EXPLORE LONG-TERM DATA  EXPLORE LONG-TERM DATA

EXPLORE THE TABLET FORMULATION:
NO RESTRICTIONS WITH PPIs1  EXPLORE THE TABLET FORMULATION:
NO RESTRICTIONS WITH PPIs1 

CALQUENCE CONFIDENCE

Choose Indication

For CLL/SLL

The #1 prescribed BTKi for patients starting CLL treatment*10 

*Based on April 2024 IMS new patient start claims data.10

Next-generation BTKi with
6-year data and
low CV risk
in previously untreated
CLL1,2

~5-year efficacy data2

UNPRECEDENTED PFS BENEFIT1

PFS RISK REDUCTION

90%

CALQUENCE + obinutuzumab vs GClb

IRC-assessed PFS (primary endpoint): HR=0.10 (95% CI:
0.06-0.17), P<0.0001, at 28.3-month median follow-up (range:
0.0-40.8 months) in previously untreated CLL (n=179).1

PFS risk reduction†

with CALQUENCE + obinutuzumab‡ vs GClb

|

6-YEAR LONG-TERM FOLLOW-UP2

ESTIMATED 6-YEAR PFS RATE

78%

CALQUENCE + obinutuzumab

INV-assessed PFS at 74.5-month median follow-up (range:
0.0-89.0 months) in previously untreated CLL (n=179).2

The 74.5-month median follow-up data from ELEVATE-TN are not in the Prescribing Information for CALQUENCE. The timing for long-term follow-up was not prespecified, and the analysis was descriptive in nature.

  • Proven efficacy as both a combination therapy and monotherapy2 
  • PFS benefit consistent across subgroups, including in high-risk patients2
SEE EFFICACY DATA

†Based on Cox proportional-hazards model stratified by del(17p) status (yes vs no based on interactive voice/web response system).2

‡Based on log-rank test stratified by del(17p) status (yes vs no based on interactive voice/web response system).2

§Estimated 60-month OS rate in ELEVATE-TN. Median OS not reached in any arm. OS was a secondary endpoint and OS data were immature at 58.2-month median follow-up.2

CALQUENCE Study Design for ELEVATE-TN in Patients with Previously Untreated CLL.
CALQUENCE Study Design for ELEVATE-TN in Patients with Previously Untreated CLL.

Low incidence of
cardiovascular
AEs
with
CALQUENCE
monotherapy in

previously untreated
CLL†2,3

Cardiovascular Events Icon
Cardiovascular Events Icon
  At 28.3 month
follow-up3		 At 58.2 month
follow-up2
Atrial fibrillation
(Any grade)		 4% 7%
Hypertension
(Any grade)		 5% 9%
Bleeding
(Grade ≥3)		 2% 3%

§In previously untreated CLL (n=179 in ELEVATE-TN).2,3

CALQUENCE Adverse Events in Previously Untreated CLL
CALQUENCE Adverse Events in Previously Untreated CLL

ELEVATE-TN: Safety and tolerability results at 58.2-month median follow-up were consistent with the interim analysis. The most common AEs (≥30%, any grade) in the CALQUENCE + obinutuzumab arm (n=178) were infection (79%), bleeding (49%), diarrhea (43%), headache (40%), arthralgia (34%), and neutropenia (34%). The most common AEs (≥30%, any grade) in the CALQUENCE monotherapy arm (n=179) were infection (75%), bleeding (44%), diarrhea (43%), and headache (39%).2

 

ELEVATE-RR: At 41-month median follow-up, the most common AEs (≥20%, any grade) in patients receiving CALQUENCE (n=266)/ibrutinib (n=263) were infections (78%/81%), bleeding (38%/51%), diarrhea (35%/46%), headache (35%/20%), cough (29%/21%), cardiac events (24%/30%), pyrexia (23%/19%), anemia (22%/19%), neutropenia (21%/25%), fatigue (20%/17%), arthralgia (16%/23%), and hypertension (9%/23%).3

 

ASCEND: Safety and tolerability results at 46.5-month median follow-up were consistent with the interim analysis. The most common AEs (≥20%, any grade) in patients receiving CALQUENCE (n=154) were infection (68%), hemorrhage (31%),  neutropenia (24%), headache (23%), and diarrhea (21%).4

At 28.3-month median follow-up in ELEVATE-TN, the most common ARs (≥30%) of any grade in patients treated with CALQUENCE + obinutuzumab (n=178) were infection (69%), neutropenia (53%), anemia (52%), thrombocytopenia (51%), headache (40%), diarrhea (39%), musculoskeletal pain (37%), fatigue (34%), and bruising (31%). In the CALQUENCE monotherapy arm (n=179), the most common ARs (≥30%) of any grade were infection (65%), anemia (53%), headache (39%), diarrhea (35%), musculoskeletal pain (32%), and thrombocytopenia (32%).1

Safety and tolerability at 74.5-month median follow-up were consistent with the interim analysis, apart from COVID-19, which was observed during the pandemic.2

The 74.5-month median follow-up data from ELEVATE-TN are not in the Prescribing Information for CALQUENCE.

