Vorinostat
ZOLINZA
What it isHistone deacetylase inhibitor; cutaneous T-cell lymphoma.
Why this oneOral epigenetic therapy for a disease with few systemic options.
What limits itThrombocytopenia, fatigue and QT prolongation. Dehydration from GI losses is common.
FDA-approved for
- cutaneous T-cell lymphoma (2006)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Cutaneous T-cell lymphoma (CTCL) | adult | 400 mg QD | 400 mg QD | 400 mg QD |
Renal Undefined
Hepatic Mild-moderate (bilirubin 1-3×ULN or AST>ULN): reduce to 300 mg QD; severe: insufficient data
For intolerance, may reduce to 300 mg QD, then 300 mg QD for 5 consecutive days/week
Instructions
- Take with food
- Swallow whole; do not open or crush capsules
- Effective contraception during and after treatment (females 6 mo, males 3 mo)
- Drink ≥2 L/day fluids to prevent dehydration
Cautions
- Thromboembolism (PE, DVT)
- Myelosuppression (thrombocytopenia, anemia) — monitor CBC
- GI toxicity (nausea, vomiting, diarrhea); prevent dehydration
- Hyperglycemia — monitor glucose
- Electrolyte/creatinine abnormalities — monitor and correct
- Severe thrombocytopenia with concomitant HDAC inhibitors (e.g., valproic acid)
- Embryo-fetal toxicity
Adverse reactions
- Diarrhea
- Fatigue
- Nausea
- Thrombocytopenia
- Anorexia
- Dysgeusia
Pregnancy Can cause fetal harm; advise of potential risk to fetus
Lactation Do not breastfeed during and for ≥1 week after last dose
NO BOXED WARNINGS
Principal riskThrombocytopenia and QT prolongation
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entry2027 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryD
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Vorinostat ballicule
