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A BTKi for adult patients with MCL after one prior therapy 1
CALQUENCE
GO STRONG
FOCUSED ON EFFICACY WITH DURABLE RESPONSES IN R/R MCL* †
80% ORR [95% CI: 72, 87] 1 ✦ 40% CR [95% CI: 31, 49] 1 ✦ Median DoR not reached at median follow-up of 15.2 months 1
*Independent Review Committee-assessed per 2014 Lugano Classifi cation response criteria for non-Hodgkin lymphoma. 1
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
verifi cation and description of clinical benefi t in
confi rmatory trials.
Consider the benefi t-risk of withholding CALQUENCE
for 3 to 7 days pre- and post-surgery, depending
upon the type of surgery and the risk of bleeding.
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
SELECT SAFETY INFORMATION
to hepatitis B virus (HBV) reactivation and progressive
Hemorrhage
multifocal leukoencephalopathy (PML) have occurred.
Serious hemorrhagic events, including fatal events,
Monitor patients for signs and symptoms of infection
have occurred in the combined safety database of 612 and treat as medically appropriate. Consider prophylaxis
patients with hematologic malignancies treated with in patients who are at increased risk for opportunistic
CALQUENCE monotherapy. Grade 3 or higher bleeding infections.
events, including gastrointestinal, intracranial, and
Cytopenias
epistaxis, have been reported in 2% of patients.
In the combined safety database of 612 patients with
Overall, bleeding events, including bruising and
hematologic malignancies, patients treated with
petechiae of any grade, occurred in approximately
CALQUENCE monotherapy experienced Grade 3 or 4
50% of patients with hematological malignancies.
cytopenias, including neutropenia (23%), anemia
The mechanism for the bleeding events is not
(11%), and thrombocytopenia (8%), based on
well understood.
laboratory measurements. Monitor complete blood
CALQUENCE may further increase the risk of
counts monthly during treatment.
hemorrhage in patients receiving antiplatelet or
anticoagulant therapies, and patients should be
monitored for signs of bleeding.
Please see Brief Summary of complete Prescribing Information on adjacent pages.
CALQUENCE is a registered trademark of the AstraZeneca group of companies ©2018 AstraZeneca. All rights reserved. US-23344 9/18
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.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.FDA.gov/medwatch or call 1-800-FDA-1088.
Investigator-assessed response rates were ORR: 81%; CR: 40%; PR: 41%.
CR=complete response; DoR=duration of response; ORR=overall response
rate (defi ned as the proportion of patients who achieved a CR or PR);
PR=partial response; R/R=relapsed/refractory.
Reference: 1. CALQUENCE [package insert]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; 2017.
†
VISIT CALQUENCE.COM/PHYSICIAN