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Acalabrutinib: Drug information

Acalabrutinib: Drug information
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For additional information see "Acalabrutinib: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Calquence
Brand Names: Canada
  • Calquence
Pharmacologic Category
  • Antineoplastic Agent;
  • Antineoplastic Agent, Bruton Tyrosine Kinase Inhibitor;
  • Antineoplastic Agent, Tyrosine Kinase Inhibitor
Dosing: Adult

Dosage guidance:

Safety: Due to the potential bleeding risk, consider benefit-risk of interrupting acalabrutinib treatment for 3 to 7 days prior to and after surgery (depending on the type of surgery and the risk of bleeding).

Dosage form information: Calquence capsules have been discontinued in the United States >1 year.

Clinical considerations: Consider prophylaxis in patients who are at increased risk for opportunistic infections.

Chronic lymphocytic leukemia/small lymphocytic lymphoma

Chronic lymphocytic leukemia/small lymphocytic lymphoma:

Single-agent therapy: Oral: 100 mg approximately every 12 hours; continue until disease progression or unacceptable toxicity (Ref).

Combination therapy (previously untreated patients): Oral: 100 mg approximately every 12 hours; continue until disease progression or unacceptable toxicity; begin acalabrutinib at cycle 1 (each cycle is 28 days); obinutuzumab is administered for 6 cycles beginning at cycle 2 (Ref).

Mantle cell lymphoma

Mantle cell lymphoma :

Single agent therapy (previously treated patients): Oral: 100 mg approximately every 12 hours; continue until disease progression or unacceptable toxicity (Ref).

Combination therapy (previously untreated patients): Oral: 100 mg approximately every 12 hours beginning at cycle 1 (in combination with bendamustine and rituximab for a total of 6 cycles [each cycle is 28 days]); continue acalabrutinib until disease progression or unacceptable toxicity (in combination with rituximab [every other cycle] in patients achieving a response [complete response or partial response] for a maximum of 12 additional maintenance rituximab doses [starting on cycle 8 up to cycle 30]).

Waldenström macroglobulinemia

Waldenström macroglobulinemia (off-label use): Oral: 100 mg twice daily; continue until disease progression or unacceptable toxicity (Ref).

Missed doses: If a dose is missed by >3 hours, omit that dose and administer the next dose at the regularly scheduled time; do not administer extra doses to make up for a missed dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Kidney function estimated using the MDRD (modification of diet in renal disease) equation.

eGFR ≥30 to <90 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling; however, there are no clinically significant differences in acalabrutinib (or the active metabolite) pharmacokinetics.

eGFR <30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (effect on pharmacokinetics is unknown).

eGFR <30 mL/minute/1.73 m2 requiring dialysis: There are no dosage adjustments provided in the manufacturer's labeling (effect on pharmacokinetics is unknown).

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment:

Mild to moderate impairment (Child-Turcotte-Pugh classes A and B): No dosage adjustment necessary.

Severe impairment (Child-Turcotte-Pugh class C): Avoid use.

Acute hepatotoxicity during treatment:

Drug-induced liver injury: Withhold acalabrutinib if suspected; discontinue acalabrutinib upon confirmation.

Dosing: Adjustment for Toxicity: Adult

Note: Other concomitant anticancer therapies may also require treatment interruption, dosage reduction, and/or discontinuation.

Acalabrutinib (as a Single Agent or in Combination With Obinutuzumab) Recommended Dosage Modifications for Adverse Reactions

Adverse reaction

Occurrence

Acalabrutinib dosage modification

Hematologic toxicities: Grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia, or grade 4 neutropenia lasting >7 days

First and second occurrence

Interrupt acalabrutinib until resolved to grade 1 or baseline; then may resume at 100 mg approximately every 12 hours.

Third occurrence

Interrupt acalabrutinib until resolved to grade 1 or baseline; then may resume with the dose reduced to 100 mg once daily.

Fourth occurrence

Discontinue acalabrutinib.

