Zolinza label

Zolinza

Zolinza Recall

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Uses

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.

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History

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Other Information

ZOLINZA contains vorinostat, which is described chemically as N-hydroxy-N’-phenyloctanediamide.

The empirical formula is C14H20N2O3. The molecular weight is 264.32 and the structural formula is:

Image of Vorinostat Chemical Structure

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.

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Zolinza Manufacturers

  • Merck Sharp & Dohme Corp.
    Zolinza | Merck Sharp & Dohme Corp.
    No Recall

    Zolinza | Merck Sharp & Dohme Corp.

    Zolinza | Merck Sharp & Dohme Corp.
    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 [see How Supplied/Storage and Handling (16)].

    2.2 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.

    Hepatic Impairment

    Reduce the starting dose to 300 mg orally once daily with food in patients with mild to moderate hepatic impairment (bilirubin 1 to 3 × ULN or AST > ULN). There is insufficient evidence to recommend a starting dose for patients with severe hepatic impairment (bilirubin > 3 × ULN). [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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