Brand Name
Calquence
Generic Name
Acalabrutinib
View Brand Information FDA approval date: August 04, 2022
Classification: Kinase Inhibitor
Form: Tablet
What is Calquence (Acalabrutinib)?
CALQUENCE is a kinase inhibitor indicated: In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation .
Approved To Treat
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Brand Information
CALQUENCE (acalabrutinib)
1DOSAGE FORMS AND STRENGTHS
Tablets:100 mg acalabrutinib, orange, oval, film-coated, biconvex, debossed with ‘ACA 100’ on one side and plain on the other.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious and Opportunistic Infections
- Hemorrhage
- Cytopenias
- Second Primary Malignancies
- Cardiac Arrhythmias
- Hepatotoxicity, including DILI
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the Warnings and Precautions reflect exposure to CALQUENCE 100 mg approximately every 12 hours in 1,764 patients with hematologic malignancies. Treatment includes CALQUENCE monotherapy in 1,256 patients in 9 trials, and CALQUENCE combinations in 508 patients in 3 trials. Among these recipients of CALQUENCE, 88% were exposed for at least 6 months and 80% were exposed for at least one year. In this pooled safety population, adverse reactions in ≥ 30% of 1,764 patients, excluding laboratory abnormalities, were diarrhea (37%), upper respiratory tract infection (36%), headache (35%), musculoskeletal pain (33%), lower respiratory tract infection (32%), and fatigue (32%). The most common grade 3 or 4 laboratory abnormalities (≥10%) were absolute neutrophil count decreased (31%), absolute lymphocyte count decreased (23%), platelets decreased (11%), and hemoglobin decreased (10%).
Previously Untreated Mantle Cell Lymphoma
The safety data described below reflect exposure to CALQUENCE (100 mg approximately every 12 hours, with or without BR) in patients with MCL
ECHO
The safety of CALQUENCE in combination with bendamustine and rituximab (CALQUENCE plus BR) was evaluated in 297 patients with previously untreated MCL in ECHO
The median duration of treatment with CALQUENCE was 28.6 months. A total of 171 (57.6%) patients were treated with CALQUENCE for ˃ 24 months and 122 (41.1%) patients were treated for ˃ 36 months.
Serious adverse reactions occurred in 69% of patients who received CALQUENCE plus BR. Serious adverse reactions reported in ≥ 2% of patients were pneumonia (23%; includes COVID-19 pneumonia), COVID-19 (20%; includes COVID-19 pneumonia), pyrexia (6%), second primary malignancy (7%), rash (3.4%), febrile neutropenia (3.4%), atrial fibrillation (3%), sepsis (2.7%), and anemia (2.4%). Fatal adverse reactions that occurred within 30 days of the last study treatment were reported in 12% who received CALQUENCE plus BR including COVID-19 (6%; includes COVID-19 pneumonia), pneumonia (1%), sepsis (0.3%), second primary malignancy (0.7%), and pneumonitis (0.3%).
Adverse reactions led to permanent discontinuation of CALQUENCE in 43%, dosage interruptions in 74%, and dosage reductions in 10% of patients. Adverse reactions that resulted in dosage modification in > 10% included infections, cytopenias, rashes, and gastrointestinal toxicity. Adverse reactions which resulted in permanent discontinuation of CALQUENCE in ≥ 4% of patients included COVID-19 (includes COVID-19 pneumonia) and neutropenia.
Table 4 and Table 5 summarize select adverse reactions and laboratory abnormalities observed in patients treated in ECHO.
Clinically relevant adverse reactions in < 15% of patients receiving CALQUENCE plus BR included bruising, abdominal pain, atrial fibrillation or flutter, and tumor lysis syndrome.
Grade 4 laboratory abnormalities in > 15% of patients treated with CALQUENCE plus BR include absolute lymphocyte count decreased (26%), absolute neutrophil count decreased (36%), and uric acid increased (17%).
Previously Treated Mantle Cell Lymphoma
ACE-LY-004
The safety data described in this section reflect exposure to CALQUENCE (100 mg approximately every 12 hours) in 124 patients with previously treated MCL in Trial LY-004
The most common adverse reactions (≥ 20%) of any grade were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. Grade 1 severity for the non-hematologic, most common events were as follows: headache (25%), diarrhea (16%), fatigue (20%), myalgia (15%), and bruising (19%). The most common Grade ≥ 3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea.
Dose reductions and discontinuation due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively.
Tables 6 and 7 present the frequency category of adverse reactions observed in patients with MCL treated with CALQUENCE.
*Per NCI CTCAE version 4.03.
a Bruising: Includes all terms containing ‘bruise,’ ‘contusion,’ ‘petechiae,’ or ‘ecchymosis’.
b Rash: Includes all terms containing ‘rash’.
c Hemorrhage: Includes all terms containing ‘hemorrhage’ or ‘hematoma’.
*Per NCI CTCAE version 4.03; based on laboratory measurements and adverse reactions.
Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 4.8% of patients.
Chronic Lymphocytic Leukemia
The safety data described below reflect exposure to CALQUENCE (100 mg approximately every 12 hours, with or without obinutuzumab) in 511 patients with CLL from two randomized controlled clinical trials
The most common adverse reactions (≥ 30%) of any grade in patients with CLL were anemia, neutropenia, thrombocytopenia, headache, upper respiratory tract infection, and diarrhea.
ELEVATE-TN
The safety of CALQUENCE plus obinutuzumab (CALQUENCE+G), CALQUENCE monotherapy, and obinutuzumab plus chlorambucil (GClb) was evaluated in a randomized, multicenter, open-label, actively controlled trial in 526 patients with previously untreated CLL
Patients randomized to the CALQUENCE+G arm were treated with CALQUENCE and obinutuzumab in combination for six cycles, then with CALQUENCE as monotherapy until disease progression or unacceptable toxicity. Patients initiated obinutuzumab on Day 1 of Cycle 2, continuing for a total of 6 cycles. Patient randomized to CALQUENCE monotherapy received CALQUENCE approximately every 12 hours until disease progression or unacceptable toxicity. The trial required age ≥ 65 years of age or 18 to < 65 years of age with a total Cumulative Illness Rating Scale (CIRS) > 6 or creatinine clearance of 30 to 69 mL/min, hepatic transaminases ≤ 3 times ULN and total bilirubin ≤ 1.5 times ULN, and allowed patients to receive antithrombotic agents other than warfarin or equivalent vitamin K antagonists.
During randomized treatment, the median duration of exposure to CALQUENCE in the CALQUENCE+G and CALQUENCE monotherapy arms was 27.7 months (range 0.3 to 40 months), with 95% and 92% and 89% and 86% of patients with at least 6 months and 12 months of exposure, respectively. In the obinutuzumab and chlorambucil arm the median number of cycles was 6 with 84% of patients receiving at least 6 cycles of obinutuzumab, 70% of patients received at least 6 cycles of chlorambucil. Eighty-five percent of patients in the CALQUENCE+G arm received at least 6 cycles of obinutuzumab.
In the CALQUENCE+G and CALQUENCE monotherapy arms, 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+G arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (2.8% to 7%).
In the CALQUENCE+G arm, adverse reactions led to treatment discontinuation in 11% of patients and a dose reduction of CALQUENCE in 7% of patients. In the CALQUENCE monotherapy arm, adverse reactions led to discontinuation in 10% and dose reduction in 4% of patients.
Tables 8 and 9 present adverse reactions and laboratory abnormalities identified in the ELEVATE-TN trial.
*Per NCI CTCAE version 4.03.
† Includes any adverse reactions involving infection or febrile neutropenia.
‡ Includes 3 fatal cases in the CALQUENCE plus obinutuzumab arm, 3 fatal cases in the CALQUENCE monotherapy arm and 1 fatal case in the obinutuzumab plus chlorambucil arm.
§ Includes upper respiratory tract infection, nasopharyngitis and sinusitis.
a Includes pneumonia, lower respiratory tract infection, bronchitis, bronchiolitis, tracheitis, and lung infection.
b Derived from adverse reaction and laboratory data.
c Includes neutropenia, neutrophil count decreased, and related laboratory data.
d Includes anemia, red blood cell count decreased, and related laboratory data.
e Includes thrombocytopenia, platelet count decreased, and related laboratory data.
f Includes lymphocytosis, lymphocyte count increased, and related laboratory data.
g Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity and spinal pain.
h Includes asthenia, fatigue, and lethargy.
i Includes bruise, contusion, and ecchymosis.
j Includes rash, dermatitis, and other related terms.
k Includes hemorrhage, hematoma, hemoptysis, hematuria, menorrhagia, hemarthrosis, and epistaxis.
Other clinically relevant adverse reactions (all grades incidence < 15%) in recipients of CALQUENCE (CALQUENCE in combination with obinutuzumab and monotherapy) included:
- Neoplasms: second primary malignancy (10%), non-melanoma skin cancer (5%)
- Cardiac disorders: atrial fibrillation or flutter (3.6%), hypertension (5%)
- Infection: herpesvirus infection (6%)
Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.
ASCEND
The safety of CALQUENCE in patients with relapsed or refractory CLL was evaluated in a randomized, open-label study (ASCEND)
In ASCEND, 154 patients received CALQUENCE (100 mg approximately every 12 hours until disease progression or unacceptable toxicity), 118 received idelalisib (150 mg approximately every 12 hours until disease progression or unacceptable toxicity) with up to 8 infusions of a rituximab product, and 35 received up to 6 cycles of bendamustine and a rituximab product. The median age overall was 68 years (range: 32-90); 67% were male; 92% were white; and 88% had an ECOG performance status of 0 or 1.
In the CALQUENCE arm, 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.
In recipients of CALQUENCE, permanent discontinuation due to an adverse reaction occurred in 10% of patients, most frequently due to second primary malignancies followed by infection. Adverse reactions led to dosage interruptions of CALQUENCE in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and dose reduction in 3.9% of patients.
Selected adverse reactions are described in Table 10 and non-hematologic laboratory abnormalities are described in Table 11. These tables reflect exposure to CALQUENCE with median duration of 15.7 months with 94% of patients on treatment for greater than 6 months and 86% of patients on treatment for greater than 12 months. The median duration of exposure to idelalisib was 11.5 months with 72% of patients on treatment for greater than 6 months and 48% of patients on treatment for greater than 12 months. Eighty-three percent of patients completed 6 cycles of bendamustine and rituximab product.
* Per NCI CTCAE version 4.03.
† Includes any adverse reactions involving infection or febrile neutropenia.
‡ Includes 1 fatal case in the CALQUENCE monotherapy arm and 1 fatal case in the Idelalisib plus Rituximab arm.
§ Includes upper respiratory tract infection, rhinitis and nasopharyngitis.
a Includes pneumonia, lower respiratory tract infection, bronchitis, bronchiolitis, tracheitis, and lung infection.
b Derived from adverse reaction and laboratory data.
c Includes neutropenia, neutrophil count decreased, and related laboratory data.
d Includes anemia, red blood cell decreased, and related laboratory data.
e Includes thrombocytopenia, platelet count decreased, and related laboratory data.
f Includes lymphocytosis, lymphocyte count increased and related laboratory data.
g Includes colitis, diarrhea, and enterocolitis.
h Includes hemorrhage, hematoma, hemoptysis, hematuria, menorrhagia, hemarthrosis, and epistaxis.
i Includes asthenia, fatigue, and lethargy.
j Includes back pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal discomfort, pain in extremity, myalgia, spinal pain and bone pain.
Other clinically relevant adverse reactions (all grades incidence < 15%) in recipients of CALQUENCE included:
- Skin and subcutaneous disorders: bruising (10%), rash (9%)
- Neoplasms: second primary malignancy (12%), non-melanoma skin cancer (6%)
- Musculoskeletal and connective tissue disorders: arthralgia (8%)
- Cardiac disorders: atrial fibrillation or flutter (5%), hypertension (3.2%)
- Infection: herpesvirus infection (4.5%)
Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of CALQUENCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiac disorders: ventricular arrhythmias
- Hepatobiliary disorder: Drug induced liver injury
4DESCRIPTION
CALQUENCE (acalabrutinib) is a kinase inhibitor. The molecular formula for acalabrutinib maleate is C
The chemical structure of acalabrutinib is shown below:
Acalabrutinib maleate is a white to pale brown powder with pH-dependent solubility. It is freely soluble in water at pH values below 3 and practically insoluble at pH values above 6.
CALQUENCE tablets are for oral administration. Each tablet contains 100 mg of acalabrutinib (equivalent to 129 mg of acalabrutinib maleate). Inactive ingredients in the tablet core are low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet coating consists of copovidone, ferric oxide yellow, ferric oxide red, hypromellose, medium-chain triglycerides, polyethylene glycol 3350, purified water and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Storage
Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Serious and Opportunistic Infections
Inform patients of the possibility of serious infection and to report signs or symptoms suggestive of infection
Hemorrhage
Inform patients to report signs or symptoms of bleeding. Inform patients that CALQUENCE may need to be interrupted for major surgeries
Cytopenias
Inform patients that they will need periodic blood tests to check blood counts during treatment with CALQUENCE
Second Primary Malignancies
Inform patients that other malignancies have been reported in patients who have been treated with CALQUENCE, including skin cancer and other solid tumors. Advise patients to use sun protection
Cardiac Arrhythmias
Counsel patients to report any signs of palpitations, dizziness, fainting, chest discomfort, and shortness of breath
Hepatotoxicity, including Drug Induced Liver Injury:
Inform patients that liver problems, including drug-induced liver injury and abnormalities in liver tests, may develop during CALQUENCE treatment. Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice
Pregnancy Complication
CALQUENCE may cause fetal harm and dystocia. Advise women to use effective contraception during treatment and for 1 week after the last dose of CALQUENCE
Lactation
Advise females not to breastfeed during treatment with CALQUENCE and for 2 weeks after the last dose
Dosing Instructions
Instruct patients to take CALQUENCE orally twice daily, about 12 hours apart. CALQUENCE may be taken with or without food. Advise patients that CALQUENCE tablets should be swallowed whole with a glass of water, without chewing, crushing, dissolving, or cutting
Missed Dose
Advise patients that if they miss a dose of CALQUENCE, they may still take it up to 3 hours after the time they would normally take it. If more than 3 hours have elapsed, they should be instructed to skip that dose and take their next dose of CALQUENCE at the usual time. Warn patients they should not take extra tablets to make up for the dose that they missed
Drug Interactions
Advise patients to inform their healthcare providers of all concomitant medications, including over‑the‑counter medications, vitamins and herbal products
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
CALQUENCE is a registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2025
7PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 1/2025
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-3512-60
CALQUENCE
(acalabrutinib) tablets
100 mg
Rx only
Do not chew, crush, dissolve, or cut tablets
Manufactured for:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
By: AstraZeneca AB
SE-151 85 Södertälje Sweden
Product of Switzerland
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-4513-60
CALQUENCE
(acalabrutinib) tablets
100 mg
Rx only
Do not chew, crush, dissolve, or cut
tablets
Manufactured for:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
AstraZeneca
60 tablets
