Tazverik

— THERAPEUTIC CATEGORIES —
  • Bone and connective tissue cancer
  • Leukemias, lymphomas, and other hematologic cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Tazverik Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tazemetostat 200mg; tabs.

    Pharmacological Class

    Methyltransferase inhibitor.

    How Supplied

    Tabs—240

    Manufacturer

    Epizyme, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Tazemetostat is an inhibitor of the methyltransferase, EZH2, and some EZH2 gain-of-function mutations including Y646X and A687V.

    Tazverik Indications

    Indications

    Metastatic or locally advanced epithelioid sarcoma in patients not eligible for complete resection.

    Tazverik Dosage and Administration

    Adult

    Swallow whole. ≥16yrs: 800mg twice daily; continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions or for drug interactions: see full labeling.

    Children

    <16yrs: not established.

    Tazverik Contraindications

    Not Applicable

    Tazverik Boxed Warnings

    Not Applicable

    Tazverik Warnings/Precautions

    Warnings/Precautions

    Increased risk for secondary malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, B-cell acute lymphoblastic leukemia); monitor long-term. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception (non-hormonal) during and for 6 months (females of reproductive potential) and for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

    Tazverik Pharmacokinetics

    Absorption

    Mean absolute oral bioavailability:~33%. Median time to reach the peak plasma concentration: 1–2 hours.

    Distribution

    Apparent volume of distribution at steady-state: 1230 L. Plasma protein bound: 88%.

    Metabolism

    Hepatic (CYP3A).

    Elimination

    Fecal (79%), renal (15%). Half-life: 3.1 hours.

    Tazverik Interactions

    Interactions

    May be potentiated by strong or moderate CYP3A inhibitors; avoid. If concomitant use with moderate CYP3A inhibitors is unavoidable, reduce dose (see full labeling). May be antagonized by strong or moderate CYP3A inducers; avoid. May antagonize CYP3A substrates, including hormonal contraceptives.

    Tazverik Adverse Reactions

    Adverse Reactions

    Pain, fatigue, nausea, decreased appetite, vomiting, constipation, upper RTI, musculoskeletal pain, abdominal pain; lab abnormalities.

    Tazverik Clinical Trials

    See Literature

    Tazverik Note

    Not Applicable

    Tazverik Patient Counseling

    See Literature

    Tazverik Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tazemetostat 200mg; tabs.

    Pharmacological Class

    Methyltransferase inhibitor.

    How Supplied

    Tabs—240

    Manufacturer

    Epizyme, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Tazemetostat is an inhibitor of the methyltransferase, EZH2, and some EZH2 gain-of-function mutations including Y646X and A687V.

    Tazverik Indications

    Indications

    Relapsed or refractory follicular lymphoma in patients 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, or in patients with no satisfactory alternative treatment options.

    Tazverik Dosage and Administration

    Adult

    Confirm presence of EZH2 mutation of codons Y646, A682, or A692 in tumor specimens. Swallow whole. ≥16yrs: 800mg twice daily; continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions or for drug interactions: see full labeling.

    Children

    <16yrs: not established.

    Tazverik Contraindications

    Not Applicable

    Tazverik Boxed Warnings

    Not Applicable

    Tazverik Warnings/Precautions

    Warnings/Precautions

    Increased risk for secondary malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, B-cell acute lymphoblastic leukemia); monitor long-term. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise to use effective contraception (non-hormonal) during and for 6 months (females of reproductive potential) and for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

    Tazverik Pharmacokinetics

    Absorption

    Mean absolute oral bioavailability:~33%. Median time to reach the peak plasma concentration: 1–2 hours.

    Distribution

    Apparent volume of distribution at steady-state: 1230 L. Plasma protein bound: 88%.

    Metabolism

    Hepatic (CYP3A).

    Elimination

    Fecal (79%), renal (15%). Half-life: 3.1 hours.

    Tazverik Interactions

    Interactions

    May be potentiated by strong or moderate CYP3A inhibitors; avoid. If concomitant use with moderate CYP3A inhibitors is unavoidable, reduce dose (see full labeling). May be antagonized by strong or moderate CYP3A inducers; avoid. May antagonize CYP3A substrates, including hormonal contraceptives.

    Tazverik Adverse Reactions

    Adverse Reactions

    Pain, fatigue, nausea, decreased appetite, vomiting, constipation, upper RTI, musculoskeletal pain, abdominal pain; lab abnormalities.

    Tazverik Clinical Trials

    See Literature

    Tazverik Note

    Not Applicable

    Tazverik Patient Counseling

    See Literature

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