Adult Dosing

Cutaneous T-cell lymphoma (refractory)

• 400 mg PO qd
• Intolerant patients: May reduce to 300 mg PO qd or 300 mg PO qd x 5 days/wk

• Continue treatment as long as there is no evidence of progressive disease or unacceptable toxicity
• Administer with food
• Do not open or crush the capsule

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Use with caution; dose adjustments not defined

• Pulmonary embolism and DVT have been reported with vorinostat. Use cautiously in patients with history of thromboembolic events
• Dose related thrombocytopenia and anemia, requiring dose modification or discontinuation, may occur
• GI disturbances such as diarrhea, nausea, vomiting may occur. Provide respective treatment and give fluid and electrolyte to prevent dehydration
• Reports of hyperglycemia; monitor serum glucose level and modify diet and/or therapy for increased blood glucose
• Severe thrombocytopenia and GI bleeding may occur with concomitant use of vorinostat and other HDAC inhibitors (e.g., valproic acid). Monitor platelet count every 2 wks for first two months of therapy
• Monitor CBC and blood chemistry, including electrolytes; glucose, and serum creatinine every 2 weeks during the first 2 months of therapy and monthly thereafter. Perform ECGs during treatment

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Thrombocytopenia
• Anemia
• History of thromboembolism
• Electrolyte abnormalities
• Diabetes mellitus

Pregnancy Category:D

Breastfeeding: Safety unknown. It is not known whether vorinostat is excreted in human milk, as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

• GI: Diarrhea, nausea, anorexia, weight decrease, vomiting, constipation, dysgeusia, xerostomia, cholecystitis, GI hemorrhage
• CV: Pulmonary embolism, deep vein thrombosis, MI
• CNS: Dizziness, headache, ischemic stroke, syncope, spinal cord injury
• RESP: Cough, URTIs
• METABOLIC: Weight loss, hypokalemia
• ENDO: Hyperglycemia
• GU: Proteinuria, urinary obstruction, elevated creatinine
• ONCO: Squamous cell carcinoma, T-cell lymphoma
• DERM: Alopecia, pruritis, exfoliative dermatitis
• MUSC: Muscle spasms
• HEMA: Thrombocytopenia, anemia
• MISC: Fatigue, chills, peripheral edema, dehydration, severe infections, fever

• Histone deacetylase inhibitor; induces histone acetylation; decreases gene transcription resulting in cell cycle arrest and/or apoptosis of some transformed cells
• Well absorbed following oral administration
• Hepatically metabolized by hydrolysis and glucuronidation followed by beta-oxidation
• Excreted in urine (<1% unchanged)
• Half-life: 2 hrs

US Trade Name(s)

• Zolinza

US Availability

Zolinza

• CAPS: 100 mg

Canadian Trade Name(s)

• Zolinza

Canadian Availability

Zolinza

• CAPS: 100 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Miscellaneous Agents

Drug Name: Zolinza 100 MG Oral Capsule

Ingredient(s): Vorinostat

Imprint: 568;100;mg

Color(s): White

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): gelatin / magnesium stearate / microcrystalline cellulose / sodium croscarmellose / sodium lauryl sulfate / titanium dioxide

Drug Label Author:
Merck & Co., Inc.

DEA Schedule:
Non-Scheduled