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TAZVERIK (tazemetostat) OFFERS ORAL TWICE-DAILY DOSING AND CAN BE TAKEN WITH OR WITHOUT FOOD1

Recommended dose of 800 mg (4 x 200 mg tablets) taken orally, twice daily until disease progression or unacceptable toxicity.1

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 taking TAZVERIK, but continue with the next scheduled dose.1

NDC number (10 digit): 72607-100-00

NDC number (11 digit): 72607-0100-00

How supplied: 240-count bottle

NDC=National Drug Code

Recommended dose reductions for adverse reactions1

Dose Reduction
Dosage
First
Dosage
600 mg twice daily
Second
Dosage
400 mg twice daily*

*Permanently discontinue TAZVERIK in patients who are unable to tolerate 400 mg orally twice daily.

1 of 62

patients required a dose reduction due to decreased appetite1

34%

of patients required dose interruptions due to adverse reactions1

The most frequent adverse reactions requiring dose interruptions in ≥3% of patients were hemorrhage, increased alanine aminotransferase (ALT), and increased aspartate aminotransferase (AST).1

Recommended dose modifications for adverse reactions1

Neutropenia
Severity
Neutrophil count less than 1 x 109/L
Dosage Modification
  • Withhold until neutrophil count is greater than or equal to 1 x 109/L or baseline.
  • For first occurrence, resume at same dose.
  • For second and third occurrence, resume at reduced dose.
  • Permanently discontinue after fourth occurrence.
Thrombocytopenia
Severity
Platelet count less than 50 x 109/L
Doseage Modification
  • Withhold until platelet count is greater than or equal to 75 x 109/L or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Anemia
Severity
Hemoglobin less than 8 g/dL
Dosage Modification
  • Withhold until improvement to at least Grade 1 or baseline, then resume at same or reduced dose.
Other adverse reactions
Severity
Grade 3
Dosage Modification
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Other adverse reactions
Severity
Grade 4
Dosage Modification
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first occurrence, resume at reduced dose.
  • Permanently discontinue after second occurrence.

Recommended dose reductions of TAZVERIK for moderate CYP3A inhibitors1

Current Dosage
Adjusted Dosage
800 mg orally twice daily
400 mg orally twice daily
600 mg orally twice daily
400 mg for the first dose and 200 mg for second dose
400 mg orally twice daily
200 mg orally twice daily
Current Dosage:
800 mg orally twice daily
Adjusted Dosage:
400 mg orally twice daily
Current Dosage:
600 mg orally twice daily
Adjusted Dosage:
400 mg for the first dose and 200 mg for second dose
Current Dosage:
400 mg orally twice daily
Adjusted Dosage:
200 mg orally twice daily

Dose adjustments are not recommended for patients with mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment.1✝︎

Dose adjustments are not recommended for patients with mild to severe renal impairment, including end-stage renal disease.1

†Moderate=total bilirubin > 1.5 to 3 times ULN; severe=total bilirubin > 3 times ULN. 1

CYP3A=Cytochrome P450 (CYP)3A; ULN=upper limit of normal.

 

Reference: 1. TAZVERIK™ (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., June 2020.

Learn more about how safety was evaluated in
the Phase 2 study in epithelioid sarcoma patients.

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 729 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) occurred in 0.7% of patients. One pediatric patient developed T‑cell lymphoblastic lymphoma (T‑LBL). Monitor patients long-term for the development of secondary malignancies.

  • Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, TAZVERIK can cause fetal harm when administered to pregnant women. There are no available data on TAZVERIK use in pregnant women to inform the drug‑associated risk. Administration of tazemetostat to pregnant rats and rabbits during organogenesis resulted in dose‑dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure (area under the plasma concentration time curve [AUC0‑45h]) at the 800 mg twice daily dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAZVERIK and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TAZVERIK and for 3 months after the final dose.

Adverse Reactions

In 62 clinical study patients with epithelioid sarcoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥3% were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress. The most common (≥20%) adverse reactions were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).

Drug Interactions

Avoid coadministration of strong or moderate CYP3A inhibitors with TAZVERIK. If coadministration of moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate and strong CYP3A inducers with TAZVERIK, which may decrease the efficacy of TAZVERIK.

Coadministration of TAZVERIK with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and reduced efficacy of CYP3A substrates.

Lactation

Because of the potential risk for serious adverse reactions from TAZVERIK in the breastfed child, advise women not to breastfeed during treatment with TAZVERIK and for one week after the final dose.

Before prescribing TAZVERIK, please read the full Prescribing Information.