Panobinostat is a histone deacetylase (HDAC) inhibitor. It is used in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least 2 prior treatment regimens (including bortezomib and immunomodulatory agents).
How to Use Panobinostat
Administration Regimen
Standard Dosage: The recommended starting dose is 20mg, taken orally every other day for 3 times a week (on Days 1, 3, 5, 8, 10, and 12) during Weeks 1 and 2 of a 21-day treatment cycle. Each cycle lasts 3 weeks, with a maximum of 8 cycles (48 weeks) of treatment.
Combination Therapy: Must be used in combination with bortezomib (1.3mg/m² via injection) and dexamethasone (20mg via oral administration).
Extended Treatment: For patients who achieve clinical benefits and do not experience unresolved severe or medically significant toxicity, an additional 8 cycles of treatment may be considered (maximum total treatment duration of 16 cycles).
Administration Instructions
Method of Taking: Swallow the capsule whole; do not open, crush, or chew the capsule. It can be taken with food or on an empty stomach.
Management of Missed Dose: If a dose is missed, it can be supplemented within 12 hours after the scheduled administration time; if vomiting occurs, no supplementary dose is needed, and the next dose should be taken as planned.
Monitoring Requirements
Complete blood count (CBC) should be monitored regularly before and during treatment to ensure baseline platelets ≥ 100×10⁹/L and absolute neutrophil count (ANC) ≥ 1.5×10⁹/L.
Electrocardiogram (ECG) examination is required before treatment to confirm QTcF < 450ms, and regular re-examinations should be conducted during treatment.
Monitor serum electrolytes (potassium, magnesium, etc.), and correct abnormalities before starting treatment.
Dosage Adjustment of Panobinostat
Thrombocytopenia
Platelets < 50×10⁹/L with bleeding: Discontinue treatment until platelets ≥ 50×10⁹/L, and reduce the dose after recovery.
Platelets < 25×10⁹/L: Discontinue treatment until platelets ≥ 50×10⁹/L, and reduce the dose after recovery.
Neutropenia
ANC < 0.5×10⁹/L: Discontinue treatment until ANC ≥ 1.0×10⁹/L, and reduce the dose after recovery.
Febrile neutropenia: Discontinue treatment immediately.
Diarrhea
Moderate diarrhea (4-6 times/day): Discontinue treatment until remission, then continue with the original dose.
Severe diarrhea (≥7 times/day or requiring intravenous fluid replacement): Discontinue treatment until remission, then reduce the dose.
Life-threatening diarrhea: Discontinue treatment permanently.
Panobinostat Use in Special Populations
Pregnancy and Lactation
Pregnancy: Has embryo-fetal toxicity and may cause malformations. Women of childbearing age should take effective contraceptive measures during treatment and within 1 month after the last dose.
Lactation: Use during lactation is not recommended, and a choice must be made between medication use and lactation.
Hepatic and Renal Impairment
Hepatic Impairment: Dose reduction is required for mild to moderate hepatic impairment; use should be avoided for severe hepatic impairment.
Renal Impairment: No dose adjustment is needed for mild to moderate renal impairment; data on end-stage renal disease (ESRD) is limited.