Nonhematologic toxicities, ≥ grade 3

First and second occurrence

Interrupt acalabrutinib until resolved to grade 1 or baseline; then may resume at 100 mg approximately every 12 hours.

Third occurrence

Interrupt acalabrutinib until resolved to grade 1 or baseline; then may resume with the dose reduced to 100 mg once daily.

Fourth occurrence

Discontinue acalabrutinib.

Arrhythmia

Any

Manage as appropriate.

Infection

Any

Manage promptly.

Acalabrutinib (in Combination With Bendamustine and Rituximab) Recommended Dosage Modifications for Adverse Reactions

Adverse reaction

Severity

Recommended dosage modification

a Consider use of myeloid growth factors before bendamustine dose reduction.

b If additional bendamustine dosage reduction beyond 70 mg/m2 is required, consider discontinuation of bendamustine.

c Bendamustine interruption for platelets <50,000/mm3 should occur even in the absence of clinically significant bleeding.

Neutropenia

ANC <1,000/mm3 to 500/mm3

Continue acalabrutinib.

Bendamustine dosage adjustment: Consider bendamustine interruption and dosage reduction to 70 mg/m2 as clinically appropriate.a,b

ANC <500/mm3 for >7 days (first occurrence)

Interrupt acalabrutinib until resolved to ≤ grade 2; then resume at 100 mg approximately every 12 hours.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2; then resume and consider dose reduction to 70 mg/m2.a,b

ANC <500/mm3 for >7 days (second or third occurrence)

Interrupt acalabrutinib treatment until resolved to ≤ grade 2; then resume with the dose reduced to 100 mg once daily.

Acalabrutinib dose may be re-escalated if tolerated at a reduced dose for ≥4 weeks (at physician’s discretion).

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2; then resume and consider dose reduction to 70 mg/m2.a,b

ANC <500/mm3 for >7 days (fourth occurrence)

Discontinue acalabrutinib.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2; then resume and consider dose reduction to 70 mg/m2.a,b

Thrombocytopenia

Platelets 25,000/mm3 to 50,000/mm3 with clinically significant bleeding, or platelets <25,000/mm3 (first occurrence)

Interrupt acalabrutinib until resolved to ≤ grade 2 or baseline; then resume at 100 mg approximately every 12 hours.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; resume and consider dose reduction to 70 mg/m2.b,c

Platelets 25,000/mm3 to 50,000/mm3 with clinically significant bleeding, or platelets <25,000/mm3 (second occurrence)

Interrupt acalabrutinib treatment until resolved to ≤ grade 2 or baseline; then resume with the dose reduced to 100 mg once daily.

Acalabrutinib dose may be re-escalated if tolerated at a reduced dose for ≥4 weeks (at physician’s discretion).

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; resume and consider dose reduction to 70 mg/m2.b,c

Platelets 25,000/mm3 to 50,000/mm3 with clinically significant bleeding, or platelets <25,000/mm3 (third occurrence)

Consider discontinuing acalabrutinib.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; resume and consider dose reduction to 70 mg/m2.b,c

Nonhematologic toxicities

≥ Grade 3 (first occurrence)

Interrupt acalabrutinib until resolved to ≤ grade 2 or baseline; then resume at 100 mg approximately every 12 hours.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; resume and consider dose reduction to 70 mg/m2.b

≥ Grade 3 (second occurrence)

Interrupt acalabrutinib treatment until resolved to ≤ grade 2 or baseline; then resume with the dose reduced to 100 mg once daily.

Acalabrutinib dose may be re-escalated if tolerated at a reduced dose for ≥4 weeks (at physician’s discretion).

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; then resume and consider dose reduction to 70 mg/m2.b

≥ Grade 3 (third occurrence)

Discontinue acalabrutinib for grade 4 toxicity. Consider risks and benefits of continuing acalabrutinib for grade 3 toxicity.

Bendamustine dosage adjustment: Interrupt bendamustine until resolved to ≤ grade 2 or baseline; resume and consider dose reduction to 70 mg/m2.b

Arrhythmia

Any

Manage as appropriate.

