Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
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.
Treatment with this medicinal product should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
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.
Recommended dose modifications of Calquence for Grade ≥ 3 adverse reactions are provided in Table 1.
Table 1. Recommended dose adjustments for adverse reactions*:
| Adverse reaction | Adverse 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.
Recommendations regarding use of Calquence with CYP3A inhibitors or inducers and gastric acid reducing agents 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 inhibitor | Avoid 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. |
| Gastric acid reducing agents | Proton pump inhibitors | Avoid concomitant use. |
| H2-receptor antagonists | Take Calquence 2 hours before (or 10 hours after) taking a H2-receptor antagonist. | |
| Antacids | The interval between taking the medicinal products should be at least 2 hours. |
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.
No dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.2).
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).
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).
Patients with severe cardiovascular disease were excluded from Calquence clinical studies.
The safety and efficacy of Calquence in children and adolescents aged 0 to 18 years have not been established. No data are available.
Calquence is for oral use. The capsules should be swallowed whole with water at approximately the same time each day, with or without food (see section 4.5). The capsules should not be chewed, dissolved or opened as this may affect the absorption of the medicinal product into the body.
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.
3 years.
This medicinal product does not require any special storage conditions.
Aluminium/Aluminium blisters with sun/moon symbols containing 6 or 8 hard capsules. Cartons of 56 or 60 capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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