Ascentage Lisaftoclax Application Scope

Investigational use for hematologic malignancies, notably Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), both as monotherapy and in combination with Bruton’s tyrosine kinase inhibitors (BTKis) for relapsed/refractory disease.

Ascentage Lisaftoclax Characteristics

Ingredients: Lisaftoclax
Properties: Oral small-molecule tablet (BCL-2 inhibitor)
Packaging Specification: Available in tablet form. Strengths mentioned include 10 mg, 50 mg, and 200 mg tablets.
Storage: Store tablets at room temperature. For powder form (research grade): -20°C for 3 years; in solvent: -80°C for 1 year
Expiry Date: The expiration date is printed on the packaging.
Executive Standard: Manufactured under appropriate Good Manufacturing Practice (GMP) standards
Approval Number: China’s NMPA on July 10, 2025
Date of Revision: See official Chinese package insert.
Manufacturer: Ascentage Pharma

Guidelines for the Use of Ascentage Lisaftoclax

Dosage and Administration:
- Recommended Dose: The approved dosage for R/R CLL/SLL involves a daily ramp-up schedule over 4-6 days to reach the target maintenance dose, which is designed to minimize the risk of Tumor Lysis Syndrome (TLS) .
- Administration: The tablets are taken orally, once daily . They should be taken at approximately the same time each day, with water, and can be taken with or without food, unless otherwise directed by the doctor.
- Missed Dose: If a dose is missed, take it as soon as remembered on the same day. If it is near the time for the next dose, skip the missed dose and resume the usual schedule. Do not take a double dose to make up for a missed one.
Adverse Reactions:
- Common Adverse Reactions: Transient cytopenias (e.g., neutropenia), gastrointestinal events; overall favorable tolerability
- Serious Adverse Reactions: Clinical TLS was rare (~1% in reports) with monitoring and ramp-up; other SAEs per study reports
Contraindications:
- Hypersensitivity to Lisaftoclax or any excipients in the product.
- Not recommended during pregnancy and breastfeeding unless the potential benefit justifies the potential risk to the fetus or infant.
Precautions:
- Hematologic Toxicity: Monitor complete blood counts regularly throughout treatment. Neutropenia and thrombocytopenia may require dose interruptions, reductions, or supportive care (e.g., growth factors, transfusions).
- Infections: Monitor for signs and symptoms of infection, especially during periods of neutropenia.

Ascentage Interactions

Frequently combined with BTK inhibitors (e.g., acalabrutinib) or rituximab in trials with high response rates; follow label and study-specific monitoring when combining therapies.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.