ZOLINZA capsules, 100 mg, are white, opaque hard gelatin capsules with “568” over “100 mg” printed within the radial bar in black ink on the capsule body. They are supplied as follows:

NDC  0006‑0568-40.

Each bottle contains 120 capsules.

Storage and Handling

Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (59-86°F). [See USP Controlled Room Temperature.]

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.{1-5} There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

ZOLINZA (vorinostat) capsules should not be opened or crushed. Direct contact of the powder in ZOLINZA capsules with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed and/or broken capsules [see Nonclinical Toxicology (13.1)].

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889, USA

Manufactured by:Patheon, Inc.Mississauga, Ontario, Canada L5N 7K9

Printed in USA

9762604

U.S. Patent Nos. RE 38,506 E, 6,087,367

Copyright © 2006, 2008, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved

[See FDA-Approved Patient Labeling (17.2)]

Patients should be instructed to drink at least 2 L/day of fluid to prevent dehydration and should promptly report excessive vomiting or diarrhea to their physician. Patients should be instructed about the signs of deep vein thrombosis and should consult their physician should any evidence of deep vein thrombosis develop. Patients receiving ZOLINZA should seek immediate medical attention if unusual bleeding occurs. ZOLINZA capsules should not be opened or crushed.

Patients should be instructed to read the patient insert carefully.

Patient Information ZOLINZA® (zo LINZ ah) (vorinostat) Capsules

Read the patient information that comes with ZOLINZA before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is ZOLINZA?

ZOLINZA is a prescription medicine used to treat a type of cancer called cutaneous T-cell lymphoma (CTCL) in patients when the CTCL gets worse, does not go away, or comes back after treatment with other medicines.

ZOLINZA has not been studied in children under the age of 18.

What should I tell my doctor before taking ZOLINZA?

Tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all of the medicines you take, including p