Tazverik

Last updated on RxList: 10/13/2020
Tazverik Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tazverik?

Tazverik (tazemetostat) is a methyltransferase inhibitor used to treat adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

What Are Side Effects of Tazverik?

Side effects of Tazverik include:

  • pain,
  • fatigue,
  • nausea,
  • decreased appetite,
  • vomiting,
  • constipation,
  • diarrhea,
  • abdominal pain,
  • cough,
  • shortness of breath,
  • bleeding,
  • headache,
  • anemia, and
  • weight loss

Dosage for Tazverik

The recommended dosage of Tazverik is 800 mg taken orally twice daily with or without food.

Tazverik In Children

The safety and effectiveness of Tazverik have been established in pediatric patients aged 16 years and older (adolescents) with metastatic or locally advanced epithelioid sarcoma. The safety and effectiveness of Tazverik in pediatric patients aged less than 16 years have not been established.

What Drugs, Substances, or Supplements Interact with Tazverik?

Tazverik may interact with other medicines such as:

  • strong and moderate CYP3A inhibitors,
  • strong and moderate CYP3A inducers, and
  • CYP3A substrates, including hormonal contraceptives

Tell your doctor all medications and supplements you use.

Tazverik During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tazverik; it may harm a fetus. Females of reproductive potential are advised to use effective non-hormonal contraception during treatment with Tazverik and for 6 months after the final dose. Tazverik can render some hormonal contraceptives ineffective. Males with female partners of reproductive potential are advised to use effective contraception during treatment with Tazverik and for at least 3 months after the final dose. It is unknown if Tazverik passes into breast milk. Because of the potential risk for serious adverse reactions from Tazverik in the breastfed child, women are advised not to breastfeed during treatment with Tazverik and for one week after the final dose.

Consult your doctor before breastfeeding.

Additional Information

Our Tazverik (tazemetostat) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow
Tazverik Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual tiredness;
  • bone pain; or
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • constipation;
  • pain; or
  • tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tazverik (Tazemetostat Tablets)

Tazverik Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in labeling:

  • Secondary Malignancies [see WARNINGS AND PRECAUTIONS].

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Epithelioid Sarcoma

The safety of TAZVERIK was evaluated in a cohort (Cohort 5) of Study EZH-202 that enrolled patients with epithelioid sarcoma [see Clinical Studies]. Patients received TAZVERIK 800 mg orally twice daily (n=62). Among patients who received TAZVERIK, 44% were exposed for 6 months or longer and 24% were exposed for greater than one year.

Serious adverse reactions occurred in 37% of patients who received TAZVERIK. Serious adverse reactions in ≥3% of patients who received TAZVERIK were hemorrhage, pleural effusion, skin infection, dyspnea, pain, and respiratory distress.

One patient (2%) permanently discontinued TAZVERIK due to an adverse reaction of altered mood.

Dosage interruptions due to an adverse reaction occurred in 34% of patients who received TAZVERIK. The most frequent adverse reactions requiring dosage interruptions in ≥3% were hemorrhage, increased alanine aminotransferase (ALT), and increased aspartate aminotransferase (AST).

Dose reduction due to an adverse reaction occurred in one (2%) patient who received TAZVERIK; the dose was reduced in this patient for decreased appetite.

The most common adverse reactions (≥20%) were pain, fatigue, nausea, decreased appetite, vomiting, and constipation.

Table 4 presents adverse reactions in patients with epithelioid sarcoma in Cohort 5 of Study EZH-202.

Table 4: Adverse Reactions (≥10%) in Patients with Epithelioid Sarcoma Who Received TAZVERIK in Cohort 5 of Study EZH-202

Adverse ReactionTAZVERIK
N=62
All Grades (%)Grade 3 or 4 (%)
General
Paina527
Fatigueb471.6
Gastrointestinal
Nausea360
Vomiting240
Constipation210
Diarrhea160
Abdominal painc131.6
Metabolism and nutrition
Decreased appetite264.8
Respiratory, thoracic and mediastinal
Cough180
Dyspnead164.8
Vascular
Hemorrhagee184.8
Nervous system
Headache180
Investigations
Weight decreased167
a Includes tumor pain, pain in extremity, non-cardiac chest pain, flank pain, back pain, arthralgia, bone pain, cancer pain, musculoskeletal pain, myalgia, neck pain
b Includes fatigue and asthenia
c Includes abdominal pain, gastrointestinal pain, abdominal pain lower
d Includes dyspnea and dyspnea exertional
e Includes wound hemorrhage, rectal hemorrhage, pulmonary hemorrhage, hemorrhage intracranial, cerebral hemorrhage, hemoptysis

Table 5 summarizes select laboratory abnormalities in patients with epithelioid sarcoma in Cohort 5 of Study EZH-202.

