ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following 2 systemic therapies.

Selected Important Safety 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.

Based on reports of dehydration as a serious drug-related adverse event in clinical trials, instruct patients to drink at least 2 L/day of fluids for adequate hydration.

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.

Monitor electrolytes at baseline and periodically during treatment. Hypokalemia or hypomagnesemia should be corrected before administering ZOLINZA.

Severe thrombocytopenia and GI bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (eg, valproic acid). Monitor platelet count every 2 weeks for the first 2 months.

Carefully monitor patients concurrently administered ZOLINZA and coumarin derivatives for prolongation of prothrombin time and international normalized ratio.

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%).

The most common serious adverse events, regardless of causality, were pulmonary embolism (4.7%), squamous cell carcinoma (3.5%), and anemia (2.3%).

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.

ZOLINZA was not evaluated in patients with hepatic impairment. Because ZOLINZA is predominantly eliminated through metabolism, treat patients with hepatic impairment with caution.

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