The following summarizes current U.S. CALQUENCE capsule labeling and is not an individualized prescription. The correct regimen depends on indication, treatment combination, organ function, drug interactions and adverse reactions.
Standard U.S. regimen
| Treatment setting | U.S. labeled acalabrutinib regimen |
|---|---|
| Adult MCL after at least one prior therapy | 100 mg orally approximately every 12 hours |
| Adult CLL/SLL | 100 mg orally approximately every 12 hours |
| Previously untreated MCL, ineligible for autologous HSCT | 100 mg orally approximately every 12 hours with bendamustine and rituximab |
Administration
The current capsule labeling instructs patients to swallow the capsule whole with water. CALQUENCE may be taken with or without food. Capsules should not be broken, opened or chewed.
Missed dose
If a CALQUENCE dose is missed by more than three hours, the current U.S. capsule label instructs the patient to skip that dose and take the next dose at its scheduled time. Extra capsules should not be taken to compensate.
CYP3A interactions
Strong CYP3A inhibitors should be avoided. Certain moderate CYP3A inhibitors require a reduced acalabrutinib dosage, while strong CYP3A inducers should be avoided; if a strong inducer cannot be avoided, the prescribing information contains specific instructions.
Toxicity-related modifications
Treatment may need interruption, dose reduction or discontinuation when clinically significant adverse reactions occur. The current label provides specific modification rules for hematologic and non-hematologic toxicities.
Hepatic impairment
Current U.S. labeling advises avoiding CALQUENCE in patients with severe hepatic impairment.
Important jurisdictional limitation
The dosing information above relates to current U.S. CALQUENCE labeling. Local prescribing information may differ.