The Australian Rheumatology Association has released a statement in conjunction with the TGA providing detailed advice on the management of patients with tocilizumab during the next few months of product shortages.
With global supplies of the anti-IL-6 receptor monoclonal antibody under pressure due to the drug’s approval by WHO for use in critically ill patients with COVID-19, the ARA has provided a series of recommendations on how to minimise the impact of shortages on patients with rheumatological conditions.
The TGA website states that availability of tocilizumab may be an issue for patients with RA, giant cell arteritis (GCA), systemic or polyarticular juvenile idiopathic arthritis (JIA) and cytokine release syndrome (CRS).
The statement notes that there may be shortages of various IV formulations of tocilizumab until January 2022, and for the 6 weeks there will be shortages of the SC pre-filled syringe and pre-filled pen autoinjectors.
“Whilst there are shortages of various Actemra intravenous (IV) strengths, Roche have advised there will be overall sufficient supply of other Actemra IV strengths for hospitals for the normal usage for the above indications. Roche does not expect there to be a patient level shortage of Actemra IV,” it says.
According to the ARA advice on patient management, clinicians should review the shortage dates for each formulation and then review their potentially affected patients who may be receiving tocilizumab.
It recommends that prescribers should consider reducing the frequency of tocilizumab SC dose where appropriate, although not for CRS patients.
Similarly, prescribers are advised to delay initiating any new patients on tocilizumab, except where no alternatives or no suitable alternatives are available, such as for GCA, CRS or systemic JIA.
The statement also provides advice on switching between different formulations and suggests that patients using subcutaneous presentations be shown how to use both the pre-filled syringe and pre-filled pen autoinjector in case they need to be switched.
For patients with RA, the advice states that prescribers should consider reducing the frequency of tocilizumab SC dose from weekly to every two weeks where appropriate to conserve their patient’s supply.
“Reduction in frequency for a short period is expected to have minimal impact on patients who are stabilised on tocilizumab SC,” it says.
For IV formulations, prescribers should consider the current supply constraints of various tocilizumab IV strengths, and be prepared to use other strengths to make up a patient’s appropriate dose.
Meanwhile the TGA says the availability of tocilizumab in Australia for off-label treatment of COVID-19 is under review.
“The Medicine Availability Working Group, consisting of the TGA and state and territory representatives, is working with Roche to assess stock levels and model availability and distribution of tocilizumab for use in the treatment of hospitalised COVID-19 patients,” it said.
“The Medicine Availability Working Group is continuing to assess and monitor availability to ensure distribution is prioritised to those hospitals with COVID-19 patients.”