Brand Name
Zolinza
Generic Name
Vorinostat
View Brand Information FDA approval date: October 06, 2006
Classification: Histone Deacetylase Inhibitor
Form: Capsule
What is Zolinza (Vorinostat)?
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. ZOLINZA is a histone deacetylase inhibitor 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.
Approved To Treat
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Brand Information
ZOLINZA (vorinostat)
1INDICATIONS AND USAGE
ZOLINZA
2DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg white, opaque, hard gelatin capsules with "568" over "100 mg" printed within radial bar in black ink on the capsule body.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions have been associated with ZOLINZA in clinical trials and are discussed in greater detail in other sections of the label:
- Thromboembolism
- Myelosuppression
- Gastrointestinal Toxicity
- Hyperglycemia
- Clinical Chemistry Abnormalities
- Severe thrombocytopenia when combined with other Histone Deacetylase (HDAC) Inhibitors
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ZOLINZA was evaluated in 107 CTCL patients in two single arm clinical studies in which 86 patients received 400 mg once daily.
The data described below reflect exposure to ZOLINZA 400 mg once daily in the 86 patients for a median number of 97.5 days on therapy (range 2 to 480+ days). Seventeen (19.8%) patients were exposed beyond 24 weeks and 8 (9.3%) patients were exposed beyond 1 year. The population of CTCL patients studied was 37 to 83 years of age, 47.7% female, 52.3% male, and 81.4% white, 16.3% black, and 1.2% Asian or multi-racial.
5OVERDOSAGE
No specific information is available on the treatment of overdosage of ZOLINZA.
In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required. It is not known if vorinostat is dialyzable.
6DESCRIPTION
ZOLINZA contains vorinostat, which is described chemically as
The empirical formula is C
Vorinostat is a white to light orange powder. It is very slightly soluble in water, slightly soluble in ethanol, isopropanol and acetone, freely soluble in dimethyl sulfoxide and insoluble in methylene chloride. It has no chiral centers and is non-hygroscopic. The differential scanning calorimetry ranged from 161.7 (endotherm) to 163.9°C. The pH of saturated water solutions of vorinostat drug substance was 6.6. The pKa of vorinostat was determined to be 9.2.
Each 100 mg ZOLINZA capsule for oral administration contains 100 mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The capsule shell excipients are titanium dioxide, gelatin and sodium lauryl sulfate.
7REFERENCES
1. "OSHA Hazardous Drugs."
8HOW 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.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients should be instructed to drink at least 2 L/day of fluid to prevent dehydration and should promptly report excessive vomiting or diarrhea to their physician. Patients should be instructed about the signs of deep vein thrombosis and should consult their physician should any evidence of deep vein thrombosis develop. Patients receiving ZOLINZA should seek immediate medical attention if unusual bleeding occurs. ZOLINZA capsules should not be opened or crushed.
10PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
NDC 0006-0568-40
Zolinza
100 mg
Direct contact of the powder in ZOLINZA
Rx only
120 Capsules
