These highlights do not include all the information needed to use ZOLINZA safely and effectively. See full prescribing information for ZOLINZA. ZOLINZA® (vorinostat) CapsulesInitial U.S. Approval: 2006
ZOLINZA is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

The recommended dose is 400 mg orally once daily with food.

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

ZOLINZA capsules should not be opened or crushed [see How Supplied/Storage and Handling (16)].

If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary.

No information is available in patients with renal or hepatic impairment  [see Pharmacokinetics (12.3)].

100 mg white, opaque, hard gelatin capsules with “568” over “100 mg” printed within radial bar in black ink on the capsule body.

None

As pulmonary embolism and deep vein thrombosis have been reported as adverse reactions, physicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of thromboembolic events [see Adverse Reactions (6)].

Treatment with ZOLINZA can cause dose-related thrombocytopenia and anemia. If platelet counts and/or hemoglobin are reduced during treatment with ZOLINZA, the dose should be modified or therapy discontinued. [See Dosage and Administration (2.2), Warnings and Precautions (5.6) and Adverse Reactions (6).]

Gastrointestinal disturbances, including nausea, vomiting and diarrhea, have been reported [see Adverse Reactions (6)] and may require the use of antiemetic and antidiarrheal medications. Fluid and electrolytes should be replaced to prevent dehydration [see Adverse Reactions (6.1)]. Pre-existing nausea, vomiting, and diarrhea should be adequately controlled before beginning therapy with ZOLINZA.

Hyperglycemia has been observed in patients receiving ZOLINZA [see Adverse Reactions (6.1)]. Serum glucose should be monitored, especially in diabetic or potentially diabetic patients. Adjustment of diet and/or therapy for increased glucose may be necessary.

Careful monitoring of blood cell counts and chemistry tests, including electrolytes, glucose and serum creatinine, should be performed every 2 weeks during the first 2 months of therapy and monthly thereafter. Electrolyte monitoring should include potassium, magnesium and calcium. Hypokalemia or hypomagnesemia should be corrected prior to administration of ZOLINZA, and consideration should be given to monitoring potassium and magnesium in symptomatic patients (e.g., patients with nausea, vomiting, diarrhea, fluid imbalance or cardiac symptoms).

Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Monitor platelet count every 2 weeks during the first 2 months. [See Drug Interactions (7.2)].

Pregnancy Category D

ZOLINZA can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of ZOLINZA in pregnant women. Results of animal studies indicate that vorinostat crosses t