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Calquence

Last reviewed on RxList: 12/2/2019
Calquence Side Effects Center

Last reviewed on RxList 12/2/2019

What Is Calquence?

Calquence (acalabrutinib) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

What Are Side Effects of Calquence?

Common side effects of Calquence include:

Dosage for Calquence

The recommended dose of Calquence is 100 mg orally approximately every twelve hours; swallow whole with water and with or without food.

What Drugs, Substances, or Supplements Interact with Calquence?

Calquence may interact with:

  • itraconazole,
  • clarithromycin,
  • telithromycin,
  • nefazodone,
  • ketoconazole,
  • atazanavir,
  • darunavir,
  • indinavir,
  • lopinavir,
  • nelfinavir,
  • ritonavir,
  • saquinavir,
  • tipranavir,
  • rifampin,
  • proton pump inhibitors (PPIs),
  • H2-receptor antagonists,
  • and antacids.

Tell your doctor all medications and supplements you use.

Calquence During Pregnancy and Breastfeeding

Calquence is not recommended for use during pregnancy; it may harm a fetus. It us unknown if Calquence passes into breast milk. Due to the potential for adverse reactions in a breastfed child, breastfeeding is not recommended while using Calquence and for at least 2 weeks after the final dose.

Additional Information

Our Calquence (acalabrutinib) Capsules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Calquence Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Serious and Opportunistic Infections [see WARNINGS AND PRECAUTIONS]
  • Hemorrhage [see WARNINGS AND PRECAUTIONS]
  • Cytopenias [see WARNINGS AND PRECAUTIONS]
  • Second Primary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Atrial Fibrillation and Flutter [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

As 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 1029 patients with hematologic malignancies. Treatment includes CALQUENCE monotherapy in 820 patients in 6 trials, and CALQUENCE with obinutuzumab in 209 patients in 2 trials. Among these recipients of CALQUENCE, 88% were exposed for at least 6 months and 79% were exposed for at least one year. In this pooled safety population, adverse reactions in ≥ 30% of 1029 patients were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

Mantle Cell Lymphoma

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 [see Clinical Studies]. The median duration of treatment with CALQUENCE was 16.6 (range: 0.1 to 26.6) months. A total of 91 (73.4%) patients were treated with CALQUENCE for ≥ 6 months and 74 (59.7%) patients were treated for ≥ 1 year.

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 3 and 4 present the frequency category of adverse reactions observed in patients with MCL treated with CALQUENCE.

Table 3: Non-Hematologic Adverse Reactions in ≥ 5% (All Grades) of Patients with MCL in Trial LY-004

Body System
Adverse Reactions
CALQUENCE Monotherapy
N=124
All Grades (%) Grade ≥ 3 (%)
Nervous system disorders
Headache 39 1.6
Gastrointestinal disorders
Diarrhea 31 3.2
Nausea 19 0.8
Abdominal pain 15 1.6
Constipation 15 -
Vomiting 13 1.6
General disorders
Fatigue 28 0.8
Musculoskeletal and connective tissue disorders
Myalgia 21 0.8
Skin and subcutaneous tissue disorders
Bruisinga 21 -
Rashb 18 0.8
Vascular disorders
Hemorrhagec 8 0.8
Respiratory, thoracic and mediastinal disorders
Epistaxis 6 -
*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'

Table 4: Hematologic Adverse Reactions Reported in ≥ 20% of Patients with MCL in Trial LY-004

Hematologic Adverse Reactions* CALQUENCE Monotherapy
N=124
All Grades (%) Grade ≥ 3 (%)
Hemoglobin decreased 46 10
Platelets decreased 44 12
Neutrophils decreased 36 15
*Per NCI CTCAE version 4.03; based on laboratory measurements and adverse reactions.

Increases in creatinine 1.5 to 3 times the upper limit of normal 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 [see Clinical Studies].

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 [see Clinical Studies].

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 upper limit of normal (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 5 and 6 presents adverse reactions and laboratory abnormalities identified in the ELEVATE-TN trial.

Table 5: Common Adverse Reactions (≥ 15% Any Grade) with CALQUENCE in Patients with CLL (ELEVATE-TN)

