Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

date: 03/08/2021

The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

The company Roche, holder of the marketing authorisation for the medicinal product RoActemra (toculizimab), has informed the FAMHP that supply problems may occur between July and the end of December 2021. The current production capacity is insufficient to meet demands and the stock will be centrally managed. That way the firm tries to limit the unavailability per country to one month.

Belgium should anticipate unavailability of the subcutaneous forms (pen and pre-filled syringe) from the beginning of August until the beginning of September 2021. Until the medicinal product RoActemra becomes available again in sufficient quantities, the FAMHP, upon consultation with experts from the Unavailability Task Force, issues recommendations to (hospital) pharmacists, general practitioners and physician specialists.

Prioritisation of certain indications, in order of priority:

  1. Cytokine Release Syndrome (CRS) following CAR T-cell therapy;
  2. Giant Cell Arteritis (GCA);
  3. Active systemic juvenile idiopathic arthritis (sJIA);
  4. Juvenile idiopathic polyarthritis (pJIA).

Adjustment of the treatment schedule in rheumatoid arthritis:
the treating physician decides for each patient based on the assessed risk for the individual patient and the expected efficacy and side effects of the treatment.

•    In new patients: starting with an alternative medicinal product.
•    For the subcutaneous form: extension of the interval between two administrations in stable patients.
•    For the intravenous form: dose reduction in stable patients.
•    Switch from the subcutaneous form to the intravenous form. This requires the treating physician to create a new application via the Tool for Administrative Reimbursement Drug Information Sharing (TARDIS).

The FAMHP closely monitors the situation, both at national and European level.

Last updated on 03/08/2021