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Prescribing Information

ZOLINZA® (vorinostat) Capsules
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Important Product Information

ZOLINZA is indicated for treatment of cutaneous manifestations in patients with CTCL who have progressive, persistent, or recurrent disease on or following 2 systemic therapies.

Selected important cautionary information

Pulmonary embolism and deep vein thrombosis have been reported. Monitor patients for pertinent signs and symptoms, particularly in patients with a history of thromboembolic events.

Treatment with ZOLINZA can cause dose-related thrombocytopenia and anemia. If platelet counts and/or hemoglobin are reduced during treatment, modify the dose or discontinue therapy.

Gastrointestinal (GI) disturbances (eg, nausea, vomiting, and diarrhea) may require antiemetics, antidiarrheals, and fluid and electrolyte replacement to prevent dehydration. Adequately control preexisting GI disturbances before beginning therapy with ZOLINZA.

Hyperglycemia has been observed. Monitor serum glucose, especially in diabetic or potentially diabetic patients. Adjustment of diet, therapy for increased glucose, or both may be necessary to prevent hyperglycemia.

QTc prolongation has been observed. Monitor electrolytes and ECGs at baseline and periodically during treatment. Administer with caution in patients who have or may develop QTc prolongation. Hypokalemia or hypomagnesemia should be corrected before administering ZOLINZA.

The most common adverse events observed in clinical trials with ZOLINZA, regardless of causality, were fatigue (52%), diarrhea (52%), nausea (41%), dysgeusia (28%), thrombocytopenia (26%), anorexia (24%), decreased weight (21%), and muscle spasms (20%).

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

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