Infection

Any

Manage promptly.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Cardiovascular effects

Serious cardiovascular effects have occurred with acalabrutinib, including grades ≥3 atrial fibrillation, hypertension, and ventricular arrhythmia. In a retrospective cohort study, ventricular arrhythmias occurred in ~3% of patients with one case of sudden cardiac death (Ref). Cardiovascular events have occurred in patients with and without preexisting cardiovascular risk factors (Ref).

Mechanism: Atrial fibrillation: Not clearly established; may be due to HER4 inhibition with subsequent decreased PI3K-AKT signaling in the heart (Ref). Hypertension: Not clearly established; may be due to decreased formation of nitric oxide resulting in vascular tone dysregulation (Quartermaine 2023). Ventricular arrhythmias: Not clearly established; does not appear to be caused by QTc prolongation (Ref).

Onset: Delayed; median time to any cardiovascular event: ~10 months (range: ~3 days to ≥4 years) (Ref).

• Atrial fibrillation: Median: ~17 to 29 months (range: ~8 days to ≥4 years) (Ref)

• Hypertension: Median: ~6.5 to 8 months (range: ~3 days to ≥3 years) (Ref)

• Ventricular arrhythmia: Median: ~15 months (range: ~1 month to ≥4 years) (Ref)

Risk factors:

• Hypertension (Ref)

• Diabetes mellitus (Ref)

• Hyperlipidemia (Ref)

• Hypothyroidism (Ref)

• History of atrial fibrillation (Ref)

• Age ≥65 years (Ref)

• Black race (for hypertension) (Ref)

• Body mass index >25 kg/m2 (for hypertension) (Ref)

Hemorrhage

Major hemorrhages (some fatal) have occurred during therapy with acalabrutinib, including grades ≥3 and CNS bleeding events (eg, intracranial hemorrhage). Bleeding events of all grades (eg, bruise, cutaneous, epistaxis, petechia, gastrointestinal) have been reported (Ref).

Mechanism: Dose-related; related to mechanism of action; inhibition of Bruton tyrosine kinase impacts platelet activation likely by targeting collagen-glycogen VI signal transduction (Ref).

Onset: Varied; median time to any grade hemorrhage: ~3 to 5 weeks (range: 0 to ≥3 years) (Ref).

Risk factors:

• Concurrent antiplatelet/anticoagulant therapy (Ref)

• History of prior bleed (Ref)

• Age ≥65 years (Ref)

Infection

Serious infections (some fatal) have occurred during therapy with acalabrutinib, including bacterial infection, fungal infection, viral infection, and opportunistic infections (eg, pneumonia due to Pneumocystis jirovecii, progressive multifocal leukoencephalopathy, reactivation of HBV) (Ref). Other reported infections include upper respiratory tract infection, sinusitis, pneumonia, and urinary tract infection (Ref). Infections predominantly occurred in the absence of neutropenia (Ref). Median duration of infection: ~12 days (Ref).

Mechanism: Related to mechanism of action; inhibition of Bruton tyrosine kinase disrupts signaling pathways of neutrophils, macrophages, and monocytes, leading to increased infection risk. Fungal infection risk may be related to diminished platelet-mediated antifungal effects including decreased hyphal damage and conidia adhesion (Ref).

Onset: Varied; median time to any grade infection: ~3 to 4 months (range: 0 to ≥4 years). Approximately two-thirds of first infection events occurred within the initial 6 months of acalabrutinib therapy (Ref).

Second primary malignancy

Second primary malignancies have occurred during acalabrutinib therapy, including skin carcinoma, lung carcinoma, gastrointestinal carcinoma, genitourinary cancer, and secondary hematologic malignancy (Ref). Second primary malignant neoplasms contributed to treatment discontinuation and death in <5% of treated patients (Ref). In a systematic review and meta-analysis of randomized controlled trials examining acalabrutinib for treatment of chronic lymphocytic leukemia, acalabrutinib therapy (monotherapy or combination) resulted in significantly increased risks of second primary malignancies compared to non-acalabrutinib treatments (Ref). Approximately 50% of second primary malignancies identified were nonmelanoma skin cancers (Ref). A higher baseline CD8 count is associated with a lower risk of second primary malignancy (Ref).

