DISCONTINUATIONS

of patients permanently discontinued treatment due to an adverse reaction. The adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.1
8% of patients permanently discontinued treatment due to an adverse reaction. The adverse reaction resulting in permanent discontinuation in ≥2% of patients was second primary malignancy.1
REDUCTIONS

of patients receiving TAZVERIK® required dose reductions due to an adverse reaction.1
9% of patients receiving TAZVERIK® required dose reductions due to an adverse reaction.1
INTERRUPTIONS

of patients receiving TAZVERIK required dose interruptions due to an adverse reaction. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.1
28% of patients receiving TAZVERIK required dose interruptions due to an adverse reaction. Adverse reactions requiring dosage interruptions in ≥3% of patients were thrombocytopenia and fatigue.1
Serious adverse reactions occurred in 30% of patients who received TAZVERIK. Serious adverse reactions occurring in ≥2% of patients taking TAZVERIK included general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia.1
The most common (≥20%) adverse reactions were fatigue (36%), upper respiratory tract infection (30%), musculoskeletal pain (22%), nausea (24%), and abdominal pain (20%).1
Adverse reactions (≥10%) in patients with relapsed or refractory (R/R) FL who received TAZVERIK (N=99)1
ADVERSE REACTION |
ALL GRADES (%) |
GRADE 3 OR 4 (%) |
---|---|---|
General |
||
Fatiguea | 36 | 5 |
Pyrexia | 10 | 0 |
Infections |
||
Upper respiratory tract infectionb | 30 | 0 |
Lower respiratory tract infectionc | 17 | 0 |
Urinary tract infectiond | 11 | 2 |
Gastrointestinal |
||
Nausea | 24 | 1 |
Abdominal paine | 20 | 3 |
Diarrhea | 18 | 0 |
Vomiting | 12 | 1 |
Musculoskeletal and connective tissue |
||
Musculoskeletal painf | 22 | 1 |
Skin and subcutaneous tissue |
||
Alopecia | 17 | 0 |
Rashg | 15 | 0 |
Respiratory and mediastinal system |
||
Coughh | 17 | 0 |
Nervous system |
||
Headachei | 13 | 0 |
≤5% of patients experienced Grade 3 or 4 adverse reactions.1
- Includes fatigue and asthenia.
- Includes laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection.
- Includes bronchitis, lower respiratory tract infection, tracheobronchitis.
- Includes cystitis, urinary tract infection, urinary tract infection staphylococcal.
- Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper.
- 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.
- Includes erythema, rash, rash erythematous, rash generalized, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation.
- Includes cough and productive cough.
- 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%)
Select laboratory abnormalities (≥10%) worsening from baseline in patients with R/R FL who received TAZVERIK1
LABORATORY ABNORMALITY |
TAZVERIK* |
||
---|---|---|---|
ALL GRADES (%) |
GRADE 3 OR 4 (%) |
||
Hematology |
|||
Decreased lymphocytes | 57 | 18 | |
Decreased hemoglobin | 50 | 8 | |
Decreased platelets | 50 | 7 | |
Decreased white blood cells | 41 | 9 | |
Decreased neutrophils | 20 | 7 | |
Chemistry |
|||
Increased glucose | 53 | 10 | |
Increased aspartate aminostransferase | 24 | 0 | |
Increased alanine aminostransferase | 21 | 2.3 | |
Increased alkaline phosphatase | 18 | 1.0 | |
Increased creatinine | 17 | 0 |
*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.
TAZVERIK does not require special monitoring for laboratory abnormalities.
FL=follicular lymphoma.
Reference: 1. TAZVERIK (tazemetostat) Prescribing Information. Cambridge, MA: Epizyme, Inc., July 2020.