Tazemetostat Application Scope

Indicated for the treatment of epithelioid sarcoma (soft tissue sarcoma subtype)
Also approved in some regions for relapsed/refractory follicular lymphoma with EZH2 mutation (not the focus here)

Tazemetostat Characteristics

Ingredients:
- Active: Tazemetostat
- Excipients: Standard pharmaceutical excipients
Properties:
- Oral selective EZH2 inhibitor
- White to off-white film-coated tablets
Packaging Specification:
- 200 mg tablets
- Common package: 240 tablets/bottle
Storage:
- Store at 20–25 °C (room temperature), excursions permitted 15–30 °C
- Keep tightly closed, protect from moisture
Expiry Date: 24 months (bottle unopened)
Executive Standard: Meets FDA / EMA / ICH pharmaceutical quality standards
Approval Number:
- US FDA approval (NDA 213400, 2020)
- EU EMA conditional approval (2020)
Date of Revision: Latest label update: 2024
Manufacturer: Epizyme, Inc. (a subsidiary of Ipsen)

Dosage and Administration:
- Recommended Dose: 800 mg orally twice daily (four × 200 mg tablets)
- Administration: Swallow tablets whole, do not crush or chew
- Missed Dose: If a dose is missed, take the next dose at the regular time; do not double dose
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue
  - Nausea
  - Decreased appetite
  - Abdominal pain
  - Constipation
- Serious Adverse Reactions:
  - Secondary malignancies (e.g., T-cell lymphoblastic lymphoma, MDS/AML)
  - Severe anemia, thrombocytopenia
Contraindications: Known hypersensitivity to Tazemetostat or excipients
Precautions:
- Monitor blood counts regularly
- Embryo-fetal toxicity risk (avoid during pregnancy)
- Consider contraception during treatment and for a period after

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.