Mechanism: Not clearly established; possibly related to suppression of innate immune response and surveillance resulting from Bruton tyrosine kinase inhibition (Ref).

Onset: Varied; median time to second primary malignancy diagnosis: ~1 to 2 years (range: ~12 days to ≥7 years) (Ref).

Risk factors:

• Chronic lymphocytic leukemia (Ref)

• Smoking (Ref)

• Higher baseline platelet count (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Dermatologic: Skin rash (9% to 25%)

Endocrine & metabolic: Increased uric acid (15% to 22%)

Gastrointestinal: Abdominal pain (15%), constipation (15%), diarrhea (18% to 35%; grades ≥3: ≤3%), nausea (19% to 22%; grades ≥3: <1%), vomiting (13%; grades ≥3: 2%)

Genitourinary: Urinary tract infection (15%) (table 1)

Acalabrutinib: Adverse Reaction: Urinary Tract Infection

Drug (Acalabrutinib)

Comparator (Acalabrutinib plus Obinutuzumab)

Comparator (Obinutuzumab plus Chlorambucil)

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Acalabrutinib plus Obinutuzumab)

Number of Patients (Obinutuzumab plus Chlorambucil)

15%

15%

5%

Chronic lymphocytic leukemia

179

178

169

Hematologic & oncologic: Anemia (47% to 53%; grades ≥3: 10% to 15%), bruise (10% to 21%; including petechia) (table 2), hemorrhage (8% to 20%; grades ≥3: ≤2%; major hemorrhage: ≤4%), lymphocytosis (16% to 26%; grades ≥3: 15% to 19%) (table 3), neutropenia (23% to 48%; grades ≥3: 13% to 23%), second primary malignant neoplasm (12%), thrombocytopenia (32% to 33%; grades ≥3: 3% to 6%)

Acalabrutinib: Adverse Reaction: Bruise

Drug (Acalabrutinib)

Comparator (Acalabrutinib plus Obinutuzumab)

Comparator (Obinutuzumab plus Chlorambucil)

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Acalabrutinib plus Obinutuzumab)

Number of Patients (Obinutuzumab plus Chlorambucil)

21%

31%

5%

Chronic lymphocytic leukemia

179

178

169

10%

N/A

N/A

Chronic lymphocytic leukemia

154

N/A

N/A

21%

N/A

N/A

Mantle cell lymphoma

124

N/A

N/A

Acalabrutinib: Adverse Reaction: Hemorrhage

Drug (Acalabrutinib)

Comparator

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Comparator)

Comments

All grades: 20%

Acalabrutinib plus obinutuzumab: 20%

Chronic lymphocytic leukemia

179

178

N/A

All grades: 20%

Obinutuzumab plus chlorambucil: 6%

Chronic lymphocytic leukemia

179

169

N/A

All grades: 16%

Idelalisib plus rituximab product: 5%

Chronic lymphocytic leukemia

154

118

N/A

All grades: 16%

Bendamustine plus rituximab product: 6%

Chronic lymphocytic leukemia

154

35

N/A

Grades ≥3: 2%

Acalabrutinib plus obinutuzumab (grades ≥3): 2%

Chronic lymphocytic leukemia

179

178

N/A

Grades ≥3: 2%

Obinutuzumab plus chlorambucil (grades ≥3): 0%

Chronic lymphocytic leukemia

179

169

N/A

Grades ≥3: 1%

Idelalisib plus rituximab product (grades ≥3): 2%

Chronic lymphocytic leukemia

154

118

N/A

Grades ≥3: 1%

Bendamustine plus rituximab product (grades ≥3): 3%

Chronic lymphocytic leukemia

154

35

N/A

All grades: 8%

N/A

Mantle cell lymphoma

124

N/A

N/A

Grades ≥3: 0.8%

N/A

Mantle cell lymphoma

124

N/A

N/A

Major hemorrhage: 4%

N/A

N/A

1,764

N/A

Serious or grades ≥3 bleeding or any central nervous system bleeding

Hepatic: Increased serum alanine aminotransferase (15% to 20%), increased serum aspartate aminotransferase (13% to 17%), increased serum bilirubin (13% to 15%)

Infection: Infection (56% to 65%; serious infection [including bacterial infection, fungal infection, or viral infection: ≤32%]) (table 4)

Acalabrutinib: Adverse Reaction: Infection

Drug (Acalabrutinib)

Comparator

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Comparator)

Comments

65%

Acalabrutinib plus obinutuzumab: 69%

Chronic lymphocytic leukemia

179

178

N/A

65%

Obinutuzumab plus chlorambucil: 46%

Chronic lymphocytic leukemia

179

169

N/A

56%

Idelalisib plus rituximab product: 65%

Chronic lymphocytic leukemia

154

118

N/A

56%

Bendamustine plus rituximab product: 49%

Chronic lymphocytic leukemia

154

35

N/A

Serious or grades ≥3 infection: 32%

N/A

N/A

1,764

N/A

Bacterial, fungal, or viral infection

Nervous system: Dizziness (12%), fatigue (15% to 28%), headache (22% to 39%)

Neuromuscular & skeletal: Arthralgia (8% to 16%), musculoskeletal pain (15% to 32%), myalgia (21%)

Respiratory: Lower respiratory tract infection (18% to 23%; including pneumonia) (table 5), upper respiratory tract infection (29% to 35%; including sinusitis) (table 6)

Acalabrutinib: Adverse Reaction: Lower Respiratory Tract Infection

Drug (Acalabrutinib)

Comparator

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Comparator)

23%

Idelalisib plus rituximab product: 26%

Chronic lymphocytic leukemia

154

118

23%

Bendamustine plus rituximab product: 14%

Chronic lymphocytic leukemia

154

35

18%

Acalabrutinib plus obinutuzumab: 24%

Chronic lymphocytic leukemia

179

178

18%

Obinutuzumab plus chlorambucil: 7%

Chronic lymphocytic leukemia

179

169

Acalabrutinib: Adverse Reaction: Upper Respiratory Tract Infection

Drug (Acalabrutinib)

Comparator

Indication

Number of Patients (Acalabrutinib)

Number of Patients (Comparator)

35%

Acalabrutinib plus obinutuzumab: 39%

Chronic lymphocytic leukemia

179

178

35%

Obinutuzumab plus chlorambucil: 17%

Chronic lymphocytic leukemia

179

169

29%

Idelalisib plus rituximab product: 26%

Chronic lymphocytic leukemia

154

118

29%

Bendamustine plus rituximab product: 17%

Chronic lymphocytic leukemia

154

35

1% to 10%:

Cardiovascular: Atrial fibrillation (≤5%), atrial flutter (≤5%), hypertension (3%)

Dermatologic: Skin carcinoma (non-melanoma: 6%)

Hematologic & oncologic: Hematologic malignancy (≤1%), lymphocytopenia (grades 3/4: ≤10%), malignant solid tumor (≤9%; including gastrointestinal carcinoma, genitourinary neoplasm, lung carcinoma, malignant melanoma)

Infection: Herpes virus infection (5%), neutropenic infection (≤3%)

Renal: Increased serum creatinine (1% to 5%)

Respiratory: Epistaxis (6%)

Frequency not defined: Infection: Opportunistic infection (including cytomegalovirus disease, reactivation of latent Epstein-Barr virus, pneumonia due to Pneumocystis jirovecii, progressive multifocal leukoencephalopathy)

Postmarketing:

Cardiovascular: Ventricular arrhythmia (Ref)

Hepatic: Hepatotoxicity (including yellow urticaria) (Ref)

Infection: Aspergillosis (Ref), reactivation of HBV (Ref)

Nervous system: Intracranial hemorrhage (Ref)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to acalabrutinib or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Grade 3 or 4 cytopenias including neutropenia, anemia, thrombocytopenia, and lymphopenia have occurred in patients with hematologic malignancies treated with acalabrutinib (as a single agent or in combination with obinutuzumab).

