Acalabrutinib
CALQUENCE
What it isSecond-generation BTK inhibitor; CLL and mantle cell lymphoma.
Why this oneMore selective than ibrutinib, so less atrial fibrillation, bleeding and hypertension.
What limits itHeadache early is common. Acid-reducing drugs lower absorption of the original capsule.
FDA-approved for
- mantle cell lymphoma (2017)
- chronic lymphocytic leukemia
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| MCL, CLL, or SLL (monotherapy or combination regimens) | adult | 100 mg BID (q12h) | 100 mg BID (q12h) | 100 mg BID (q12h) |
Renal Undefined
Hepatic Avoid in severe hepatic impairment; not evaluated in moderate or severe impairment.
If a dose is missed by more than 3 hours, skip it and take the next dose at the scheduled time; do not take extra capsules.
Instructions
- Swallow capsules whole with water; do not open, break, or chew.
- Take with or without food, approximately every 12 hours.
- Hold for 3–7 days before and after surgery depending on bleeding risk.
Cautions
- Serious and opportunistic infections (including fatal; HBV reactivation, PJP, PML)
- Hemorrhage (fatal and serious; increased with antithrombotics)
- Cytopenias (Grade 3/4 neutropenia, lymphopenia, anemia, thrombocytopenia)
- Second primary malignancies (skin and other solid tumors) — advise sun protection
- Cardiac arrhythmias (atrial fibrillation/flutter, ventricular arrhythmias)
- Hepatotoxicity, including drug-induced liver injury
Adverse reactions
- Most common (≥30%): upper respiratory tract infection, diarrhea, headache, musculoskeletal pain
- Common Grade 3/4 labs (≥10%): neutrophil count decreased, uric acid increased, lymphocyte count decreased, platelets decreased
Pregnancy May cause fetal harm and dystocia (animal data); advise effective contraception during treatment and for 1 week after the last dose.
Lactation Advise not to breastfeed during treatment and for at least 2 weeks after the final dose.
NO BOXED WARNINGS
Principal riskHeadache early; bleeding
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entry2036 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Acalabrutinib ballicule
