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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

TAZVERIK® Safety Data1

2 percentage

2% of patients, 1/62, required permanent discontinuation of treatment due to an adverse reaction of altered mood.1

2 percentage

2% of patients, 1/62, required a dose reduction due to decreased appetite.1

34 percentage

34% of patients required dose interruptions due to adverse reactions.

 

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

Serious adverse reactions occurred in 37% of patients who received TAZVERIK®. Serious adverse reactions in ≥3% of patients who received TAZVERIK were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress.1

The most common adverse reactions (≥20%) were pain (52%), fatigue (47%), nausea (36%), decreased appetite (26%), vomiting (24%), and constipation (21%).1

ALT=alanine aminotransferase; AST=aspartate aminotransferase.

Adverse Reactions (≥10%) in Patients with Epithelioid Sarcoma Treated with TAZVERIK (N=62)1

ADVERSE REACTIONS ALL GRADES (%) GRADE 3 OR 4 (%)
General    
Paina 52 7
Fatigueb 47 1.6
Gastrointestinal    
Nausea 36 0
Vomiting 24 0
Constipation 21 0
Diarrhea 16 0
Abdominal painc 13 1.6
Metabolism and nutrition    
Decreased appetite 26 4.8
Respiratory, thoracic and mediastinal    
Cough 18 0
Dyspnead 16 4.8
Vascular    
Hemorrhagee 18 4.8
Nervous system    
Headache 18 0
Investigations    
Weight decreased 16 7

General
Paina

All Grades (%):52

Grade 3 or 4 (%):7
Fatigueb

All Grades (%):47

Grade 3 or 4 (%):1.6

Gastrointestinal
Nausea

All grades (%):36

Grade 3 or 4 (%):0
Vomiting

All grades (%):24

Grade 3 or 4 (%):0
Constipation

All grades (%):21

Grade 3 or 4 (%):0
Diarrhea

All grades (%):16

Grade 3 or 4 (%):0
Abdominal painc

All grades (%):13

Grade 3 or 4 (%):1.6

Metabolism and nutrition
Decreased appetite

All grades (%):26

Grade 3 or 4 (%):4.8

Respiratory, thoracic and mediastinal
Cough

All grades (%):18

Grade 3 or 4 (%):0
Dyspnead

All grades (%):16

Grade 3 or 4 (%):4.8

Vascular
Hemorrhagee

All grades (%):18

Grade 3 or 4 (%):4.8

Nervous system
Headache

All grades (%):18

Grade 3 or 4 (%):0

Investigations
Weight decreased

All grades (%):16

Grade 3 or 4 (%):7
  1. Includes tumor pain, pain in extremity, non-cardiac chest pain, flank pain, back pain, arthralgia, bone pain, cancer pain, musculoskeletal pain, myalgia, neck pain1
  2. Includes fatigue and asthenia1
  3. Includes abdominal pain, gastrointestinal pain, abdominal pain lower1
  4. Includes dyspnea and dyspnea exertional1
  5. Includes wound hemorrhage, rectal hemorrhage, pulmonary hemorrhage, hemorrhage intracranial, cerebral hemorrhage, hemoptysis1

Select Laboratory Abnormalities (≥10%) Worsening From Baseline in Patients With Epithelioid Sarcoma Treated With TAZVERIK1

LABORATORY ABNORMALITY TAZVERIK*
ALL GRADES (%) GRADE 3 OR 4 (%)
Hematology    
Decreased hemoglobin 49 15
Decreased lymphocytes 36 13
Decreased white blood cell count 19 0
Chemistry    
Increased triglycerides 36 3.3
Increased glucose 33 1.6
Decreased sodium 30 1.7
Decreased phosphate 28 1.7
Decreased albumin 23 0
Increased alkaline phosphatase 23 1.7
Decreased potassium 20 1.7
Increased aspartate aminotransferase 18 3.5
Decreased  calcium 16 0
Decreased glucose 16 0
Increased partial thromboplastin time 15 5
Increased alanine aminotransferase 14 3.4
Increased creatinine 12 0
Increased potassium 12 0

*The denominator used to calculate the rate varied from 39 to 61 based on the number of patients with a baseline value and at least one post-treatment value.

TAZVERIK does not require special monitoring for laboratory abnormalities.

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

See how TAZVERIK performed in

the clinical trial.

EFFICACY DATA

See the dosing schedule for

patients taking TAZVERIK.

DOSING & ADMINISTRATION

IMPORTANT SAFETY INFORMATION AND INDICATION

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 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.

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.

 

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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.

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