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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Related Clinical Trials

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Summary: This phase I trial tests the safety, side effects, and best dose of tazemetostat in combination with topotecan and pembrolizumab in treating patients with small cell lung cancer that has come back after a period of improvement (recurrent). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as topotecan, work in different...

Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma

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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