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SAFETY EVALUATED IN PATIENTS INCLUDED IN THE STUDY WITH METASTATIC OR LOCALLY ADVANCED EPITHELIOID SARCOMA (N=62)1

Serious adverse reactions occurred in 37% of patients who received TAZVERIK™ (tazemetostat). 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

1 of 62

One patient required permanent discontinuation of treatment due to an adverse reaction of altered mood1

Adverse reactions (≥10%) in patients who received TAZVERIK (N=62)1

Adverse Reaction
TAZVERIK (N=62)
All Grades (%)
Grade 3 or 4 (%)
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 pain
  2. Includes fatigue and asthenia
  3. Includes abdominal pain, gastrointestinal pain, abdominal pain lower
  4. Includes dyspnea and dyspnea exertional
  5. Includes wound hemorrhage, rectal hemorrhage, pulmonary hemorrhage, hemorrhage intracranial, cerebral hemorrhage, hemoptysis
Reference: 1. TAZVERIK™ (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., June 2020.

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Dosing & Administration
INDICATION AND IMPORTANT SAFETY INFORMATION

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).

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 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.

Before prescribing TAZVERIK, please read the full Prescribing Information.