• Cardiovascular adverse effects: Serious and fatal arrhythmias have occurred with acalabrutinib. Atrial fibrillation and atrial flutter (any grade) occurred in a small percentage of patients with hematologic malignancies treated with acalabrutinib; grade 3 and 4 events were reported. Ventricular arrhythmia (≥ grade 3) occurred rarely. The risk of arrhythmia may be increased in patients with cardiac risk factors, hypertension, prior arrhythmia, and acute infection.

• Hemorrhage: Serious hemorrhagic events (some fatal) have been reported in patients treated with acalabrutinib. Major hemorrhages (serious or ≥ grade 3 bleeding or any CNS bleeding) have been reported in a small percentage of patients. Bleeding events of any grade (excluding bruising and petechiae) occurred in almost one-half of patients. Acalabrutinib may further increase the risk of hemorrhage in patients receiving antithrombotic agents (assess risks versus benefits of concomitant therapy). Depending upon the type of surgery and the risk of bleeding, consider the benefit-risk of withholding acalabrutinib treatment for 3 to 7 days before and after surgery.

• Hepatotoxicity: Severe, life-threatening, and potentially fatal hepatotoxicity and drug-induced liver disease have occurred with Bruton tyrosine kinase inhibitors, including acalabrutinib.

• Infection: Serious and fatal infections (including opportunistic infections) have occurred in patients with hematologic malignancies treated with acalabrutinib. Serious or ≥ grade 3 infections (bacterial, viral, or fungal) occurred in about one-third of these patients, most often due to respiratory infections. Infections usually occurred in the absence of grade 3 or 4 neutropenia (neutropenic infection occurred in a small percentage of patients). Opportunistic infections have included (although were not limited to) hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy.

• Secondary malignancies: Second primary malignancies, including skin cancers and other solid tumors, have occurred in patients treated with acalabrutinib; the most frequent second primary malignancy was nonmelanoma skin cancer (protection from sun exposure is recommended), followed by other solid tumors (including melanoma, lung cancer, GI cancers, and genitourinary cancers) and hematologic malignancies.

Special populations:

• Older adults: Patients ≥65 years of age treated with acalabrutinib for chronic lymphocytic leukemia or previously treated mantle cell lymphoma experienced a higher incidence of serious or ≥ grade 3 adverse reactions.

Product Availability

Calquence capsules have been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Calquence: 100 mg [DSC] [contains fd&c blue #2 (indigotine,indigo carmine)]

Tablet, Oral, as maleate:

Calquence: 100 mg

Generic Equivalent Available: US

No

Pricing: US

Tablets (Calquence Oral)

100 mg (per each): $316.58

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Calquence: 100 mg [contains corn starch, fd&c blue #2 (indigotine,indigo carmine)]

Tablet, Oral, as maleate:

Calquence: 100 mg

Prescribing and Access Restrictions

Available through specialty pharmacy distributors. Information regarding distribution is available from the manufacturer at www.calquence.com.

Administration: Adult

Oral: Administer doses ~12 hours apart. May administer with or without food. Swallow whole with water. Do not chew, crush, dissolve, or cut tablets; do not open, break, or chew capsules.

When administered on the same day as obinutuzumab (in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma), administer acalabrutinib prior to obinutuzumab.

Use: Labeled Indications

Chronic lymphocytic leukemia or small lymphocytic lymphoma: Treatment (as a single agent or in combination with obinutuzumab) of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults.

Mantle cell lymphoma:

Treatment (in combination with bendamustine and rituximab) of previously untreated mantle cell lymphoma (MCL) in adults who are ineligible for autologous hematopoietic cell transplantation.

Treatment (as a single agent) of MCL in adults who have received at least 1 prior therapy.

