CALQUENCE Film-coated tablet Ref.[51594] Active ingredients: Acalabrutinib

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

4.1. Therapeutic indications

Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

4.2. Posology and method of administration

Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Posology

The recommended dose is 100 mg acalabrutinib twice daily (equivalent to a total daily dose of 200 mg). Refer to obinutuzumab prescribing information for recommended obinutuzumab dosing information.

The dose interval is approximately 12 hours.

Treatment with Calquence should be continued until disease progression or unacceptable toxicity.

Dose adjustments

Adverse reactions

Recommended dose modifications of Calquence for Grade ≥ 3 adverse reactions are provided in Table 1.

Table 1. Recommended dose adjustments for adverse reactions*:

Adverse reactionAdverse
reaction
occurrence
Dose modification
(Starting dose = 100mg approximately every
12 hours)
Grade 3 thrombocytopenia
with bleeding,
Grade 4 thrombocytopenia
Or
Grade 4 neutropenia lasting
longer than 7 days
Grade 3 or greater non-
haematological toxicities
First and second Interrupt Calquence
Once toxicity has resolved to Grade 1 or
baseline, Calquence may be resumed at 100mg
approximately every 12 hours
Third Interrupt Calquence
Once toxicity has resolved to Grade 1 or
baseline, Calquence may be resumed at a reduced
frequency of 100mg once daily
Fourth Discontinue Calquence

* Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Interactions

Recommendations regarding use of Calquence with CYP3A inhibitors or inducers are provided in Table 2 (see section 4.5).

Table 2. Use with CYP3A inhibitors or inducers and gastric acid reducing agents:

Co-administered
medicinal product
Recommended Calquence use
CYP3A
inhibitors
Strong CYP3A inhibitorAvoid concomitant use.
If these inhibitors will be used short-term (such as
anti-infectives for up to seven days), interrupt Calquence.
Moderate CYP3A
inhibitor
No dose adjustment. Monitor patients closely for adverse
reactions if taking moderate CYP3A inhibitors.
Mild CYP3A inhibitor No dose adjustment.
CYP3A
inducers
Strong CYP3A inducer Avoid concomitant use.

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 section 4.5).

Missed dose

If a patient misses a dose of Calquence by more than 3 hours, the patient should be instructed to take the next dose at its regularly scheduled time. Double dose of Calquence should not be taken to make up for a missed dose.

Special populations

Elderly

No dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2).

Renal impairment

No specific clinical studies have been conducted in patients with renal impairment. Patients with mild or moderate renal impairment were treated in Calquence clinical studies. No dose adjustment is needed for patients with mild or moderate renal impairment (greater than 30 mL/min creatinine clearance). Hydration should be maintained, and serum creatinine levels monitored periodically. Calquence should be administered to patients with severe renal impairment (<30mL/min creatinine clearance) only if the benefit outweighs the risk and these patients should be monitored closely for signs of toxicity. There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).

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). However, patients with moderate hepatic impairment should be closely monitored for signs of toxicity. It is not recommended to use Calquence in patients with severe hepatic impairment (Child-Pugh C or total bilirubin >3-times ULN and any AST) (see section 5.2).

Severe cardiac disease

Patients with severe cardiovascular disease were excluded from Calquence clinical studies.

Paediatric population

The safety and efficacy of Calquence in children and adolescents aged 0 to 18 years have not been established. No data are available.

Method of administration

Calquence is for oral use. The tablets should be swallowed whole with water at approximately the same time each day, with or without food (see section 4.5). The tablets should not be chewed, crushed, dissolved or divided.

4.9. Overdose

There is no specific treatment for acalabrutinib overdose and symptoms of overdose have not been established. In the event of an overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Aluminium/Aluminium blister packs with sun/moon symbols containing 8 or 10 film-coated tablets. Cartons of 56 or 60 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.