Concise Prescribing Info
Mantle cell lymphoma (MCL) in adult patients who have received at least 1 prior therapy. Chronic lymphocytic leukemia (CLL) in adults.
Dosage/Direction for Use
Monotherapy 100 mg approx every 12 hr until disease progression or unacceptable toxicity. In combination w/ obinutuzumab Patient w/ previously untreated CLL 100 mg approx every 12 hr until disease progression or unacceptable toxicity. Start Calquence at cycle 1 (each cycle is 28 days). Start obinutuzumab at cycle 2 for a total of 6 cycles. Administer Calquence prior to obinutuzumab when given on the same day.
Special Precautions
Risk of serious infections, including opportunistic infections; serious hemorrhagic events; cytopenias including neutropenia, anemia, thrombocytopenia & lymphopenia; second primary malignancies including skin cancers & other solid tumors; atrial fibrillation or flutter. Avoid administration in patients w/ severe hepatic impairment. May cause fetal harm & dystocia. Advise pregnant women of the potential risk to a fetus. Advise lactating women not to breastfeed while on treatment & for at least 2 wk after final dose. Elderly.
Adverse Reactions
Anemia, thrombocytopenia, neutropenia; headache; fatigue; bruising, rash; diarrhea, nausea; hemorrhage. MCL: Myalgia; abdominal pain, constipation, vomiting; epistaxis. CLL: Infection, upper or lower resp tract infection, UTI; lymphocytosis; dizziness; musculoskeletal pain, arthralgia; increased uric acid, ALT, AST, or bilirubin.
Drug Interactions
Increased plasma conc w/ strong (eg, itraconazole) or moderate CYP3A inhibitor. Decreased plasma conc w/ strong CYP3A inducers (eg, rifampin); proton pump inhibitor, H2-receptor antagonist, or antacid.
ATC Classification
L01EL02 - acalabrutinib ; Belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors. Used in the treatment of cancer.
Calquence cap 100 mg
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