Farydak,帕比司他 panobinostat 原研参比制剂;一次性进口/平价代购： 10mg/15mg /20mg
FARYDAK 10MG CAP BLIST PACK 6/EA PANOBINOSTAT NOVARTIS 00078-0650-06
FARYDAK 15MG CAP BLIST PACK 6/EA PANOBINOSTAT NOVARTIS 00078-0651-06
FARYDAK 20MG CAP BLIST PACK 6/EA PANOBINOSTAT NOVARTIS 00078-0652-06
FARYDAK推荐剂量为：
（1）20mg口服，每周期的第1、3、5、8、10、12天用药，21天为一个周期，共8个治疗周期。
（2）若患者能临床获益，没有严重的持续毒副反应，此时可考虑继续另外8个周期的治疗。
完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7774972a-eeaa-4b9a-9e56-3fc1b968e86a
FARYDAK(panobinostat capsules)
FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Farydak Description
FARYDAK (panobinostat lactate) is a histone deacetylase inhibitor.
The chemical name of panobinostat lactate is 2-Hydroxypropanoic acid, compd. with 2-(E)-N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2-propenamide (1:1).
The structural formula is:
Panobinostat lactate anhydrous is a white to slightly yellowish or brownish powder. The molecular formula is C21H23N3O2?C3H6O3 (lactate); its molecular weight is 439.51 (as a lactate), equivalent to 349.43 (free base). Panobinostat lactate anhydrous is light sensitive. Panobinostat lactate anhydrous is both chemically and thermodynamically a stable crystalline form with no polymorphic behavior. Panobinostat free base is not chiral and shows no specific optical rotation. Panobinostat lactate anhydrous is slightly soluble in water. Solubility of panobinostat lactate anhydrous is pH-dependent, with the highest solubility in buffer pH 3.0 (citrate).
FARYDAK capsules contain 10 mg, 15 mg, or 20 mg panobinostat free base. The inactive ingredients are magnesium stearate, mannitol, microcrystalline cellulose and pregelatinized starch. The capsules contain gelatin, FD&C Blue 1 (10 mg capsules), yellow iron oxide (10 mg and 15 mg capsules), red iron oxide (15 mg and 20 mg capsules) and titanium dioxide.
FARYDAK capsules are packaged in PVC/PCTFE blister packs.
10mg blister packs containing 6 capsules………………………….……..NDC 0078-0650-06
15mg blister packs containing 6 capsules ………………………….…….NDC 0078-0651-06
20mg blister packs containing 6 capsules ………………………….…….NDC 0078-0652-06. |
