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FOR U.S. HEALTHCARE PROFESSIONALS ONLY

GUIDANCE FOR TAZVERIK® DOSE REDUCTIONS AND MODIFICATIONS

GUIDANCE FOR TAZVERIK®
DOSE REDUCTIONS AND
MODIFICATIONS

Recommended dose reductions of TAZVERIK for adverse reactions1

DOSE REDUCTION

DOSAGE

First

600 mg orally twice daily

Second

400 mg orally 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 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

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 strong or 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 disease1
  • Mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment1†

DOSE ADJUSTMENTS ARE NOT RECOMMENDED FOR PATIENTS WITH:
  • Mild to severe renal impairment, including end-stage renal disease1
  • Mild hepatic impairment. TAZVERIK has not been studied in patients with moderate or severe hepatic impairment1†

 

†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.

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

 

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

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 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.