It has demonstrated a strong safety profile and is currently used for non-therapeutic experimental applications only
Pilie, PG, Giuliani, V, Wang, W, McGrail, DJ, Bristow, C, Ngoi, NY, Kyewalabye, K, Wani, K, Le, H, Campbell, E, Snchez, N, Yang, D, Gheeya, J, Goswamy, R, Holla, V, Shaw, KR, Meric-Bernstam, F, Liu, CY, Ma, X, Feng, N, Machado, AA, Bardenhagen, J, Vellano, CP, Marszalek, JR, Rajendra, E, Piscitello, D, Johnson, TI, Likhatcheva, M, Elinati, E, Majithiya, J, Neves, J, Grinkevich, V, Ranzani, M, Luzarraga, MR, Boursier, M, Armstrong, L, Geo, L, Lillo, G, Tse, WY, Lazar, A, Kopetz, S , Do, MK, Lively, S, Johnson, MG, Robinson, HM, Smith, GC, Carroll, C, Di, MF, Jones, PH, Heffernan, TP, Yap, TA
The compound should be avoided during these periods unless specifically recommended by a qualified healthcare provider after careful risk-benefit assessment
Jan 14 2014;111(1):151-159
For off-label clinical use, it must come from a licensed 503A compounding pharmacy that manufactures under pharmaceutical-grade conditions with documented sterility testing, potency verification, and third-party quality standards