Covid and cures, tocilizumab demand boom: shortage until December

After its use in the treatment for Covid, there is a boom in applications for the monoclonal antibody tocilizumab which, explains Aifa, will suffer a temporary shortage until almost the end of December. “A temporary shortage in Italy is expected in the supply” of the monoclonal antibody in the intravenous formulation only (not for the subcutaneous one). The problem has been ongoing since mid-September. And “the refueling is expected by 21 December”. The Italian Medicines Agency had already reported this through the words of the director general, Nicola Magrini. Now he writes it in an ‘Important Information Note’, an official communication, issued because the shortage of the drug – for which “global demand has increased at an unprecedented rate”, being used now “also for the treatment of hospitalized adult patients with severe Covid or with high levels of systemic inflammation indices “- implies problems for patients with various pathologies under treatment. “In case of lack of supply – explains Aifa – the interruption of treatment could lead to the occurrence of a relapse (increase in the activity of the disease / worsening of symptoms)”. Indeed, the regulatory body provides “therapeutic options to mitigate any potential risk of relapse during this period”. These are patients suffering from rheumatoid arthritis, juvenile idiopathic poly-articular arthritis, systemic juvenile idiopathic arthritis. Aifa therefore invites healthcare professionals to re-evaluate the general conditions and the risk of relapse of patients in case they interrupt therapy and, in the presence of this risk, to intervene following various possible ways, listed in the note. with rheumatoid arthritis “treatment with subcutaneous sarilumab was also authorized” and “it is necessary to establish the appropriateness of the conditions for switching to this therapy”. In the event that the intravenous therapy is exhausted, the indication given by Aifa is to start one based on tocilizumab under the skin already from the next scheduled dose of intravenous solution. Upon resolution of the supply shortage, intravenous tocilizumab therapy may be reintroduced approximately 2 weeks after the last subcutaneous injection. Specialists treating these patients will therefore have to assess their general state of health, “the treatment regimen” they follow and “the potential risk of a relapse if doses of RoActemra * are skipped for the duration of the shortage. , equal to 14 weeks “, ie from 16 September to 21 December. And then on the basis of this to choose the path to follow, given that for patients at risk of relapse, as explained, “alternative treatments are available”. For Car-T-cell-induced cytokine release syndrome (Crs), the agency adds, “because only intravenous tocilizumab has been approved for this condition, the company is committed to ensuring its supply. In some circumstances, patients they may have to go to the hospital / clinic of reference for the administration of an alternative treatment “. As for Covid patients for whom the drug is used, the path chosen by AIFA was the evaluation of the possible authorization of alternative treatments.