Active Ingredient: Panobinostat
Panobinostat, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
20 - 20 mg
From 20 To 20 mg once every 2 day(s) for 12 day(s)
The recommended starting dose of panobinostat is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12 of a 21-day cycle. Patients should be treated initially for eight cycles. It is recommended that patients with clinical benefit continue the treatment for eight additional cycles. The total duration of treatment is up to 16 cycles (48 weeks).
Panobinostat is administered in combination with bortezomib and dexamethasone, as shown in Tables 1 and 2. The bortezomib and dexamethasone prescribing information should be consulted prior to the start of the combination treatment to assess whether a dose reduction is required.
The recommended dose of bortezomib is 1.3 mg/m² given as an injection. The recommended dose of dexamethasone is 20 mg taken orally on a full stomach.
Table 1. Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 1-8):
| Cycles 1-8: (3-week cycles) | Week 1 Days | Week 2 Days | Week 3 | ||||||||||||
| panobinostat | 1 | 3 | 5 | 8 | 10 | 12 | Rest period | ||||||||
| Bortezomib | 1 | 4 | 8 | 11 | Rest period | ||||||||||
| Dexamethasone | 1 | 2 | 4 | 5 | 8 | 9 | 11 | 12 | Rest period | ||||||
Table 2. Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 9-16):
| Cycles 9-16: (3-week cycles) | Week 1 Days | Week 2 Days | Week 3 | ||||||||||||
| panobinostat | 1 | 3 | 5 | 8 | 10 | 12 | Rest period | ||||||||
| Bortezomib | 1 | 8 | Rest period | ||||||||||||
| Dexamethasone | 1 | 2 | 8 | 9 | Rest period | ||||||||||
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