1 INDICATIONS AND USAGE
CALQUENCE is 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 [see Clinical
Studies (14)]. Continued approval for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of CALQUENCE is 100 mg taken orally approximately every twelve hours until
disease progression or unacceptable toxicity.
Advise patients to swallow capsule whole with water. Advise patients not to open, break or chew the
capsules. CALQUENCE may be taken with or without food. If a dose of CALQUENCE 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 of CALQUENCE should not be taken to make up for a missed dose
WARNINGS AND PRECAUTIONS
5.1 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 3-7 days preand
post-surgery depending upon the type of surgery and the risk of bleeding.
Reference ID: 4174611
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5.2 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. Consider prophylaxis in patients who are at increased risk for opportunistic
infections.
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.
5.3 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. In the CALQUENCE clinical
Trial LY-004, patients" complete blood counts were assessed monthly during treatment.
5.4 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.
5.5 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.