Panobinostat

FARYDAK

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Pronunciation: pan-oe-BIN-oe-stat (FAIR-i-dak)

Panobinostat ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Panobinostat ballicule

What it isHistone deacetylase inhibitor; multiple myeloma (US approval 2015, withdrawn 2022).

Why this oneIt adds an epigenetic mechanism to proteasome inhibition in refractory disease.

What limits itSevere diarrhea and cardiac arrhythmia, including QT prolongation. Thrombocytopenia. Its US approval was withdrawn in March 2022.

Panobinostat molecular structure (skeletal formula) — Molecular structure: Panobinostat

Panobinostat prescription history

Animated chart of estimated U.S. prescriptions per year, Meds eventually withdrawn (1950–2026). Panobinostat enters in 2015 (estimated).

FDA-approved for

multiple myeloma, with bortezomib and dexamethasone (US approval withdrawn 2022) (2015)

Classes and tags

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability1 / 4

QT / Torsades4 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Defining liabilitySevere diarrhea, cytopenias, bleeding and cardiac toxicity

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Fatal and serious toxicities: severe diarrhea (25%) and severe/fatal cardiac ischemic events, arrhythmias, and ECG changes; monitor and manage.

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.

US approval withdrawn 2022 (FARYDAK discontinued); regimen from the withdrawn label. 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

Available strengths

cap 10, 15, 20 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.

Cost

Panobinostat (FARYDAK)

Strength		#/mo	CostPlus
10 mg	cap	per unit	not offered
15 mg	cap	per unit	not offered
20 mg	cap	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Panobinostat is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

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Self-check

Panobinostat: What additional mechanism does it bring to refractory myeloma therapy?
Epigenetic action.
Panobinostat: Which severe GI toxicity limits use?
Diarrhea.