ZOLINZA¹ 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.

Dosing Information

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].

Dose Modifications

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.

Dosing in Special Populations

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

Dosage Forms And Strengths

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

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].

¹Trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey 08889, USA.
Manufactured for: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA . Manufactured by: Patheon, Inc. Mississauga, Ontario, Canada L5N 7K9. FDA Rev date: 07/21/08

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