Calquence Application Scope

Calquence is a Bruton’s tyrosine kinase (BTK) inhibitor used orally for treating certain B‑cell malignancies like mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

calquence

Characteristics

Ingredients: Acalabrutinib

Properties:
- Mechanism: covalently inhibits BTK, disrupting B‑cell receptor signaling
- Appearance: Hard capsule (yellow body, blue cap, 20 mm) marked “ACA 100 mg”
- Also film-coated tablet, orange, debossed “ACA 100”
Packaging Specification:
- Capsules: aluminium/aluminium blisters (6 or 8); cartons of 56 or 60 capsules
- Tablets: film‑coated, oval (7.5 × 13 mm)
Storage: No special conditions needed; follow local regulations for disposal
Expiry Date: Refer to packaging; typical shelf life stated in section 6.3 of SPC
Executive Standard: U.S. FDA approval under the Accelerated Approval Program
Approval Number: NDA (New Drug Application) 210259
Date of Revision:
- EU SPC last revised: 05 Nov 2020
- US label updated: June 2024
Manufacturer:
- AstraZeneca AB, Södertälje, Sweden (EU)
- AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA

Guidelines for the Use of Calquence

Dosage and Administration:
- Recommended dose: 100 mg orally twice daily (~12 hr apart), with or without food
- Use under the supervision of an experienced oncologist until disease progression or toxicity
- Combination regimens follow respective dosing schedules in trials

Adverse Reactions:
- Common (≥ 30%):
  - diarrhea, headache, anemia, neutropenia
  - thrombocytopenia, upper RTI, musculoskeletal pain
- Serious:
  - infections, hemorrhage, cytopenias, arrhythmias (atrial fibrillation)
  - hepatotoxicity, second primary malignancies
Contraindications:
- Hypersensitivity to acalabrutinib or any excipient
- No other absolute contraindications are listed
Precautions:
- Monitor for bleeding, infections, cytopenias, cardiac arrhythmias, and secondary malignancies
- Avoid strong CYP3A inhibitors/inducers
- Adjust the dose when moderate CYP3A inhibitors are used
- Use sun protection and monitor skin cancers
- Avoid in severe hepatic impairment
- Use contraception during and for 1 week (female) or 2 weeks of lactation

Calquence Interactions

Drug Interactions:
- Strong CYP3A inhibitors: avoid or interrupt Calquence
- Moderate inhibitors: reduce to 100 mg once daily
- Strong inducers: avoid or increase to 200 mg twice daily

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.