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Safety was evaluated in patients
with relapsed or refractory Follicular Lymphoma (N=99)1

30% of patients in the TAZVERIK® (tazemetostat) clinical trial experienced serious adverse reactions.
Serious adverse reactions occurring in ≥2% of patients taking TAZVERIK included:

  • general physical health deterioration
  • abdominal pain
  • pneumonia
  • sepsis
  • anemia1

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 Reaction
TAZVERIK (N=99)
All Grades (%)
Grade 3 or 4 (%)
General
 
 
Fatiguea
All Grades (%):
36
Grade 3 or 4 (%):
5
Pyrexia
All Grades (%):
10
Grade 3 or 4 (%):
0
Infections
 
 
Upper respiratory tract infectionb
All grades (%):
30
Grade 3 or 4 (%):
0
Lower respiratory tract infectionc
All grades (%):
17
Grade 3 or 4 (%):
0
Urinary tract infectiond
All grades (%):
11
Grade 3 or 4 (%):
2
Gastrointestinal
 
 
Nausea
All grades (%):
24
Grade 3 or 4 (%):
1
Abdominal paine
All grades (%):
20
Grade 3 or 4 (%):
3
Diarrhea
All grades (%):
18
Grade 3 or 4 (%):
0
Vomiting
All grades (%):
12
Grade 3 or 4 (%):
1
Musculoskeletal and connective tissue
 
 
Musculoskeletal painf
All grades (%):
22
Grade 3 or 4 (%):
1
Skin and subcutaneous tissue
 
 
Alopecia
All grades (%):
17
Grade 3 or 4 (%):
0
Rashg
All grades (%):
15
Grade 3 or 4 (%):
0
Respiratory and mediastinal system
 
 
Coughh
All grades (%):
17
Grade 3 or 4 (%):
0
Nervous system
 
 
Headachei
All grades (%):
13
Grade 3 or 4 (%):
0
Fatigue was the only grade 3 or 4 adverse reactions reported in ≥5% of patients.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
Reference: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020.

See how TAZVERIK performed
in the clinical study.

efficacy

See the dosing schedule
for patients taking TAZVERIK.

Dosing & Administration
INDICATIONS AND IMPORTANT SAFETY INFORMATION

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).

IMPORTANT SAFETY INFORMATION

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.

Before prescribing TAZVERIK, please read the full Prescribing Information.