Revumenib｜Leukaemia｜HongKong DengYue Medicine

Revumenib Application Scope

• Relapsed/refractory acute leukaemia (e.g., KMT2A-rearranged AML, NPM1-mutated AML, and other MLL-dependent cancers).
• Potential use in pediatric and adult populations (ongoing trials).

Characteristics

Ingredients:

• Active: Revumenib (SNDX-5613).
• Inactive: Excipients vary by formulation (typically capsules/tablets; details pending final approval).

Properties:

• Mechanism: Binds menin to disrupt menin-KMT2A interaction, inhibiting oncogenic signaling.
• Solubility: Data pending (oral bioavailability confirmed in trials).

Specification:

• Clinical trial formulations: Dose-ranging.

Packaging Specification:

• Currently limited to clinical trial supplies (blister packs or bottles).

Storage:

• Stable at room temperature (20–25°C); protect from light/humidity (final storage conditions TBD).

Expiry Date:

• Interim stability data supports ≥12–24 months (final expiry pending approval).

Executive Standard:

• Manufactured under GMP (Good Manufacturing Practice) for investigational drugs.

Approval Number:

• IND (Investigational New Drug): Active (e.g., FDA IND 157123).
• Approval: Not yet granted (as of 2024).

Date of Revision:

• Updated per trial phases (latest protocol revisions in 2023–2024).

Manufacturer:

• Syndax Pharmaceuticals (developer).

Guidelines for the Use of Revumenib

Based on clinical trial protocols (e.g., AUGMENT-101 trial):

Dosage and Administration:

• Oral administration: Typically 50–200 mg twice daily (dose-adjusted based on response/toxicities).
• Taken with/without food (final guidance pending).
• Pediatric use: Under investigation (age ≥12 years in trials).

Adverse Reactions:

• Common:
  • Nausea, fatigue, QT prolongation, dysgeusia (metallic taste).
  • Hematologic toxicities (e.g., cytopenias).
• Serious:
  • Differentiation syndrome (similar to other AML therapies).
  • Infections due to myelosuppression.

Contraindications:

• Hypersensitivity to revumenib or excipients.
• Concurrent use with strong CYP3A inducers (risk of reduced efficacy).

Precautions:

• QT prolongation: Monitor ECG and electrolytes (K⁺/Mg²⁺).
• Hepatotoxicity: Regular LFT monitoring.
• Pregnancy: Contraindicated (teratogenic risk; Category D expected).

Revumenib Interactions

Drug Interactions:

• Strong CYP3A inhibitors (e.g., ketoconazole): ↑ Revumenib exposure (dose reduction may be needed).
• Strong CYP3A inducers (e.g., rifampin): ↓ Revumenib efficacy (avoid).
• QT-prolonging agents (e.g., fluoroquinolones): ↑ Risk of arrhythmias.
• Acid-reducing agents: No significant interaction expected (pH-independent absorption).

 

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.