For U.S. Healthcare Professionals Only

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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

GUIDANCE FOR TAZVERIK® DOSE REDUCTIONS AND MODIFICATIONS

Recommended dose reductions of TAZVERIK® for adverse reactions1

DOSE REDUCTION

DOSAGE
First 600 mg twice daily
Second 400 mg twice daily*

 

*Permanently discontinue TAZVERIK in patients who are unable to tolerate 400 mg orally twice daily.1

Recommended dosage modifications of TAZVERIK for adverse reactions1

ADVERSE REACTION

SEVERITY

DOSAGE MODIFICATION
Neutropenia Neutrophil count less than 1 x 109/L
  • Withhold until neutrophil count is greater than or equal to 1 × 109/L or baseline.
  • For first occurrence, resume at same dose.
  • For second and third occurrence, resume at reduced dose.
  • Permanently discontinue after fourth occurrence.
Thrombocytopenia Platelet count less than 50 x 109/L
  • Withhold until platelet count is greater than or equal to 75 × 109/L or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Anemia Hemoglobin less than 8g/dL
  • Withhold until improvement to at least Grade 1 or baseline, then resume at same or reduced dose.
Other adverse reactions Grade 3
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Grade 4
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first occurrence, resume at reduced dose.
  • Permanently discontinue after second occurrence.

ADVERSE REACTION & SEVERITY

DOSAGE MODIFICATION
Neutropenia Neutrophil count less than 1 x 109/L
  • Withhold until neutrophil count is greater than or equal to 1 × 109/L or baseline.
  • For first occurrence, resume at same dose.
  • For second and third occurrence, resume at reduced dose.
  • Permanently discontinue after fourth occurrence.
Thrombocytopenia Platelet count less than 50 x 109/L
  • Withhold until platelet count is greater than or equal to 75 × 109/L or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Anemia Hemoglobin less than 8 g/dL
  • Withhold until improvement to at least Grade 1 or baseline, then resume at same or reduced dose.
Other adverse reactions Grade 3
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first and second occurrence, resume at reduced dose.
  • Permanently discontinue after third occurrence.
Other adverse reactions Grade 4
  • Withhold until improvement to at least Grade 1 or baseline.
  • For first occurrence, resume at reduced dose.
  • Permanently discontinue after second occurrence.

Review the Select Lab Abnormalities table when considering dose modifications for adverse reactions.

Recommended dose reductions of TAZVERIK for moderate CYP3A inhibitors, where coadministration cannot be avoided1

CURRENT DOSAGE

ADJUSTED DOSAGE
800 mg orally twice daily 400 mg orally twice daily
600 mg orally twice daily 400 mg for first dose and
200 mg for second dose
400 mg orally twice daily 200 mg orally twice daily

DOSE ADJUSTMENTS ARE NOT RECOMMENDED FOR PATIENTS WITH:
  • mild to severe renal impairment, including end-stage renal disease.1
  • mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment.1†

DOSE ADJUSTMENTS ARE NOT RECOMMENDED FOR PATIENTS WITH:
  • mild to severe renal impairment, including end-stage renal disease.1
  • mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment.1†

 

†Mild=total bilirubin > 1 to 1.5 times ULN or AST > ULN; moderate=total bilirubin > 1.5 to 3 times ULN; severe=total bilirubin > 3 times ULN.1

CYP3A=Cytochrome P450 (CYP)3A; ULN=upper limit of normal; AST=aspartate aminotransferase.

 

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

 

See the recommended dosing
schedule for patients taking
TAZVERIK.

RECOMMENDED DOSE

Learn more about how
TAZVERIK works in FL.

MECHANISM OF ACTION

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