Source: FDA, National Drug Code (US) Revision Year: 2020
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 [see Clinical Studies (14.1)]. Continued approval for this indication 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 [see Clinical Studies (14.2)]. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Select patients with R/R FL for treatment with TAZVERIK based on the presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of EZH2 mutation in relapsed or refractory follicular lymphoma is available at: http://www.fda.gov/CompanionDiagnostics.
The 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.
Table 1 summarizes the recommended dose reductions, and Table 2 summarizes the recommended dosage modifications of TAZVERIK for adverse reactions.
Table 1. Recommended Dose Reductions of TAZVERIK for Adverse Reactions:
| 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.
Table 2. Recommended Dosage Modifications of TAZVERIK for Adverse Reactions:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Neutropenia [see Adverse Reactions (6.1)] | Neutrophil count less than 1 × 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 [see Adverse Reactions (6.1)] | Platelet count less than 50 × 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 [see Adverse Reactions (6.1)] | 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 [see Adverse Reactions (6.1)] | 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. |
Avoid coadministration of TAZVERIK with strong or moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce the TAZVERIK dose as shown in Table 3 below. After discontinuation of the moderate CYP3A inhibitor for 3 elimination half-lives, resume the TAZVERIK dose that was taken prior to initiating the inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Table 3. Recommended Dose Reductions of TAZVERIK for Moderate CYP3A Inhibitors:
| 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 |
Do not store above 30°C (86°F).
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