Table 5: Select Laboratory Abnormalities (≥ 10%) Worsening from Baseline in Patients with Epithelioid Sarcoma Who Received TAZVERIK in Cohort 5 of Study EZH-202

Laboratory AbnormalityTAZVERIK*
All Grades (%)Grade 3 or 4 (%)
Hematology
Decreased hemoglobin4915
Decreased lymphocytes3613
Decreased white blood cell count190
Chemistry
Increased triglycerides363.3
Increased glucose331.6
Decreased sodium301.7
Decreased phosphate281.7
Decreased albumin230
Increased alkaline phosphatase231.7
Decreased potassium201.7
Increased aspartate aminotransferase183.5
Decreased calcium160
Decreased glucose160
Increased partial thromboplastin time155
Increased alanine aminotransferase143.4
Increased creatinine120
Increased potassium120
*The denominator used to calculate the rate varied from 39 to 61 based on the number of patients with a baseline value and at least one post-treatment value.

Relapsed Or Refractory Follicular Lymphoma

The safety of TAZVERIK was evaluated in two cohorts (Cohorts 4 and 5) of Study E7438-G000-101 that enrolled patients with relapsed or refractory follicular lymphoma [see Clinical Studies]. Patients received TAZVERIK 800 mg orally twice daily (n=99). Among patients who received TAZVERIK, 68% were exposed for 6 months or longer, 39% were exposed for 12 months or longer, and 21% were exposed for 18 months or longer.

The median age was 62 years (range 36 to 87 years), 54% were male, and 95% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The median number of prior therapies was 3 (range 1 to 11). Patients were required have a creatinine clearance ≥40 mL/min per the Cockcroft and Gault formula.

Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions in ≥2% of patients who received TAZVERIK were general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia.

Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received TAZVERIK. Adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.

Dosage interruptions due to an adverse reaction occurred in 28% of patients who received TAZVERIK. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.

Dose reduction due to an adverse reaction occurred in 9% of patients who received TAZVERIK.

The most common adverse reactions (≥20%) were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.

Table 6 presents adverse reactions in patients with relapsed or refractory follicular lymphoma in Cohorts 4 and 5 of Study E7438-G000-101.

Table 6: Adverse Reactions (≥10%) in Patients with Relapsed or Refractory Follicular Lymphoma Who Received TAZVERIK in Cohorts 4 and 5 of Study E7438-G000-101

Adverse ReactionTAZVERIK
N=99
All Grades (%)Grade 3 or 4 (%)
General
Fatiguea365
Pyrexia100
Infections
Upper respiratory tract infectionb300
Lower respiratory tract infectionc170
Urinary tract infectiond112
Gastrointestinal
Nausea241
Abdominal paine203
Diarrhea180
Vomiting121
Musculoskeletal and connective tissue
Musculoskeletal painf221
Skin and subcutaneous tissue
Alopecia170
Rashg150
Respiratory and mediastinal system
Coughh170
Nervous system
Headachei130
a Includes fatigue and asthenia
b Includes laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper repiratory tract infection, viral upper respiratory tract infection
c Includes bronchitis, lower respiratory tract infection, tracheobronchitis
d Includes cystitis, urinary tract infection, urinary tract infection staphylococcal
e Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper
f Includes back pain, limb discomfort, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain
g Includes erythema, rash, rash erythematous, rash generalized, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation
h Includes cough and productive cough
i Includes headache, migraine, sinus headache

Clinically relevant adverse reactions occurring in <10% of patients who received TAZVERIK included:

  • Infection: sepsis (2%), pneumonia (2%), and herpes zoster (2%)

Table 7 summarizes select laboratory abnormalities in patients with follicular lymphoma in Cohorts 4 and 5 of Study E7438-G000-101.

Table 7: Select Laboratory Abnormalities (≥10%) Worsening from Baseline in Patients with Relapsed or Refractory Follicular Lymphoma Who Received TAZVERIK in Cohorts 4 and 5 of Study E7438-G000-101

Laboratory AbnormalityTAZVERIK*
All Grades (%)Grade 3 or 4 (%)
Hematology
Decreased lymphocytes5718
Decreased hemoglobin508
Decreased platelets507
Decreased white blood cells419
Decreased neutrophils207
Chemistry
Increased glucose5310
Increased aspartate aminotransferase240
Increased alanine aminotransferase212.3
Increased alkaline phosphatase181.0
Increased creatinine170
*The denominator used to calculate the rate varied from 88 to 96 based on the number of patients with a baseline value and at least one post-treatment value.

Read the entire FDA prescribing information for Tazverik (Tazemetostat Tablets)

© Tazverik Patient Information is supplied by Cerner Multum, Inc. and Tazverik Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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