- Indications and Usage Mantle Cell Lymphoma (MCL): Indicated for the treatment of adult patients with relapsed or refractory MCL who have received at least one prior therapy. Chronic Lymphocytic Leukemia (CLL) / SLL: Indicated for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.
- Dosage and Administration Recommended Dosage: 100 mg taken orally twice daily, at approximately the same time each day. Administration: The tablets should be swallowed whole and can be taken with or without food. Do not break, chew, or swallow crushed tablets. Dose Modifications: For adverse reactions, may be interrupted, delayed, or reduced to 75 mg twice daily, and further to 50 mg twice daily. Missed Dose: Take as soon as possible on the same day. Do not take if it is within 12 hours of the next scheduled dose; do not double doses.
- Mechanism of Action Irreversible BTK Inhibition: Acalabrutinib is a potent, selective, and irreversible inhibitor of Bruton’s tyrosine kinase (BTK). B-cell Receptor Signaling: By covalently binding to a cysteine residue in the ATP-binding site of BTK, it inhibits B-cell receptor signaling, thereby blocking the proliferation, survival, and migration of B-cell malignancies.
- Safety and Warnings Bleeding/Hemorrhage: Increased risk of bleeding and hemorrhage. Monitor for signs of bleeding and manage anticoagulants/antiplatelets carefully. Arrhythmias: Atrial fibrillation and atrial flutter have been reported. Monitor cardiac rhythm, especially in patients with cardiac risk factors. Infections: Serious and opportunistic infections may occur. Monitor for signs of infection and manage temporarily interrupted if severe. Second Primary Malignancies: Second primary malignancies, including skin cancer and non-melanoma skin cancer, have been reported. Advise sun protection.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Infections (65%), anemia (53%), thrombocytopenia (32%), muscle and bone pain (32%), diarrhea (35%), headache (39%), and fatigue (23%). Clinical Research: Clinical trials (e.g., ACE-LY-303) have demonstrated high overall response rates and durable responses in previously treated MCL and CLL/SLL populations.
- Drug Interactions CYP3A Inhibitors: Strong CYP3A inhibitors (e.g., ketoconazole) can increase exposure. Moderate inhibitors (e.g., erythromycin) may require dose reduction. CYP3A Inducers: Strong CYP3A inducers (e.g., rifampin) significantly decrease exposure and should be avoided. P-gp/BCRP Substrates: Acalabrutinib may increase plasma concentrations of sensitive P-gp/BCRP substrates. Antacids: Intake of proton pump inhibitors (PPIs) should be avoided. H2 antagonists and antacids should be timed (taken at least 2 hours before or after ACALABRUTINIB).
- Pharmaceutical Information Chemical Composition: Active ingredient: Acalabrutinib (as Maleate). Appearance: Pink to off-white, oval, film-coated tablets. Storage: Store at 25°C (77°F); excursions permitted between 15°C-30°C (59°F-86°F). Keep in original containers to protect from moisture and light.
Kekeqi Acalabrutinib Maleate Film-coated Tablets
Brand Name:康可期 ®（Kekeqi®）
Generic Name: Acalabrutinib Maleate
Strength: 100 mg per tablet, 8 tablets per blister, 7 blisters per box (56 tablets total)
Manufacturer: AstraZeneca AB
Marketing Authorization Holder: AstraZeneca Pty Ltd
Approval Date in China: April 11, 2024
Registration Number: 国药准字HJ20240118
Storage: No special storage requirements; store at room temperature, tightly sealed and protected from light and moisture. Refer to the full package insert for detailed storage specifications.
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