ZOLINZA

Generic Name/API: vorinostat capsules, for oral use

Manufacturer: Merck Sharp & Dohme LLC

Dosage Forms & Strength & Pack Size:
Capsule, 100 mg, 120’s

Storage:
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. 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 [see Nonclinical Toxicology (13.1)].

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
ZOLINZA is a 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 on or following two systemic therapies.

What is ZOLINZA?
ZOLINZA is a prescription medicine for a type of cancer called cutaneous T-cell lymphoma (CTCL), which is a blood cell cancer that affects your skin. ZOLINZA is used when your CTCL gets worse, does not go away, or comes back after you have taken other medicines.

WARNINGS AND PRECAUTIONS
Thromboembolism: Monitor for pertinent signs and symptoms of pulmonary embolism and deep vein
thrombosis. (5.1)
Myelosuppression: Thrombocytopenia and anemia may require dose modification or discontinuation.
Monitor blood counts every 2 weeks during the first 2 months of therapy and monthly thereafter. (2.2,
5.2, 6)
Gastrointestinal Toxicity: Nausea, vomiting and diarrhea; patients may require antiemetics,
antidiarrheals, and fluid and electrolyte replacement to prevent dehydration. (5.3, 6)
Hyperglycemia: Monitor blood glucose every 2 weeks during the first 2 months of therapy and monthly
thereafter. (5.4)
Clinical Chemistry Abnormalities: Measure and correct abnormal electrolytes, creatinine, magnesium
and calcium at baseline. Monitor every 2 weeks during the first 2 months of therapy and at least
monthly during treatment. (5.5)
Severe Thrombocytopenia with Concomitant Use of other HDAC Inhibitors: Severe thrombocytopenia
with gastrointestinal bleeding has been reported with concomitant use of ZOLINZA and other HDAC
inhibitors (e.g., valproic acid). Monitor platelet counts more frequently. (5.6, 7.2)
Embryo-Fetal Toxicity: Fetal harm can occur when administered to a pregnant woman. Women should
be apprised of the potential harm to the fetus. (5.7)

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