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Zolinza® [vorinostat] capsules Reactivate Expression
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Safety Profile

Adverse Events Occurring in ≥20% of CTCL Patients, Regardless of Causality

ZOLINZA 400 mg Once Daily (N=86)
Adverse Event Grade 1 Grade 2 Grade 3 Grade 4
  N % N % N % N %
Diarrhea 34 39.5 11 12.8 0 0.0 0 0.0
Fatigue 24 27.9 18 20.9 3 3.5 0 0.0
Nausea 24 27.9 8   9.3 3 3.5 0 0.0
Dysgeusia 21 24.4 3   3.5 0 0.0 0 0.0
Thrombocytopenia 14 16.3 3   3.5 4 4.7 1 1.2
Anorexia 13 15.1 6   7.0 2 2.3 0 0.0
Decreased weight 12 14.0 5   5.8 1 1.2 0 0.0
Muscle spasms 11 12.8 4   4.7 2 2.3 0 0.0

The Most Common Serious Adverse Events Occurring in CTCL Patients, Regardless of Causality

ZOLINZA 400 mg Once Daily (N=86)
Adverse Event N %
Pulmonary embolism 4 4.7
Squamous cell carcinoma 3 3.5
Anemia 2 2.3

Other Serious Adverse Events

  • There were single events of cholecystitis, death (of unknown cause), deep vein thrombosis, enterococcal infection, exfoliative dermatitis, GI hemorrhage, infection, lobar pneumonia, myocardial infarction, ischemic stroke, pelviureteric obstruction, sepsis, spinal cord injury, streptococcal bacteremia, syncope, T-cell lymphoma, thrombocytopenia, and ureteric obstruction.

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ZOLINZA: Patients Requiring Discontinuation

9.3% (8/86) of patients discontinued ZOLINZA due to adverse events. These adverse events, regardless of causality, included:

  • Anemia
  • Angioneurotic edema
  • Asthenia
  • Chest pain
  • Exfoliative dermatitis
  • Death
  • Deep vein thrombosis
  • Ischemic stroke
  • Lethargy
  • Pulmonary embolism
  • Spinal cord injury

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ZOLINZA: Patients Requiring Dose Modification

10.5% (9/86) of patients required a dose modification of ZOLINZA due to adverse events. These adverse events, regardless of causality, included:

  • Increased serum creatinine
  • Decreased appetite
  • Hypokalemia
  • Leukopenia
  • Nausea
  • Neutropenia
  • Thrombocytopenia
  • Vomiting

Median time to dose modification was 42 days (range: 17–263 days).

Selected Important Safety Information

  • ZOLINZA can cause fetal harm when administered to a pregnant woman.
  • It is not known whether ZOLINZA is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug.

Before prescribing ZOLINZA, please read the physician Prescribing Information. The Patient Product Information is also available.

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