For U.S. Healthcare Professionals Only

FOR U.S. HEALTHCARE PROFESSIONALS ONLY

TAZVERIK® DOSING AND ADMINISTRATION

Recommended dose Recommended dose

Recommended dose of 800 mg (4 x 200 mg tablets) taken orally, twice daily until disease progression or unacceptable toxicity1

Recommended dose Recommended dose

*Tablets not actual size

Tazverik Swallow tablets Tazverik Swallow tablets

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

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 of TAZVERIK for adverse reactions1

DOSE DOSAGE
First  600 mg twice daily
Second 400 mg twice daily*
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

Recommended dosage modifications of TAZVERIK for adverse reactions1

ADVERSE REACTION & SEVERITY DOSAGE MODIFICATION
Neutropenia
Neutrophil count less than 
1 x 109/L
  • 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
Platelet count less than 
50 x 109/L
  • 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
Hemoglobin less than 8 g/dL
  • Withhold until improvement to at least Grade 1 or baseline, then resume at same or reduced dose.
Other adverse reactions
Grade 3
  • 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
Grade 4
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first occurrence, resume at reduced dose.
  • Permanently discontinue after second occurrence.

Review the Select Lab Abnormalities table when considering dose 

modifications for adverse reactions

Recommended dose reductions of TAZVERIK for moderate CYP3A inhibitors where coadministration cannot be avoided1

CURRENT DOSAGE ADJUSTED DOSAGE
800 mg orally twice daily   400 mg orally twice daily
600 mg orally twice daily 400 mg for 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 first dose and 200 mg for second dose
Current Dosage: 400 mg orally twice daily

Adjusted Dosage:

200 mg orally twice daily
NO DOSE ADJUSTMENTS ARE RECOMMENDED FOR PATIENTS WITH:
•

Mild to severe renal impairment, including end-stage renal disease1
•

Mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment1†

†Mild=total bilirubin > 1 to 1.5 times ULN or AST > ULN; moderate=total bilirubin > 1.5 to 3 times ULN; severe=total bilirubin > 3 times ULN.1

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

Reference: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., December 2023.

Learn more about how safety and

tolerability were evaluated in the clinical trial.

SAFETY & TOLERABILITY

Learn about the resources available through Ipsen Cares. Terms and conditions apply.

IPSEN CARES

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Warnings and Precautions

  • Secondary Malignancies

The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across clinical trials of 758 adults who received TAZVERIK 800 mg twice daily as monotherapy, myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or B-cell acute lymphoblastic leukemia (B-ALL) occurred in 1.7% 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 strong or moderate CYP3A inhibitors cannot be avoided, reduce TAZVERIK dose.

Avoid coadministration of moderate or 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.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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).

Please see full Prescribing Information.