panobinostat lactate anhydrous: clinical use

Prescribing considerations

• Initiation and supervision should be by clinicians experienced in anticancer therapy.
• Do not initiate during an active infection; treat pre-existing infection first.
• Assess bleeding and cardiac risk, gastrointestinal toxicity, hepatic impairment and interacting medicines.
• Older adults may require closer surveillance for thrombocytopenia and gastrointestinal toxicity.
• Panobinostat has not been evaluated for this indication in people under 18 years or adequately studied in end-stage renal disease or dialysis.

Contraindications and cautions

• Hypersensitivity to panobinostat or a listed excipient
• Breastfeeding

Monitoring

• Full blood count, particularly platelets and neutrophils
• ECG and cardiac-risk assessment
• Potassium, magnesium and phosphate
• Liver function
• Hydration and gastrointestinal toxicity
• Clinical signs of infection and bleeding
• Pregnancy testing where relevant

Clinical pharmacology

Panobinostat is a pan-histone deacetylase inhibitor and P-glycoprotein substrate. Metabolism uses non-CYP pathways and CYP3A4, with minor CYP2D6 and CYP2C19 involvement.

Formulation and product differences

• The selected product is an oral hard gelatin capsule containing panobinostat lactate anhydrous equivalent to panobinostat.
• Capsules must remain intact and stored in their original packaging below 30°C to protect from moisture.
• The formulation contains mannitol, gelatin and colourants; check the full excipient list where allergy or intolerance is relevant.

Capsule

Route: Oral

Strengths: 10 mg, 15 mg, 20 mg