Body System Adverse Reaction* CALQUENCE plus Obinutuzumab
N=178
CALQUENCE Monotherapy
N=179
Obinutuzumab plus Chlorambucil
N=169
All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%)
Infections
Infectiot† 69 22‡ 65 14‡ 46 13‡
Upper respiratory tract infectiona 39 2.8 35 0 17 1.2
Lower respiratory tract infectionb 24 8 18 4.5 7 1.8
Urinary tract infection 15 1.7 15 2.8 5 0.6
Blood and lymphatic system disorders§
Neutropeniac 53 37 23 13 78 50
Anemiad 52 12 53 10 54 14
Thrombocytopeniae 51 12 32 3.4 61 16
Lymphocytosisf 12 11 16 15 0.6 0.6
Nervous system disorders
Headache 40 1.1 39 1.1 12 0
Dizziness 20 0 12 0 7 0
Gastrointestinal disorders
Diarrhea 39 4.5 35 0.6 21 1.8
Nausea 20 0 22 0 31 0
Musculoskeletal and connective tissue disorders
Musculoskeletal paing 37 2.2 32 1.1 16 2.4
Arthralgia 22 1.1 16 0.6 4.7 1.2
General disorders and administration site conditions
Fatigueh 34 2.2 23 1.1 24 1.2
Skin and subcutaneous tissue disorders
Bruisingi 31 0 21 0 5 0
Rashj 26 2.2 25 0.6 9 0.6
Vascular disorders
Hemorrhagek 20 1.7 20 1.7 6 0
*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
§ Derived from adverse reaction and laboratory data
a Upper respiratory tract infection, nasopharyngitis and sinusitis
b Includes pneumonia, lower respiratory tract infection, bronchitis, bronchiolitis, tracheitis, and lung infection
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%)

Table 6: Select Non-Hematologic Laboratory Abnormalities (≥ 15% Any Grade), New or Worsening from Baseline in Patients Receiving CALQUENCE (ELEVATE-TN)

Laboratory Abnormality*,a CALQUENCE plus Obinutuzumab
N=178
CALQUENCE Monotherapy
N=179
Obinutuzumab plus Chlorambucil
N=169
All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%)
Uric acid increase 29 29 22 22 37 37
ALT increase 30 7 20 1.1 36 6
AST increase 38 5 17 0.6 60 8
Bilirubin increase 13 0.6 15 0.6 11 0.6
*Per NCI CTCAE version 4.03
a Excludes electrolytes

Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively.

ASCEND

:yu ai3unR c3 8f6hSrm8r Cs 7inCusna bCny ouIi7aue co ou3oilncoR 866 bia uAiIDinue Cs i oisecPCEuej c7uswIi2uI anDeR dfM8rmp. [see Clinical Studies]. The trial enrolled patients with relapsed or refractory CLL after at least one prior therapy and required hepatic transaminases ≤ 2 times upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN, and an estimated creatinine clearance ≥ 30 mL/min. The trial excluded patients having an absolute neutrophil count < 500/μL, platelet count < 30,000/μL, prothrombin time or activated partial thromboplastin time > 2 times ULN, significant cardiovascular disease, or a requirement for strong CYP3A inhibitors or inducers. Patients were allowed to receive antithrombotic agents other than warfarin or equivalent vitamin K antagonist.

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 7 and non-hematologic laboratory abnormalities are described in Table 8. 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.

Table 7: Common Adverse Reactions (≥ 15% Any Grade) with CALQUENCE in Patients with CLL (ASCEND)

Body System Adverse Reaction* CALQUENCE
N=154
Idelalisib plus Rituximab Product
N=118
Bendamustine plus Rituximab Product
N=35
All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%)
Infections
Infectiot† 56 15* 65 28* 49 11
Upper respiratory tract infectiona 29 1.9 26 3.4 17 2.9
Lower respiratory tract infectionb 23 6 26 15 14 6
Blood and lymphatic system disorders§
Neutropeniac 48 23 79 53 80 40
Anemiad 47 15 45 8 57 17
Thrombocytopeniae 33 6 41 13 54 6
Lymphocytosisf 26 19 23 18 2.9 2.9
Nervous system disorders
Headache 22 0.6 6 0 0 0
Gastrointestinal disorders
Diarrheag 18 1.3 49 25 14 0
Vascular disorders
Hemorrhageh 16 1.3 5 1.7 6 2.9
General disorders
Fatiguei 15 1.9 13 0.8 31 6
Musculoskeletal and connective tissue disorders
Musculoskeletal painj 15 1.3 15 1.7 2.9 0
* 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
§ Derived from adverse reaction and laboratory data
a Upper respiratory tract infection, rhinitis and nasopharyngitis
b Includes pneumonia, lower respiratory tract infection, bronchitis, bronchiolitis, tracheitis, and lung infection.
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%)

Table 8: Select Non-Hematologic Laboratory Abnormalities (≥ 10% Any Grade), New or Worsening from Baseline in Patients Receiving CALQUENCE (ASCEND)

Laboratory Abnormalitya CALQUENCE
N=154
Idelalisib plus Rituximab Product
N=118
Bendamustine plus Rituximab Product
N==35
All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%)
Uric acid increase 15 15 11 11 23 23
ALT increase 15 1.9 59 23 26 2.9
AST increase 13 0.6 48 13 31 2.9
Bilirubin increase 13 1.3 16 1.7 26 11
Per NCI CTCAE version 5
a Excludes electrolytes

Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE.

Read the entire FDA prescribing information for Calquence (Acalabrutinib Capsules)

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© Calquence Patient Information is supplied by Cerner Multum, Inc. and Calquence Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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