Acaluxen is identified for this website as a product containing 100 mg of acalabrutinib. Product-specific manufacturer and regulatory information require verification.
Acalabrutinib is an oral BTK inhibitor used in selected adult B-cell malignancies.
Current U.S. labeling covers adult CLL/SLL and specified MCL treatment settings. European authorization includes specified CLL and MCL indications.
Acalabrutinib inhibits Bruton tyrosine kinase, interfering with B-cell receptor signaling involved in malignant B-cell survival and proliferation.
The current U.S. CALQUENCE capsule dose is 100 mg orally approximately every 12 hours for the approved indications, subject to treatment-specific modifications.
Yes. Current U.S. capsule labeling permits CALQUENCE to be taken with or without food.
Capsules should be swallowed whole with water and should not be opened, broken or chewed.
Under current U.S. capsule labeling, if the missed dose is more than three hours late, it should be skipped and the next dose taken at the scheduled time. Extra doses should not be taken.
Common reactions include diarrhea, upper respiratory infection, headache, musculoskeletal pain, lower respiratory infection and fatigue.
Yes. Hemorrhage is an important warning associated with acalabrutinib.
Yes. Serious and opportunistic infections have been reported, and patients should be monitored for infection.
Yes. Cytopenias can occur, including reductions in neutrophils, lymphocytes, platelets and hemoglobin.
Cardiac arrhythmias are an identified warning. Patients should report concerning cardiac symptoms promptly.
Yes. Hepatotoxicity, including drug-induced liver injury, is a recognized warning, and hepatic function should be monitored.
Yes. CYP3A inhibitors and inducers can significantly affect acalabrutinib exposure, and specific dosage adjustments or avoidance are required.
Acalabrutinib was developed by Acerta Pharma, with AstraZeneca acquiring a majority stake in Acerta in 2016.
CALQUENCE is the established branded acalabrutinib product in major regulatory markets.
That should not be assumed. Products may share the same active ingredient while differing in manufacturer, formulation, authorization, packaging and excipients.
Acalabrutinib may cause fetal harm. Pregnancy-related treatment decisions should be handled by an appropriate healthcare professional.
The current U.S. label advises patients not to breastfeed during CALQUENCE treatment and for the specified post-treatment period.
Yes. Monitoring can include complete blood counts, infection symptoms, bleeding, cardiac symptoms and hepatic function.