@misc{10481/66087,
year = {2020},
url = {http://hdl.handle.net/10481/66087},
abstract = {COVID-19, a disease caused by the novel coronavirus SARS-CoV-2, has produced a serious emergency for
global public health, placing enormous stress on national health systems in many countries. Several
studies suggest that cytokine storms (interleukins) may play an important role in severe cases of COVID19. Neutralizing key inflammatory factors in cytokine release syndrome (CRS) could therefore be of great
value in reducing the mortality rate. Tocilizumab (TCZ) in its intravenous (IV) form of administration
-RoActemra® 20 mg/mL (Roche)-is indicated for treatment of severe CRS patients. Preliminary investigations have concluded that inhibition of IL-6 with TCZ appears to be efficacious and safe, with
several ongoing clinical trials. This has led to a huge increase in demand for IV TCZ for treating severe
COVID-19 patients in hospitals, which has resulted in drug shortages. Here, we present a comparability
study assessing the main critical physicochemical attributes of TCZ solutions used for infusion, at 6 mg/
mL and 4 mg/mL, prepared from RoActemra® 20 mg/mL (IV form) and from RoActemra® 162 mg (0.9 mL
solution pre-filled syringe, subcutaneous(SC) form), to evaluate the use of the latter for preparing clinical
solutions required for IV administration, so that in a situation of shortage of the IV medicine, the SC form
could be used to prepare the solutions for IV delivery of TCZ. It is important to remember that during the
current pandemic all the medicines are used off-label, since none of them has yet been approved for the
treatment of COVID-19.},
organization = {Instituto Carlos III, Ministerio de Economia y Competitividad, Spain 	
FIS: PI-17/00547},
organization = {European Union (EU)},
organization = {Ministry of Universities, Spain 	
FPU18/03131},
organization = {University of Granada (Spain)},
publisher = {ELSEVIER},
keywords = {COVID-19},
keywords = {Tocilizumab},
keywords = {Critical quality attributes},
keywords = {IV and SC medicines},
title = {Use of subcutaneous tocilizumab to prepare intravenous solutions for COVID-19 emergency shortage: Comparative analytical study of physicochemical quality attributes},
doi = {10.1016/j.jpha.2020.06.003},
author = {Navas Iglesias, Natalia Africa and Hermosilla, Jesús and Torrente López, Anabel and Hernández Jiménez, José and Cabeza, José and Pérez Robles, Raquel and Salmerón García, Antonio},
}