Zolinza
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
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/Storage and Handling].
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
ZOLINZA is contraindicated in patients with severe hepatic impairment [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].
No information is available in patients with renal impairment [see CLINICAL PHARMACOLOGY].
HOW SUPPLIED
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].
REFERENCES
1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. NIH [2002]. 1999 recommendations for the safe handling of cytotoxic drugs. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, NIH Publication No. 92-2621.
4. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs.
5. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
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
Last reviewed on RxList: 11/29/2011
This monograph has been modified to include the generic and brand name in many instances.
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