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. This
indication is approved under accelerated approval based on the 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).
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg film-coated, red, round, biconvex shape and debossed with “EZM 200” on one side and plain
on the other.
WARNINGS AND PRECAUTIONS
Secondary Malignancies: TAZVERIK increases the risk of developing
secondary malignancies, including T-cell lymphoblastic lymphoma,
myelodysplastic syndrome, and acute myeloid leukemia.
Secondary Malignancies;
The risk of developing secondary malignancies is increased following treatment with TAZVERIK. Across
clinical trials of 668 adults who received TAZVERIK 800 mg twice daily, myelodysplastic syndrome (MDS) or
acute myeloid leukemia (AML) occurred in 0.6% of patients. One pediatric patient developed T-cell
lymphoblastic lymphoma (T-LBL).
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
The most common (≥20%) adverse reactions are pain, fatigue, nausea,
decreased appetite, vomiting, and constipation.
DRUG INTERACTIONS
- Strong and Moderate Cytochrome P450 (CYP)3A Inhibitors: Avoid coadministration of strong and moderate CYP3A inhibitors with TAZVERIK. Reduce the dose of TAZVERIK if coadministration of moderate CYP3A inhibitors cannot be avoided.
- Strong and Moderate CYP3A Inducers: Avoid coadministration with TAZVERIK
References;
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