TAZVERIK 200 mg/1
tazemetostat · TABLET, FILM COATED · Epizyme, Inc.
TAZVERIK is a tablet, film coated containing tazemetostat at 200 mg/1, taken oral. Manufactured by Epizyme, Inc..
Key Facts
- Brand Name
- TAZVERIK
- Generic Name
- tazemetostat
- NDC Code (Product)
72607-100- Manufacturer
- Epizyme, Inc.
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA211723
- Marketing Start
- 01/23/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 1.1 ) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. ( 1.2 ) Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. ( 1.2 ) These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Epithelioid Sarcoma TAZVERIK is 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. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage is 800 mg taken orally twice daily with or without food. ( 2.2 ) 2.1 Patient Selection Select patients with R/R FL for treatment with TAZVERIK based on the presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens [see Clinical Studies ( 14.2 )] . Information on FDA-approved tests for the detection of EZH2 mutation in relapsed or refractory follicular lymphoma is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage The recommended dosage of TAZVERIK is 800 mg orally twice daily with or without food until disease progression or unacceptable toxicity. Swallow tablets whole. Do not cut, crush, or chew tablets. Do not take an additional dose if a dose is missed or vomiting occurs after TAZVERIK, but continue with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions Table 1 summarizes the recommended dose reductions, and Table 2 summarizes the recommended dosage modifications of TAZVERIK for adverse reactions. Table 1. Recommended Dose Reductions of TAZVERIK for Adverse Reactions *Permanently discontinue TAZVERIK in patients who are unable to tolerate 400 mg orally twice daily. Do…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong or Moderate Cytochrome P450 (CYP)3A Inhibitors : Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. Reduce the dose of TAZVERIK if coadministration of strong or moderate CYP3A inhibitors cannot be avoided. ( 2.3 , 7.1 ) Strong or Moderate CYP3A Inducers : Avoid coadministration with TAZVERIK. ( 7.1 ) 7.1 Effect of Other Drugs on TAZVERIK Strong or Moderate CYP3A Inhibitors Coadministration of TAZVERIK with a strong or moderate CYP3A inhibitor increases tazemetostat plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the frequency or severity of adverse reactions. Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of strong or moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose [see Dosage and Administration ( 2.4 )]. Strong or Moderate CYP3A Inducers Coadministration of TAZVERIK with a strong CYP3A inducer decreases tazemetostat plasma concentrations [see Clinical Pharmacology ( 12.3 )] , and coadministration of TAZVERIK with a moderate CYP3A inducer may also decrease tazemetostat plasma concentrations. The decrease in tazemetostat plasma conce…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Secondary Malignancies [see Warnings and Precautions ( 5.1 )]. The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting, and constipation. ( 6.1 ) The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Epizyme at 855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. Epithelioid Sarcoma The safety of TAZVERIK was evaluated in a cohort (Cohort 5) of Study EZH-202 that enrolled patients with epithelioid sarcoma [see Clinical Studies ( 14.1 )]. Patients received TAZVERIK 800 mg orally twice daily (n=62). Among patients who rece…
Frequently Asked Questions
What is TAZVERIK used for?
TAZVERIK contains tazemetostat. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is TAZVERIK a controlled substance?
TAZVERIK is not classified as a controlled substance by the DEA.
What is the generic name for TAZVERIK?
The generic name for TAZVERIK is tazemetostat. There are no other listed brand versions of tazemetostat.
What is the NDC code for TAZVERIK 200 mg/1?
The NDC (National Drug Code) for TAZVERIK 200 mg/1 is 72607-100, listed by Epizyme, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)