WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment...+
FARYDAK® (panobinostat) capsules may help turn on tumor suppression in multiple myeloma1,2
An HDAC inhibitor, FARYDAK may help turn on tumor suppressor genes through epigenetic changes1
Clinical significance of in vitro data has not been established.
1. FARYDAK [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Atadja P. Development of the pan-DAC inhibitor panobinostat (LBH589): successes and challenges. Cancer Lett. 2009;280(2):233-241. 3. Mithraprabhu S, Kalff A, Chow A, Khong T, Spencer A. Dysregulated class I histone deacetylases are indicators of poor prognosis in multiple myeloma. Epigenetics. 2014;9(11):1511-1520. 4. Glozak MA, Seto E. Histone deacetylases and cancer. Oncogene. 2007;26(37):5420-5432. 5. Maiso P, Carvajal-Vergara X, Ocio EM, et al. The histone deacetylase inhibitor LBH589 is a potent antimyeloma agent that overcomes drug resistance. Cancer Res. 2006;66(11):5781-5789. 6. De Bruyne E, Bos TJ, Schuit F, et al. IGF-1 suppresses Bim expression in multiple myeloma via epigenetic and posttranslational mechanisms. Blood. 2010;115(12):2430-2440. 7. Ocio EM, Vilanova D, Atadja P, et al. In vitro and in vivo rationale for the triple combination of panobinostat (LBH589) and dexamethasone with either bortezomib or lenalidomide in multiple myeloma. Haematologica. 2010;95(5):794-803.
FARYDAK® (panobinostat) capsules, 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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