伏立诺他胶囊（Zolinza）

[Function and indications] On October 26, 2006, the U.S. Food and Drug Administration (FDA) approved Zolinza (vorinostat capsules) for the treatment of skin manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressed, persisted, or relapsed disease after two systemic therapies or after.

[Model and specifications]
Capsule: 100 mg

[Usage and Dosage]
(1) 400 mg orally once a day with food.
(2) If the patient cannot tolerate the treatment, the dose may be reduced to 300 mg orally once a day with food. If necessary, the dose may be further reduced to 300 mg once a day with food for 5 consecutive days per week.

[Precautions]
(1) Pulmonary embolism and deep vein thrombosis have been reported. Monitor patients for relevant signs and symptoms.
(2) Dose-related thrombocytopenia and anemia have occurred and may require dose adjustment or discontinuation.
(3) Gastrointestinal dysfunction (e.g., nausea, vomiting, and diarrhea) has been reported. Patients may require antiemetics, antidiarrheals, and fluid and electrolyte replacement (to prevent dehydration).
(4) Patients with mild and moderate hepatic impairment should be treated with caution.
(5) Hyperglycemia has been observed. Adjust diet and/or treatment of increased glucose may be required.
(6) Monitor electrolytes at baseline and regularly during treatment.
(7) Monitor blood counts and chemistry tests, including electrolytes, glucose, and serum creatinine, every 2 weeks during the first 2 months of treatment and monthly thereafter.
(8) Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Monitor platelet counts.
(9) Fetal harm may occur when administered to pregnant women. Women should be advised of the potential harm to the fetus.

[Adverse Reactions]
Common adverse reactions (incidence ≥ 20%) are diarrhea, fatigue, nausea, thrombocytopenia, loss of appetite, and taste disturbances.

[Contraindications]
Severe liver damage

[Use in pregnant women]
ZOLINZA may cause fetal harm when administered to a pregnant woman. It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ZOLINZA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

[Use in children]
The safety and effectiveness of ZOLINZA in pediatric patients have not been established.

【Drug Interactions】
Coumarin derivative anticoagulants: Concomitant use has been observed to prolong prothrombin time and international normalized ratio. Monitor carefully