Panobinostat
FARYDAK
What it isHistone deacetylase inhibitor; multiple myeloma.
Why this oneIt adds an epigenetic mechanism to proteasome inhibition in refractory disease.
What limits itSevere diarrhea and cardiac arrhythmia, including QT prolongation. Thrombocytopenia; withdrawn in some markets.
FDA-approved for
- multiple myeloma (2015)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Multiple myeloma (relapsed; w/ bortezomib + dexamethasone) | Adults | 20 mg 3×/week (D1,3,5,8,10,12) wks 1–2 of 21-day cycle | 20 mg | 20 mg |
Renal Mild–severe: no adjustment (no effect on exposure); not studied in ESRD/dialysis.
Hepatic Mild: reduce start to 15 mg. Moderate: reduce start to 10 mg. Severe: avoid.
Reduce dose in 5 mg steps (20→15→10); discontinue if <10 mg 3×/week. Up to 16 cycles total. Given with bortezomib + dexamethasone.
Instructions
- Swallow capsules whole with water; do not open, crush, or chew
- Take with or without food at about the same time on each scheduled day
- If a dose is missed, take up to 12 h after scheduled time
- If vomiting occurs, do not repeat the dose; take next scheduled dose
- With strong CYP3A inhibitors, reduce start to 10 mg
Cautions
- Severe diarrhea
- Cardiac toxicities: ischemia, arrhythmias, QT prolongation
- Fatal/serious GI and pulmonary hemorrhage
- Myelosuppression: thrombocytopenia, neutropenia, anemia
- Infections (including fatal)
- Hepatotoxicity
- Embryo-fetal toxicity
Adverse reactions
- Diarrhea, nausea, vomiting, decreased appetite
- Fatigue, peripheral edema, pyrexia
- Labs: thrombocytopenia, lymphopenia, leukopenia, neutropenia, anemia; hypophosphatemia, hypokalemia, hyponatremia, increased creatinine
Pregnancy Can cause fetal harm; teratogenic in rats and rabbits.
Lactation Unknown whether excreted in milk; decide to discontinue nursing or drug.
⚠ BOXED WARNINGS
- Severe diarrhea
- Cardiac toxicity
Classes and tags
Clinical profile
Mechanism of action: Panobinostat ballicule
