Abbreviated Prescribing Information
Calquence

Presentation:

Acalabrutinib capsule 100 mg. Indications: For the treatment of adult patients with: • Mantle cell lymphoma (MCL) who have received at least one prior therapy • Chronic lymphocytic leukemia (CLL). Dosage: 100 mg orally approximately every 12 hours, swallow whole with water and with or without food. Contraindications: None. Precautions: Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat promptly; Monitor patients for signs of bleeding. Consider the benefit-risk of withholding for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding; Monitor complete blood counts regularly; Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection; Monitor for symptoms of arrhythmias and manage; Avoid in patients with severe hepatic impairment; May cause fetal harm and dystocia in pregnancy; Advise not to breastfeed while taking and for at least 2 weeks after the final dose. Interactions: Avoid co-administration with strong CYP3A inhibitors, strong CYP3A inducers and proton pump inhibitors. Dose adjustments may be recommended; Stagger dosing with H2-receptor antagonists and antacids. Undesirable effects: Anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Full local prescribing information is available upon request. API.HK.CAL.0620

HK-10000 19/02/2024