Farydak

With bortezomib and dexamethasone for multiple myeloma after 2+ prior regimens including bortezomib and an IMiD.

20 mg orally every other day for 3 doses per week (Days 1,3,5) during Weeks 1-2 of each 21-day cycle. Up to 16 cycles.

Capsules: 10 mg, 15 mg, 20 mg

None listed in the prescribing information.

• Diarrhea: Severe including fatal cases. Manage aggressively.
• Cardiac Toxicity: Arrhythmias and QTc prolongation. Monitor ECGs.
• Hemorrhage: Severe hemorrhage reported.
• Hepatotoxicity: Monitor liver function.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Diarrhea (68%), Thrombocytopenia (67%), Fatigue (60%), Nausea (36%), Peripheral Edema (29%), Decreased Appetite (28%), Pyrexia (26%), Vomiting (26%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Strong CYP3A4 Inhibitors: Reduce dose to 10 mg.
CYP2D6 Substrates: Panobinostat inhibits CYP2D6; avoid sensitive substrates.
QTc Prolonging Drugs: Avoid.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Panobinostat is a non-selective HDAC inhibitor. Inhibition of HDAC activity leads to hyperacetylation, cell cycle arrest, and apoptosis in malignant cells including myeloma cells resistant to other therapies.

Tmax: 2 hours. Protein binding: ~90%. Half-life: ~37 hours. Elimination: feces 44-77%, urine 29-51%.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• PANORAMA 1 — Panobinostat + Vd vs placebo + Vd in relapsed MM. Phase III, n=768.
  🔬 NCT01023308 ↗ 📄 Primary Publication ↗

Farydak has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: