primary endpoint was ORR; secondary endpoints were DoR, PFS, and OS.1,2
Initial data analysis was based on efficacy and safety endpoints that occurred from March 12, 2015, through approximately 14 months after the last subject was enrolled.2
The 24‑month update analysis was based on the cumulative efficacy and safety endpoints that occurred from March 12, 2015, until data cutoff on February 12, 2018 (24‑month update).3
* Independent Review Committee-assessed per 2014 Lugano Classification response criteria for NHL.1
Investigator-assessed response rates were ORR: 81%; CR: 40%; PR: 41%.1
Investigator-assessed per 2014 Lugano Classification response criteria for NHL.3
§ Median follow-up for DoR was 26.3 months (range: 0.3 to 35.1 months).3
|| Duration of response was measured in the 100 subjects who achieved a CR or PR.3
CR=complete response; DoR=duration of response; ORR=overall response rate; OS=overall survival;
PFS=progression-free survival; PR=partial response.
Demonstrated safety profile from initial data analysis
Warnings and precautions include hemorrhage, infections, cytopenias, second primary malignancies, and atrial fibrillation/flutter1
The most common adverse drug reactions (≥20%) were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising1
Safety profile from 24-month update analysis consistent with initial data analysis
Most common treatment-emergent adverse events ≥20%: headache (37.9%),
diarrhea (36.3%), fatigue (28.2%), myalgia (21%), and cough (21.8%)3
If you would like to learn more about CALQUENCE, including the 24-month update analysis recently presented, please visit CALQUENCE.com/physician. You can also request a visit from a representative if you would like to discuss CALQUENCE in person.
SELECT 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 complete Prescribing Information including Patient Information.
You may report side effects related to AstraZeneca products by clicking here.
For more information about CALQUENCE, you may visit www.CALQUENCE.com/physician.
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-43179. AstraZeneca Pharmaceuticals LP.
Prescribing Information CALQUENCE.com/physician
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
©2019 AstraZeneca. All rights reserved. US-28421 Last Updated 4/19 AstraZeneca Logo

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