In a pooled analysis of 1029 patients with CALQUENCE, Grade 3 or higher ventricular arrhythmia events were reported in 0.9% of patients.

||Events inclusive of preferred group terms and are not limited to cardiovascular body system.2-4

58.2-month median follow-up (CALQUENCE + obinutuzumab; n=178 and CALQUENCE monotherapy; n=179) in the ELEVATE-TN trial.2

#41-month median follow-up (CALQUENCE; n=266 and ibrutinib; n=263) in the ELEVATE-RR trial.3

**Grade ≥3 atrial fibrillation/flutter events were 4.9% for CALQUENCE and 3.8% for ibrutinib.3

††46.5-month median follow-up (CALQUENCE; n=154) in the ASCEND trial.4

Studied in multiple Phase 3 trials in CLL3-5

ELEVATE-TN: CALQUENCE ± G vs GClbPREVIOUSLY UNTREATED CLL

The first Phase 3 study of a BTKi
with and without obinutuzumab
vs chemoimmunotherapy3

ELEVATE-TN Previously Untreated CLL
ELEVATE-TN Previously Untreated CLL
VIEW 6-Year Data2

ELEVATE-RR: CALQUENCE vs ibrutinibRELAPSED/REFRACTORY CLL

The first Phase 3 study of a next-generation BTKi
vs ibrutinib in R/R CLL4

ELEVATE-RR CALQUENCE vs Ibrutinib
ELEVATE-RR CALQUENCE vs Ibrutinib
View ~3.5-Year Data4

ASCEND: CALQUENCE vs IdR/BRRELAPSED/REFRACTORY CLL

The first Phase 3 study of a
BTKi vs investigator’s choice
of IdR or BR5

ASCEND Relapsed/Refractory CLL
ASCEND Relapsed/Refractory CLL
View ~4-Year Data6

POOLED
CARDIOVASCULAR SAFETY

Analysis of select cardiovascular
adverse events with CALQUENCE
across 4 CLL
clinical trials7 

Pooled Cardiovascular Safety
Pooled Cardiovascular Safety

Hear about Dr Danilov's experience prescribing CALQUENCE

Kinase Selectivity
Kinase Selectivity

Delivering focused kinase inhibition and limited off-target enzyme inhibition in preclinical models8,9

EXPLORE
The
Science
Dosage and Administration
Dosage & Administration

Continuous BTK inhibition with one tablet taken orally twice daily1

VIEW TABLET
DOSAGE
INFORMATION
Patient Support and Resources
Patient Financial Support

Learn about financial assistance options for your patients

 

AEs=adverse events; BR=bendamustine + rituximab; BTKi=Bruton tyrosine kinase inhibitor; CI=confidence interval; CLL=chronic lymphocytic leukemia; CV=cardiovascular; G=obinutuzumab; GClb=obinutuzumab + chlorambucil; HR=hazard ratio; IdR=idelalisib + rituximab; INV=investigator; IRC=Independent Review Committee; NCCN=National Comprehensive Cancer Network; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PPI=proton pump inhibitors; R/R=relapsed/refractory; SLL=small lymphocytic lymphoma.

  • CALQUENCE® (acalabrutinib) tablets [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.   
  • Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of ELEVATE-TN [abstract and presentation]. Presented at: American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023. San Diego, CA. Abs 636.
  • Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-naive chronic lymphocytic leukemia (ELEVATE-TN): a randomised, controlled, phase 3 trial [published correction appears in Lancet. 2020;395(10238):1694]. Lancet. 2020;395(10232):1278-1291.
  • Byrd JC, Hillmen P, Ghia P, et al. Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: results of the first randomized phase III trial. J Clin Oncol. 2021;39(31):3441-3452 and supplementary appendix.
  • Ghia P, Pluta A, Wach M, et al. ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol. 2020;38(25):2849-2861.
  • Ghia P, Pluta A, Wach M, et al. Acalabrutinib versus investigator's choice in relapsed/refractory chronic lymphocytic leukemia: final ASCEND trial results. Hemasphere. 2022;6(12):e801.
  • Brown JR, Byrd JC, Ghia P, et al. Cardiovascular adverse events in patients with chronic lymphocytic leukemia receiving acalabrutinib monotherapy: pooled analysis of 762 patients. Haematologica. 2022;107(6):1335-1346.
  • Barf T, Covey T, Izumi R, et al. Acalabrutinib (ACP-196): a covalent Bruton tyrosine kinase inhibitor with a differentiated selectivity and in vivo potency profile. J Pharmacol Exp Ther. 2017;363(2):240-252.
  • Podoll T, Pearson PG, Kaptein A, et al. Identification and characterization of ACP-5862, the major circulating active metabolite of acalabrutinib: both are potent and selective covalent Bruton tyrosine kinase inhibitors . J Pharmacol Exp Ther. 2023;384(1):173-186.
  • Data on File, US-90733. AstraZeneca Pharmaceuticals LP.
Read More
IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

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

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

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

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 jirovecii 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.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. 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. Grade 3 or higher ventricular arrhythmia events were reported in 0.9% of patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE.

Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.

ADVERSE REACTIONS

The most common adverse reactions (≥30%) of any grade in patients with CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

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

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively).

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection.

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection. Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

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 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 2 weeks after the last dose.

Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

INDICATION AND USAGE

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

You may report side effects related to AstraZeneca products by clicking here.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

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

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

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

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 jirovecii 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.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. 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. Grade 3 or higher ventricular arrhythmia events were reported in 0.9% of patients. The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE.

Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE. Upon confirmation of DILI, discontinue CALQUENCE.

ADVERSE REACTIONS

The most common adverse reactions (≥30%) of any grade in patients with CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

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

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively).

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection.

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection. Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

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 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 2 weeks after the last dose.

Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

INDICATION AND USAGE

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products.

You may report side effects related to AstraZeneca products by clicking here.

Read More