Acalabrutinib requires medical supervision because BTK inhibition can be associated with hematologic, infectious, cardiovascular and hepatic adverse effects.
Serious and opportunistic infections
Patients receiving acalabrutinib can develop serious or opportunistic infections. The current U.S. label advises monitoring for signs and symptoms of infection and treating infections promptly.
Hemorrhage
Bleeding is an established safety concern. Patients should be monitored for bleeding, particularly when other medicines may increase bleeding risk.
Cytopenias
Acalabrutinib can cause decreases in neutrophils, lymphocytes, platelets and hemoglobin. Complete blood counts should be monitored regularly.
Second primary malignancies
Other malignancies, including skin cancers and other solid tumors, have occurred in patients receiving CALQUENCE. Current U.S. labeling advises sun protection.
Cardiac arrhythmias
Cardiac arrhythmias are an identified warning. Patients should report symptoms such as palpitations, dizziness, fainting or other concerning cardiac symptoms to their healthcare professional.
Hepatotoxicity
Acalabrutinib can cause hepatotoxicity, including drug-induced liver injury. Current U.S. labeling recommends monitoring hepatic function throughout treatment.
Drug interactions
Acalabrutinib is substantially affected by CYP3A-modifying drugs. Strong CYP3A inhibitors and inducers should generally be avoided, while certain moderate inhibitors require dosage modification.
Pregnancy
Current U.S. labeling states that acalabrutinib may cause fetal harm. Pregnancy considerations should be discussed with the treating healthcare professional before treatment.
Lactation
The U.S. label advises patients not to breastfeed during CALQUENCE treatment and for the specified period after the final dose.
Surgery and bleeding
Because bleeding is a recognized risk, planned invasive procedures should be discussed with the treating team. Treatment interruption may be considered according to the clinical situation and applicable prescribing information.