Use: Off-Label: Adult

Waldenström macroglobulinemia

Medication Safety Issues
Sound-alike/look-alike issues:

Acalabrutinib may be confused with abemaciclib, afatinib, alectinib, alpelisib, avapritinib, axitinib, ibrutinib, pirtobrutinib, zanubrutinib.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of BCRP, CYP3A4 (Major), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Agents with Antiplatelet Effects: Acalabrutinib may increase antiplatelet effects of Agents with Antiplatelet Effects. Risk C: Monitor

Antacids: May decrease serum concentration of Acalabrutinib. Management: Separate administration of acalabrutinib capsules from the administration of any antacid by at least 2 hours in order to minimize the potential for a significant interaction. Acalabrutinib tablets are not expected to interact with antacids. Risk D: Consider Therapy Modification

Anticoagulants: Acalabrutinib may increase anticoagulant effects of Anticoagulants. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Acalabrutinib. Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Acalabrutinib. Management: Avoid co-administration of strong CYP3A inducers in patients taking acalabrutinib. If strong CYP3A inducers cannot be avoided, increase the dose of acalabrutinib to 200 mg twice daily. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Acalabrutinib. Management: Reduce acalabrutinib dose to 100 mg once daily with concurrent use of a moderate CYP3A4 inhibitor. Monitor patient closely for both acalabrutinib response and evidence of adverse effects with any concurrent use. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Acalabrutinib. Risk X: Avoid

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Histamine H2 Receptor Antagonists: May decrease serum concentration of Acalabrutinib. Management: Give acalabrutinib capsules 2 hours before a histamine H2 receptor antagonist (H2RA). No action is required if acalabrutinib tablets are coadministered with H2RAs. Risk D: Consider Therapy Modification

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Inhibitors of the Proton Pump (PPIs and PCABs): May decrease serum concentration of Acalabrutinib. This interaction is only applicable to acalabrutinib capsules. Risk X: Avoid

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Therapeutic Antiplatelets: Acalabrutinib may increase antiplatelet effects of Therapeutic Antiplatelets. Risk C: Monitor

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Food Interactions

Administration with a high-fat, high-calorie meal (~918 calories; 59 g carbohydrate; 59 g fat; 39 g protein) results in Cmax decreased by 54% (tablets) or 73% (capsules) and Tmax delayed 1 to 2 hours.

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during therapy and for 1 week after the last acalabrutinib dose.

Pregnancy Considerations

Based on data from animal reproduction studies, in utero exposure to acalabrutinib may cause fetal harm.

Breastfeeding Considerations

It is not known if acalabrutinib is present in breast milk.

Due to the potential for adverse events in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy or for 2 weeks after the final acalabrutinib dose.

Monitoring Parameters

CBC regularly during treatment (was monitored monthly in studies). Monitor bilirubin and transaminases at baseline and periodically during treatment; monitor more frequently in patients with abnormal liver tests or signs/symptoms of hepatic toxicity. Evaluate pregnancy status prior to use in patients who could become pregnant. Monitor for signs/symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea); monitor for signs/symptoms of bleeding (in patients receiving antiplatelet or anticoagulant therapies), infection, and/or secondary malignancies. Monitor adherence.

The American Society of Clinical Oncology hepatitis B screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends hepatitis B virus (HBV) screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Cardiovascular monitoring: Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking (ASCO [Armenian 2017]). Assess BP at baseline and each clinical visit (as well as weekly home monitoring for initial 3 months), obtain ECG at each clinical visit, obtain a baseline echocardiography (transthoracic preferred) in high-risk patients; echocardiography is also recommended in all patients who develop atrial fibrillation (ESC [Lyon 2022]).

Mechanism of Action

Acalabrutinib is a selective and irreversible second-generation Bruton's tyrosine kinase (BTK) inhibitor (Byrd 2016). Acalabrutinib and the active metabolite (ACP-5862) form a covalent bond with a cysteine residue in the active BTK site to inhibit BTK enzyme activity. BTK is an integral component of the B-cell receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signals activation of the pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. BTK inhibition results in decreased malignant B-cell proliferation and tumor growth.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vdss: Acalabrutinib: ~101 L; ACP-5862: ~67 L.

