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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

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

    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
    		    

    Fatigue*

    36

    5

    Pyrexia

    10

    0
    Infections
    		    

    Upper respiratory tract infection†

    30

    0

    Lower respiratory tract infection‡

    17

    0

    Urinary tract infection§

    11

    2
    Gastrointestinal
    		    

    Nausea

    24

    1

    Abdominal pain‖

    20

    3

    Diarrhea

    18

    0

    Vomiting

    12

    1
    Musculoskeletal and connective tissue
    		    

    Musculoskeletal pain

    22

    1
    Skin and subcutaneous tissue
    		    

    Alopecia

    17

    0

    Rash#

    15

    0
    Respiratory and mediastinal system
    		    

    Cough**

    17

    0
    Nervous system
    		    

    Headache††

    13

    0

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

    Clinically relevant adverse reactions occurring in <10% of patients who received TAZVERIK included1:Infection: sepsis (2%), pneumonia (2%), and herpes zoster (2%)

    • *Includes fatigue and asthenia.
    • †Includes laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection.
    • ‡Includes bronchitis, lower respiratory tract infection, tracheobronchitis.
    • §Includes cystitis, urinary tract infection, urinary tract infection staphylococcal.
    • ‖Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper.
    • 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.
    • #Includes erythema, rash, rash erythematous, rash generalized, rash maculopapular, rash pruritic, rash pustular, skin exfoliation.
    • **Includes cough and productive cough.
    • ††Includes headache, migraine, sinus headache.

    R/R=relapsed or refractory.

    Reference: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., August 2024.

    Lab Abnormalities

    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 aminotransferase

    24

    0

    Increased alanine aminotransferase

    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 1 posttreatment value.

    TAZVERIK does not require special monitoring for laboratory abnormalities.1

    R/R=relapsed or refractory; FL=follicular lymphoma.

    Reference: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., August 2024.

    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 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 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 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.

    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.