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Indications & Usage

INDICATIONS AND USAGE

 

CALQUENCE is a kinase 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.

·        Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

 

 

Please see full Prescribing Information, including Patient Information.

Dosage & Administration

DOSAGE AND ADMINISTRATION

 

·        Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food.

·        Advise patients not to break, open, or chew capsules.

·        Manage toxicities using treatment interruption, dose reduction, or discontinuation.

·        Avoid CALQUENCE in patients with severe hepatic impairment

 

 

DOSAGE FORMS AND STRENGTHS

 

Capsules: 100 mg.

 

 

Please see full Prescribing Information, including Patient Information.

Contraindications

CONTRAINDICATIONS

 

None.


 

Please see full Prescribing Information, including Patient Information.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

 

·        Serious and Opportunistic Infections:  Monitor for signs and symptoms of infection and treat promptly.

·        Hemorrhage: Monitor for bleeding and manage appropriately.

·        Cytopenias: Monitor complete blood counts regularly.

·        Second Primary Malignancies: Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection.

·        Atrial Fibrillation and Flutter: Monitor for symptoms of arrhythmias and manage.

 

  

Please see full Prescribing Information, including Patient Information.

Adverse Reactions

ADVERSE REACTIONS

 

Most common adverse reactions (incidence ≥ 30%) were: anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

 

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

 

Please see full Prescribing Information, including Patient Information.

Drug Interactions

DRUG INTERACTIONS

 

·        CYP3A Inhibitors: Avoid co-administration with strong CYP3A inhibitors.  Dose adjustments may be recommended.

·        CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Dose adjustments may be recommended.

·        Gastric Acid Reducing Agents: Avoid co-administration with proton pump inhibitors (PPIs). Stagger dosing with H2-receptor antagonists and antacids.

 

 

Please see full Prescribing Information, including Patient Information.

Use in Specific Populations

USE IN SPECIFIC POPULATIONS

 

·        Pregnancy: May cause fetal harm and dystocia

·        Lactation: Advise not to breastfeed.

 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

 

 

Please see full Prescribing Information, including Patient Information.

For US health care professionals.

CALQUENCE is a registered trademark and CALQUENCE Cares and AstraZeneca Access 360 are trademarks of the AstraZeneca group of companies. AstraZeneca Access 360 does not guarantee reimbursement. ©2020 AstraZeneca. All rights reserved. US-40625 Last Updated 6/20

Please see full Prescribing Information, including Patient 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.

 

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 (≥20%) of any grade in patients with MCL were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%).

 

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

 

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 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.