Navas, NataliaHermosilla, JesúsTorrente-López, AnabelHernández-Jiménez, JoséCabeza, JosePérez-Robles, RaquelSalmerón-García, Antonio2022-03-302022-03-302020-12Navas N, Hermosilla J, Torrente-López A, Hernández-Jiménez J, Cabeza J, Pérez-Robles R, Salmerón-García A. Use of subcutaneous tocilizumab to prepare intravenous solutions for COVID-19 emergency shortage: Comparative analytical study of physicochemical quality attributes. J Pharm Anal. 2020 Dec;10(6):532-5452095-1779http://hdl.handle.net/10668/3505COVID-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 COVID-19. 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/COVID-19TocilizumabCritical quality attributesIV and SC medicinesSíndrome de liberación de citoquinasSARS-CoV-2Preparaciones farmacéuticasCytokine release syndromeMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, HumanizedMedical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Intercellular Signaling Peptides and Proteins::Cytokines::Interleukins::Interleukin-6Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Prescriptions::Off-Label UseMedical Subject Headings::Health Care::Environment and Public Health::Public Health::Disease Outbreaks::Epidemics::PandemicsMedical Subject Headings::Health Care::Environment and Public Health::Public HealthMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::SyringesMedical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health Facilities::HospitalsMedical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparationsresearch article32837741open access10.1016/j.jpha.2020.06.0032214-0883PMC7319620