The complete official prescribing information should always be consulted for authoritative instructions. The following is a structured summary of current U.S. CALQUENCE capsule labeling and does not replace the official FDA label.
Indications
Current U.S. labeling identifies CALQUENCE for:
- previously untreated adult MCL ineligible for autologous HSCT, in combination with bendamustine and rituximab;
- adult MCL after at least one prior therapy; and
- adult CLL or SLL.
Dosage
The recommended U.S. dose is 100 mg orally approximately every 12 hours. Dose modifications may be required for certain drug interactions and adverse reactions.
Dosage form
Current U.S. capsule labeling identifies a 100 mg acalabrutinib capsule.
Contraindications
The current U.S. label lists no contraindications. This does not mean acalabrutinib is appropriate for every patient; warnings and precautions remain clinically important.
Major warnings and precautions
The label addresses:
- serious and opportunistic infections,
- hemorrhage,
- cytopenias,
- second primary malignancies,
- cardiac arrhythmias, and
- hepatotoxicity, including drug-induced liver injury.
Drug interactions
Strong CYP3A inhibitors and strong CYP3A inducers should generally be avoided. Dosage modification is required with certain moderate CYP3A inhibitors.
Special populations
The current label advises avoiding CALQUENCE in severe hepatic impairment. It also contains pregnancy and lactation warnings.
Complete authoritative document
Readers should consult the latest applicable FDA, EMA or national prescribing information for the complete regulatory document.