Description

ZOLINZA (Vorinostat)

Generic Name

Vorinostat

Brand Name

ZOLINZA®

Therapeutic Class

Histone Deacetylase (HDAC) Inhibitor / Antineoplastic Agent

Description

ZOLINZA (vorinostat) is an orally administered histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following two prior systemic therapies.

Indication

ZOLINZA is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) whose disease has progressed, persisted, or recurred after two systemic therapies.

Mechanism of Action

Vorinostat inhibits histone deacetylase enzymes (HDACs), resulting in the accumulation of acetylated histones and other proteins. This alters gene expression, promotes cell-cycle arrest, induces differentiation, and triggers apoptosis in malignant cells.

Dosage and Administration

The recommended dose is 400 mg orally once daily with food. Treatment may continue until disease progression or unacceptable toxicity occurs. Dose reductions may be required for patients who experience adverse reactions or have hepatic impairment. Capsules should be swallowed whole and should not be opened or crushed.

Common Adverse Reactions

The most frequently reported adverse reactions include:

• Diarrhea
• Fatigue
• Nausea
• Thrombocytopenia
• Anorexia
• Dysgeusia (taste alteration)
• Vomiting
• Weight loss
• Constipation
• Anemia

Warnings and Precautions

• Monitor for thromboembolic events such as deep vein thrombosis and pulmonary embolism.
• Regular monitoring of blood counts is recommended due to the risk of thrombocytopenia and anemia.
• Gastrointestinal toxicity, including nausea, vomiting, and diarrhea, may lead to dehydration.
• Blood glucose and electrolyte levels should be monitored periodically.
• Embryo-fetal toxicity may occur; effective contraception is recommended during treatment.

Use in Special Populations

The safety and effectiveness of ZOLINZA in pediatric patients have not been established. Dose adjustment is recommended in patients with hepatic impairment. Use during pregnancy should be avoided due to potential fetal harm.

Storage

Store at room temperature and protect from excessive heat and moisture. Keep capsules in their original container and out of reach of children.

Manufacturer

ZOLINZA is marketed by Merck & Co., Inc..