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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

TAZVERIK® SAFETY WAS ASSESSED ACROSS CLINICALLY DIVERSE R/R FOLLICULAR LYMPHOMA (FL) PATIENTS (N=99)1

R/R=relapsed or refractory

DISCONTINUATIONS

of patients permanently discontinued treatment due to an adverse reaction. The adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.1

8% of patients permanently discontinued treatment due to an adverse reaction. The adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.1

REDUCTIONS

of patients receiving TAZVERIK® required dose reductions due to an adverse reaction.1

9% of patients receiving TAZVERIK® required dose reductions due to an adverse reaction.1

INTERRUPTIONS

of patients receiving TAZVERIK required dose interruptions due to an adverse reaction. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.1

28% of patients receiving TAZVERIK required dose interruptions due to an adverse reaction. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.1

Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% of patients taking TAZVERIK included general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia.1

The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).1

Adverse reactions (≥10%) in patients with relapsed or refractory (R/R) FL who received TAZVERIK (N=99)1

ADVERSE REACTION

ALL GRADES (%)

GRADE 3 OR 4 (%)
General
    
Fatiguea 36 5
Pyrexia 10 0
Infections
    
Upper respiratory tract infectionb 30 0
Lower respiratory tract infectionc 17 0
Urinary tract infectiond 11 2
Gastrointestinal
    
Nausea 24 1
Abdominal paine 20 3
Diarrhea 18 0
Vomiting 12 1
Musculoskeletal and connective tissue
    
Musculoskeletal painf 22 1
Skin and subcutaneous tissue
    
Alopecia 17 0
Rashg 15 0
Respiratory and mediastinal system
    
Coughh 17 0
Nervous system
    
Headachei 13 0

≤5% of patients experienced Grade 3 or 4 adverse reactions.1

  1. Includes fatigue and asthenia.
  2. Includes laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection.
  3. Includes bronchitis, lower respiratory tract infection, tracheobronchitis.
  4. Includes cystitis, urinary tract infection, urinary tract infection staphylococcal.
  5. Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper.
  6. Includes back pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain.
  7. Includes erythema, rash, rash erythematous, rash generalized, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation.
  8. Includes cough and productive cough.
  9. Includes headache, migraine, sinus headache.

Clinically relevant adverse reactions occurring in <10% of patients who received TAZVERIK included:

  • Infection: sepsis (2%), pneumonia (2%), and herpes zoster (2%)

Select laboratory abnormalities (≥10%) worsening from baseline in patients with R/R FL who received TAZVERIK1

LABORATORY ABNORMALITY

TAZVERIK*

ALL GRADES (%)

GRADE 3 OR 4 (%)
Hematology
    
Decreased lymphocytes 57 18
Decreased hemoglobin 50 8
Decreased platelets 50 7
Decreased white blood cells 41 9
Decreased neutrophils 20 7
Chemistry
    
Increased glucose 53 10
Increased aspartate aminostransferase 24 0
Increased alanine aminostransferase 21 2.3
Increased alkaline phosphatase 18 1.0
Increased creatinine 17 0

*The denominator used to calculate the rate varied from 88 to 96 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.

FL=follicular lymphoma.

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

See how TAZVERIK performed

in the clinical study.

CLINICAL TRIAL RESULTS

See the recommended dosing schedule

for patients taking TAZVERIK.

RECOMMENDED DOSE

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