HDAC inhibitor Pregnancy: The likelihood of increasing the risk of both foetal death and developmental skeletal abnormalities when given to pregnant women is predicted to be high, based on animal findings. Women of childbearing potential must have a pregnancy test before starting and use a highly effective method of contraception during treatment and for 3 months after the last dose (adding a barrier method if using hormonal contraceptives). Sexually active men and their female partners should use a highly effective method of contraception during treatment and for 6 months after the man's last dose. Breast-feeding is contraindicated.

Panobinostat (Specialist drug)

Brand names: Farydak

Panobinostat is a specialist oral histone deacetylase inhibitor used in combination therapy for relapsed or refractory multiple myeloma.

Adult dose

Dose: 20 mg (recommended starting dose), in combination with bortezomib and dexamethasone

Route: Oral. Capsules must be swallowed whole with water, with or without food - do not open, crush or chew

Frequency: Once a day on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle (2 weeks on, 1 week rest)

Treatment should be initiated by a physician experienced in the use of anti-cancer therapies. Patients should be treated initially for eight cycles; those with clinical benefit should continue for eight additional cycles, to a total of up to 16 cycles (48 weeks). COMBINATION PARTNERS: bortezomib 1.3 mg/m2 as an injection and dexamethasone 20 mg orally on a full stomach. Cycles 1-8 schedule: panobinostat days 1, 3, 5, 8, 10, 12; bortezomib days 1, 4, 8, 11; dexamethasone days 1, 2, 4, 5, 8, 9, 11, 12; week 3 rest. Cycles 9-16 schedule: panobinostat days 1, 3, 5, 8, 10, 12; bortezomib days 1, 8; dexamethasone days 1, 2, 8, 9; week 3 rest. Consult the bortezomib and dexamethasone prescribing information before starting to assess whether their doses need reducing. DOSE REDUCTION: reduce in 5 mg decrements (20 mg to 15 mg, 15 mg to 10 mg); do not reduce below 10 mg and keep the same 3-week cycle. Baseline platelet count must be at least 100 x 10^9/L and absolute neutrophil count at least 1.0 x 10^9/L before starting, and platelets at least 100 x 10^9/L before each cycle. Record an ECG before starting and periodically before each cycle - QTcF must be below 480 msec before initiation; omit the dose if QTcF reaches 480 msec or rises more than 60 msec from baseline, and discontinue permanently if any QTcF value exceeds 500 msec. Correct potassium, magnesium and phosphorus abnormalities before and during treatment. HEPATIC IMPAIRMENT: mild - start at 15 mg in the first cycle (escalation to 20 mg may be considered); moderate - start at 10 mg in the first cycle (escalation to 15 mg may be considered) and reduce bortezomib to 0.7 mg/m2; severe - must not be administered. Patients over 75 years: panobinostat may be started at 15 mg escalating to 20 mg in the second cycle if tolerated, with bortezomib 1.3 mg/m2 once weekly on days 1 and 8 and dexamethasone 20 mg on days 1 and 8. Missed dose: may be taken up to 12 hours after the specified dose time; if vomiting occurs do not take an additional dose. No relevant use in patients below 18 years for multiple myeloma.

Dose adjustments

Renal

Plasma exposure is not altered in cancer patients with mild to severe renal impairment, so starting dose adjustments are not necessary. Not studied in end-stage renal disease or in patients on dialysis.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Breast-feeding

Side effects

Diarrhoea (very common; may require dose interruption or reduction)
Fatigue and asthenia
Nausea and vomiting
Thrombocytopenia (dose-limiting), anaemia, neutropenia and lymphopenia
QTc prolongation and cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, sinus tachycardia) in 17.6%; syncope in 6.0%
Mild hypothyroidism

Interactions

Strong CYP3A and/or P-glycoprotein inhibitors (including ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone): reduce the panobinostat dose to 10 mg; if continuous treatment with the inhibitor is required, escalation from 10 mg to 15 mg may be considered based on tolerability. Avoid altogether in patients with hepatic impairment. Do not start a strong CYP3A inhibitor in patients already dose-reduced for adverse reactions
Dexamethasone (a weak to moderate CYP3A4 inducer) given as part of the regimen: consider the risk of reduced efficacy of hormonal contraceptives; women using hormonal contraceptives should additionally use a barrier method
This interaction list may be incomplete — check the full SPC.

Clinical monograph

How it works

It inhibits histone deacetylase enzymes, leading to accumulation of acetylated proteins, altered gene expression, cell-cycle arrest and apoptosis in malignant cells.

Prescribing in practice

It can cause severe and potentially fatal cardiac arrhythmias and QT prolongation as well as severe diarrhoea, so an ECG and electrolytes must be checked and corrected before and during treatment.
Severe thrombocytopenia and other cytopenias are common and require blood count monitoring with dose modification.
It is metabolised by CYP3A4, so avoid concurrent strong CYP3A4 inhibitors and inducers.

Monitoring

Monitor ECG, electrolytes including potassium and magnesium, and full blood count before and during each cycle.

Counselling the patient

Report palpitations, fainting, severe diarrhoea or unusual bruising and bleeding promptly.
Avoid grapefruit and tell your team about all other medicines you take.

Evidence & guidelines

Approval was supported by the PANORAMA 1 trial in combination with bortezomib and dexamethasone for multiple myeloma.

Reference: NICE TA380; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways