Generic Name and Formulations:
Acalabrutinib 100mg; caps.
Indications for CALQUENCE:
Mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Swallow whole with water. 100mg approx. every 12hrs until disease progression or unacceptable toxicity. Concomitant moderate CYP3A inhibitors: 100mg once daily. Concomitant strong CYP3A inducers: avoid; if needed, increase dose to 200mg twice daily. Dose modifications for adverse reactions: see full labeling.
Risk of hemorrhage; consider the benefit/risk of withholding treatment for 3–7 days pre-and post-surgery. Monitor for infections; consider prophylaxis if at risk for opportunistic infections. Monitor for cytopenias; obtain CBCs monthly. Risk of second primary malignancies (eg, skin cancer or other carcinomas); advise patients to protect from sun exposure. Monitor for atrial fibrillation/flutter; manage appropriately. Pregnancy. Nursing mothers: not recommended (during and for at least 2 weeks after final dose).
Bruton tyrosine kinase (BTK) inhibitor.
Avoid concomitant strong CYP3A inhibitors (eg, itraconazole); if short-term use (eg, anti-infectives for ≤7days), interrupt acalabrutinib therapy. Concomitant moderate CYP3A inhibitors: reduce acalabrutinib dose (see Adult). Avoid concomitant strong CYP3A inducers (eg, rifampin); if unavoidable, increase acalabrutinib dose (see Adult). Increased risk of hemorrhage with concomitant antiplatelets or anticoagulants; monitor. Antagonized by gastric acid reducing agents (eg, PPI [avoid], H2-receptor antagonist, or antacid); if needed, consider ranitidine, famotidine, or calcium carbonate. Separate dosing by at least 2hrs with antacids. Take acalabrutinib 2hrs before H2-receptor antagonist use.
Anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, bruising; hemorrhage, infections, second primary malignancy, atrial fibrillation/flutter.