Rx Item-Zolinza 100Mg Cap 120 By Merck

ZOLINZA- vorinostat capsule
Merck Sharp & Dohme Corp.
ZOLINZA: Package Insert and Label Information
By Merck Sharp & Dohme Corp. | Last revised: 17 December 2015
ZOLINZA- vorinostat capsule
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.
3 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.
DESCRIPTION

ZOLINZA contains vorinostat, which is described chemically as N- hydroxy-N'- phenyloctanediamide.
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Vorinostat inhibits the enzymatic activity of histone deacetylases HDAC1, HDAC2 and HDAC3 (Class I) and HDAC6 (Class II) at nanomolar concentrations (IC50 <86 nM). These enzymes catalyze the removal of acetyl groups from the lysine residues of proteins, including histones and transcription factors. In some cancer cells, there is an overexpression of HDACs, or an aberrant recruitment of HDACs to oncogenic transcription factors causing hypoacetylation of core nucleosomal histones. Hypoacetylation of histones is associated with a condensed chromatin structure and repression of gene transcription. Inhibition of HDAC activity allows for the accumulation of acetyl groups on the histone lysine residues resulting in an open chromatin structure and transcriptional activation. In vitro , vorinostat causes the accumulation of acetylated histones and induces cell cycle arrest and/or apoptosis of some transformed cells. The mechanism of the antineoplastic effect of vorinostat has not been fully characterized.

HOW SUPPLIED/STORAGE AND HANDLING

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 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

RX ITEM-Zolinza 100Mg Cap 120 By Merck
NDC 00006-0568-40 UPC/GTIN No.3-00060-56840-4 Mfg.Part No.3883

Zolinza 100Mg Cap 120 By Merck
BRAND: ZOLINZA NDC: 00006-0568-40,6056840 UPC: 3-00060-56840-4,300060568404 Merck & Co.

VORINOSTAT ORAL CAPSULE 1
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