Rheumatoid arthritis

TGA issues urgent advice to restrict off-label use of tocilizumab in COVID-19 treatment


In a follow-up to last week’s warning about critical shortages of tocilizumab for rheumatological conditions, the TGA has issued urgent advice for conservation of tocilizumab when used off-label for COVID-19 treatment.

The TGA now advises clinicians to use only one dose of tocilizumab rather than two as previously suggested. And given the critical shortage of intravenous forms of  tocilizumab, it advises clinicians to consider using oral baricitinib rather than tocilizumab in eligible patients.

The TGA says it has advised the National COVID-19 Clinical Evidence Taskforce of the shortages, and in response the Taskforce  has revised its recommendations to state that:

  • the second dose of tocilizumab be considered in light of availability; and
  • in patients who are receiving supplemental oxygen, but who are not mechanically ventilated, baricitinib should be considered as an alternative unless contraindicated.

However the TGA’s Medicine Availability Working Group (MAWG) goes furthetr, with the following criteria for treatment of hospitalised COVID-19 patients:

  • baricitinib (Olumiant) should be used instead of tocilizumab when considered for patients who are receiving supplemental oxygen but are not mechanically ventilated.
  • intravenous tocilizumab should be reserved for patients with COVID-19 when baricitinib is not clinically appropriate.
  • when used for COVID-19 patients only one dose of intravenous tocilizumab should be administered.

The TGA adds that MAWG is working with Roche to monitor availability of tocilizumab, and ensure that  distribution is prioritised to those hospitals with COVID-19 patients.

“While treatment of COVID-19 is not a registered indication for tocilizumab or baricitinib in Australia these products have been conditionally recommended for use in certain hospitalised patients with COVID-19 by the National COVID-19 Clinical Evidence Taskforce,” the TGA notes.

“Current forecasts and the uncertainty of global supply indicate the need to urgently conserve tocilizumab to support ongoing access for people hospitalised with COVID-19 for whom baricitinib is not suitable, including:

• Special patient groups (pregnant women, adolescents, children)

• Patients who cannot be administered medications via the oral/nasogastric route

• Patients who are mechanically ventilated.

The TGA also reminds clinicians treating rheumatological conditions to “consider the current shortage of tocilizumab when prescribing, particularly when initiating new patients on treatment for the registered (tocilizumab) Actemra indications.”

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