Calquence Dosage/Direction for Use

Treatment with CALQUENCE should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology: MCL: The recommended dose of CALQUENCE in monotherapy or in combination with other medicinal products is 100 mg (1 tablet) twice daily. For the combination regimens, refer to the prescribing information of each of the medicinal product for dosing information. For details of the combination regimens, see Pharmacology: Pharmacodynamics under Actions.
CALQUENCE in combination with bendamustine and rituximab: CALQUENCE should be administered on Day 1 on Cycle 1 (each cycle is 28 days) until disease progression or unacceptable toxicity. Bendamustine should be administered at 90 mg/m² on Days 1 and 2 of each cycle for a total of 6 cycles. Rituximab should be administered at 375 mg/m² on Day 1 each cycle for a total of 6 cycles. Patients achieving a response (partial response [PR] or complete response [CR]) after the first 6 cycles, may receive maintenance rituximab at 375 mg/m² on Day 1 of every other cycle for a maximum of 12 additional doses, starting on Cycle 8 up to Cycle 30.
CLL/SLL: The recommended dose of CALQUENCE for the treatment of CLL/SLL is 100 mg (1 tablet) twice daily, either as monotherapy or in combination. Refer to the prescribing information of each of the combination medicinal products for recommended dosing information (for details of the combination regimen, see Pharmacology: Pharmacodynamics under Actions).
CALQUENCE doses should be separated by approximately 12 hours.
Treatment with CALQUENCE monotherapy or in combination with obinutuzumab should continue until disease progression or unacceptable toxicity. Treatment with CALQUENCE in combination with venetoclax with or without obinutuzumab, should continue until disease progression, unacceptable toxicity or completion of 14 cycles of treatment (each cycle is 28 days).
Missed Dose: If a patient misses a dose of CALQUENCE by more than 3 hours, instruct the patient to take the next dose at its regularly scheduled time. Extra tablets of CALQUENCE should not be taken to make up for a missed dose.
Dose Adjustments: Adverse Reactions: Recommended dose modifications of CALQUENCE for Grade ≥3 adverse reactions in patients receiving CALQUENCE monotherapy and CALQUENCE in combination with obinutuzumab or in combination with venetoclax with or without obinutuzumab are provided in Table 13.
Temporarily interrupt CALQUENCE to manage a Grade ≥3 non-haematological treatment-related adverse reaction, Grade 3 thrombocytopenia with significant bleeding, Grade 4 thrombocytopenia, or Grade 4 neutropenia lasting longer than 7 days. Upon resolution of the adverse reaction to Grade 1 or baseline (recovery), restart CALQUENCE as recommended in Table 13. (See Table 13.)

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Dose modifications for adverse reactions in patients receiving CALQUENCE in combination with bendamustine and rituximab are listed in Table 14. (See Table 14.)

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Refer to the prescribing information of each of the medicinal products used in combination with CALQUENCE for additional information for management of toxicities. (See Table 15.)

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Acalabrutinib tablets can be co-administered with gastric acid reducing agents (proton pump inhibitors, H2-receptor antagonists, antacids), unlike acalabrutinib capsules which show impaired uptake when given with acid reducing agents (see Interactions).
Method of Administration: CALQUENCE should be swallowed whole with water at approximately the same time each day. CALQUENCE can be taken with or without food. The tablet should not be chewed, dissolved, or opened.
Special patient populations: Elderly (≥65 years): No dose adjustment is necessary based on age (see Pharmacology: Pharmacokinetics under Actions).
Renal Impairment: No dose adjustment is recommended in patients with mild to moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73m² as estimated by MDRD (modification of diet in renal disease equation)). The pharmacokinetics and safety of CALQUENCE in patients with severe renal impairment (eGFR less than 29 mL/min/1.73m²) or end-stage renal disease have not been studied (see Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment (Child-Pugh A, Child-Pugh B, or total bilirubin between 1.5-3 times the upper limit of normal [ULN] and any AST). Avoid administration of CALQUENCE in patients with severe hepatic impairment (Child-Pugh C or total bilirubin >3 times ULN and any AST) (see Pharmacology: Pharmacokinetics under Actions).
Severe Cardiac Disease: Patients with severe cardiovascular disease were excluded from CALQUENCE clinical studies.
Paediatric and adolescents: The safety and efficacy of CALQUENCE in children and adolescents aged less than 18 years have not been established.