Brand Name

Tazverik

Generic Name
Tazemetostat
View Brand Information
FDA approval date: January 23, 2020
Classification: Methyltransferase Inhibitor
Form: Tablet

What is Tazverik (Tazemetostat)?

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
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Brand Information

TAZVERIK (tazemetostat)
1DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg film-coated, red, round, biconvex shape and debossed with "EZM 200" on one side and plain on the other.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
  • Secondary Malignancies
3.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4DESCRIPTION
Tazemetostat is a methyltransferase inhibitor. Tazemetostat hydrobromide has the following chemical name: [1,1'-Biphenyl]-3-carboxamide,
Structural Formula
Tazemetostat hydrobromide is a white to off-white solid that is slightly soluble in water and has pKa values of 5.26, 6.88, and 12.62. A saturated aqueous solution of tazemetostat hydrobromide has a pH of approximately 5 at ambient conditions.
TAZVERIK (tazemetostat) tablets for oral use contain 200 mg tazemetostat, equivalent to 228 mg tazemetostat hydrobromide.
Each tablet is film-coated and contains the following inactive ingredients in the tablet core: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, and sodium starch glycolate. The film-coat contains hypromellose, polyethylene glycol, red iron oxide, talc, and titanium dioxide.
5REFERENCES
  1. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma.
6HOW SUPPLIED/STORAGE AND HANDLING
TAZVERIK 200 mg film-coated tablets are red, round, biconvex shape and debossed with "EZM 200" on one side and plain on the other. TAZVERIK is available in:
Bottles of 240 tablets with a desiccant; NDC 72607-100-00
Do not store above 30°C (86°F).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
8Principal Display Panel - 200 mg Bottle Label
NDC 72607-100-00
240 Tablets
TAZVERIK
200 mg
Rx only
Dispense the Medication Guide, attached or
Epizyme
Principal Display Panel - 200 mg Bottle Label