Tazverik
(Tazemetostat)Dosage & Administration
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Tazverik Prescribing Information
Dosage and Administration, Modifications for Drug Interactions (Strong or Moderate CYP3A Inhibitors Avoid coadministration of TAZVERIK with strong or moderate CYP3A inhibitors. If coadministration with a strong or moderate CYP3A inhibitor cannot be avoided, reduce the TAZVERIK dose as shown in Table 3below. After discontinuation of the strong or moderate CYP3A inhibitor for 3 elimination half-lives, resume the TAZVERIK dose that was taken prior to initiating the inhibitor [see Drug Interactions , Clinical Pharmacology ] .
| 08/2024 | ||||||||
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. | 11/2023 |
TAZVERIK is a methyltransferase inhibitor 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. ()
1.1 Epithelioid SarcomaTAZVERIK 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
[see Clinical Studies ].Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - 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. ()
1.2 Relapsed or Refractory Follicular Lymphoma- TAZVERIK is indicated for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) 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.
- TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response
[see Clinical Studies ].Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. ()
1.2 Relapsed or Refractory Follicular Lymphoma- TAZVERIK is indicated for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) 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.
- TAZVERIK is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response
[see Clinical Studies ].Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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).
- Recommended dosage is 800 mg taken orally twice daily with or without food. ()
2.2 Recommended DosageThe recommended dosage of TAZVERIK is 800 mg orally twice daily with or without food until disease progression or unacceptable toxicity.
Swallow tablets whole. Do not cut, crush, or chew tablets.
Do not take an additional dose if a dose is missed or vomiting occurs after TAZVERIK, but continue with the next scheduled dose.
Tablets: 200 mg film-coated, red, round, biconvex shape and debossed with "EZM 200" on one side and plain on the other.
- Lactation: Advise not to breastfeed. ()
8.2 LactationRisk SummaryThere are no animal or human data on the presence of tazemetostat in human milk or on its effects on the breastfed child or milk production. 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.
None.