VORINOSTAT CAP,ORAL
Clinical Criteria Summary
Indication
- Cutaneous T-cell Lymphoma (CTCL)
Inclusion Criteria
- Stage histological diagnosis of CTCL with advanced disease documented as Stage IIb or higher including Sézary syndrome
- Documented contraindication or treatment failure of radiotherapy, total skin electron beam therapy, no PUVA, or extracorporeal photopheresis
- Documented current or prior treatment or treatment failure of interferon-alpha and oral bexarotene
- Age > 18 years
- Ability to swallow capsules
- Adequate hepatic, renal, and hematological function at baseline
- Prior chemotherapy has been discontinued for at least 3 weeks and the patient has recovered from toxicities of prior therapy; exception in patients with rapidly progressing disease who should be considered for therapy on an individual basis
Exclusion Criteria
- Hypersensitivity to vorinostat
- Pregnant women or women intending to become pregnant (Pregnancy Category D)
- Use for other indications (such as for colorectal cancer) or in combination with other chemotherapeutic agents is not recommended at this time due to insufficient evidence
Dosing
- 400 mg orally once daily with food
- For those intolerant to therapy, dose can be reduced to 300 mg daily or further to 300 mg for 5 consecutive days each week
Monitoring
- Severe thrombocytopenia and gastrointestinal bleeding (reported with concomitant use of vorinostat and other HDAC inhibitors like valproic acid): Monitor platelet count every 2 weeks during the first 2 months
- Thrombocytopenia and anemia: Doses should be modified or therapy discontinued according to any reductions in platelet counts and/or hemoglobin
- Discuss appropriate methods of contraception
- Pre-existing nausea, vomiting, and diarrhea should be adequately controlled before beginning therapy
- Hypokalemia or hypomagnesemia should be corrected prior to administration; potassium and magnesium should be considered in patients with nausea, vomiting, diarrhea, fluid imbalance or cardiac symptoms
- QTc prolongation has been reported; close monitoring should occur particularly among patients taking drugs known to prolong the QTc interval
- Pulmonary embolism and deep vein thrombosis have been reported; physicians should be alert to signs and symptoms, particularly in patients with a prior history of thromboembolic events
- Prolongation of prothrombin time and increased INR has occurred among some patients taking vorinostat and warfarin concomitantly
- Serum glucose should be monitored, especially in diabetic patients; adjustment of diet and/or therapy may be necessary
Discontinuation
- Vorinostat is given until disease progression or intolerance to therapy occurs