For U.S. Healthcare Professionals Only

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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

TAZVERIK® OFFERS ORAL,
TWICE-DAILY DOSING

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

Tazverik_Bottle_R-ball

NDC number (10 digit): 72607-100-00

NDC number (11 digit): 72607-0100-00

How supplied: 240-count bottle

NDC=National Drug Code

taking-taz-withFood taking-taz-withFood-mobile

1st dose

dose-Tazverik_Pills_Square

Tablets are not
actual size.

2nd dose

dose-Tazverik_Pills_Square

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

TAZVERIK is an oral therapy that works through an epigenetic mechanism. It may take time for your patients to respond to TAZVERIK.1,2

  • For patients who experienced an overall response in the clinical trial, the median time to response was:

3.9 months (range: 1.6 to 16.3) for patients with WT EZH2.1

and

3.7 months (range: 1.6 to 10.9)
for patients with MT EZH2.1

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

1st dose

dosing 4 tablet mobile

Tablets are not actual size.

2nd dose

dosing 4 tablet mobile

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

TAZVERIK® is an oral therapy that works through an epigenetic mechanism.

It may take time for your patients to respond to TAZVERIK.1,2

For patients who experienced an overall response in the clinical trial, the median time to response was:

3.9 months (range: 1.6 to 16.3) for patients with WT EZH2.1

and

3.7 months (range: 1.6 to 10.9) for patients with MT EZH2.1

WT=wild type; EZH2=enhancer of zeste homolog 2; MT= mutant type.

References: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020. 2. Sermer D, Pasqualucci L, Wendel HG, et al. Emerging epigenetic-modulating therapies in lymphoma. Nat Rev Clin Oncol. 2019;16(8):494-507.

Learn more about overall
response rate observed in the
clinical trial.

CLINICAL TRIAL RESULTS

View guidance on dose
reductions & modifications for
patients taking TAZVERIK.

DOSE MODIFICATIONS

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 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 99 clinical study patients with relapsed or refractory follicular lymphoma receiving TAZVERIK 800 mg twice daily: Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia. The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).

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.

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.

INDICATIONS

TAZVERIK is indicated for the treatment of:

  • 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.
  • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

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).

Please see full Prescribing Information.

 

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TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company.
IPSEN CARES is a registered trademark of Ipsen S.A.
All other trademarks and registered trademarks are property of their respective owners.

TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company. IPSEN CARES is a registered trademark of Ipsen S.A. All other trademarks and registered trademarks are property of their respective owners.

TAZVERIK is a registered trademark of Epizyme, Inc, an Ipsen company.

IPSEN CARES is a registered trademark of Ipsen S.A.

All other trademarks and registered trademarks are property of their respective owners.

©2023 Ipsen Biopharmaceuticals, Inc. All rights reserved. TAZ-US-000086 05/23

©2023 Ipsen Biopharmaceuticals, Inc. All rights reserved. TAZ-US-000086 05/23