Protein binding: Acalabrutinib: 97.5%; ACP-5862: 98.6%; to human plasma protein.

Metabolism: Hepatic, primarily via CYP3A enzymes, and to a lesser degree by glutathione conjugation and amide hydrolysis; major (active) metabolite: ACP-5862 (geometric mean exposure 2- to 3-fold higher than acalabrutinib, but Bruton's tyrosine kinase inhibition by ACP-5862 is ~50% less potent than that of acalabrutinib).

Bioavailability: 25%; administration with a high-fat, high-calorie meal results in Cmax decreased by 73% and Tmax delayed 1 to 2 hours.

Half-life elimination: Tablets: Acalabrutinib: 1.4 hours; ACP-5862 (active metabolite): 6.4 hours; Capsules: Acalabrutinib: 1 hour; ACP-5862: 3.5 hours.

Time to peak: Tablets: Acalabrutinib: 0.5 hours; ACP-5862: 0.75 hours; Capsules: Acalabrutinib: 0.9 hours; ACP-5862: 1.6 hours.

Excretion: Feces (84%; <2% as unchanged drug); Urine (12%; <2% as unchanged drug).

Clearance: Acalabrutinib: 148 L/hour; ACP-5862: 19 L/hour.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Acalabrutinib exposure (AUC) was increased 1.9-fold in subjects with mild impairment (Child-Turcotte-Pugh class A), 1.5-fold in subjects with moderate impairment (Child-Turcotte-Pugh class B), and 5.3-fold in subjects with severe impairment (Child-Turcotte-Pugh class C), compared to subjects with normal hepatic function.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Calquence;
  • (AR) Argentina: Calquence;
  • (AT) Austria: Calquence;
  • (AU) Australia: Calquence;
  • (BD) Bangladesh: Acalanib;
  • (BE) Belgium: Calquence;
  • (BG) Bulgaria: Calquence;
  • (BR) Brazil: Calquence;
  • (CH) Switzerland: Calquence;
  • (CL) Chile: Calquence;
  • (CO) Colombia: Calquence;
  • (CZ) Czech Republic: Calquence;
  • (DE) Germany: Calquence;
  • (DO) Dominican Republic: Calquence;
  • (EC) Ecuador: Calquence;
  • (EE) Estonia: Calquence;
  • (EG) Egypt: Calquence;
  • (ES) Spain: Calquence;
  • (FI) Finland: Calquence;
  • (FR) France: Calquence;
  • (GB) United Kingdom: Calquence;
  • (HK) Hong Kong: Calquence;
  • (HU) Hungary: Calquence;
  • (ID) Indonesia: Calquence;
  • (IE) Ireland: Calquence;
  • (IN) India: Acabrunat | Acalnib | Acaone | Acaya;
  • (IT) Italy: Calquence;
  • (JO) Jordan: Calquence;
  • (KR) Korea, Republic of: Calquence;
  • (KW) Kuwait: Calquence;
  • (LT) Lithuania: Calquence;
  • (LU) Luxembourg: Calquence;
  • (LV) Latvia: Calquence;
  • (MX) Mexico: Calquence;
  • (MY) Malaysia: Calquence;
  • (NL) Netherlands: Calquence;
  • (NO) Norway: Calquence;
  • (PE) Peru: Calquence;
  • (PL) Poland: Calquence;
  • (PR) Puerto Rico: Calquence;
  • (PT) Portugal: Calquence;
  • (QA) Qatar: Calquence | Calquence Maleate;
  • (RO) Romania: Calquence;
  • (RU) Russian Federation: Calquence;
  • (SE) Sweden: Calquence;
  • (SG) Singapore: Calquence;
  • (SI) Slovenia: Calquence;
  • (SK) Slovakia: Calquence;
  • (TR) Turkey: Calquence;
  • (TW) Taiwan: Calquence;
  • (UY) Uruguay: Calquence;
  • (ZA) South Africa: Calquence
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