Ofatumumab▼: reminder of risk of serious and fatal infusion reactions

Serious and fatal infusion reactions have occurred with ofatumumab and other anti-CD20 monoclonal antibodies. We remind you to always give premedication before each ofatumumab infusion. If a severe reaction occurs, interrupt ofatumumab infusion and treat the reaction.

Article date: August 2014

Ofatumumab▼ (Arzerra▼) is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) refractory to fludarabine and alemtuzumab.

Infusion reactions have occurred with intravenous ofatumumab. A fatal infusion reaction has occurred during administration of the first dose of ofatumumab to a 71 year old man.

We remind you of the recommendations to reduce the risk of infusion reactions with ofatumumab:

Advice for healthcare professionals:

  • Ofatumumab should only be given under the supervision of a physician experienced in the use of cancer therapy and where facilities to monitor and treat infusion reactions are available
  • Always give patients premedication 30 minutes to 2 hours before each ofatumumab infusion according to the protocol in the summary of product characteristics (see further information below)
  • Despite premedication, infusion reactions may still occur
  • If an infusion reaction occurs, interrupt ofatumumab infusion immediately and treat the symptoms of the reaction
  • Patients with a history of decreased pulmonary function may be at a high risk of pulmonary complications from severe reactions. Monitor these patients closely during ofatumumab infusion.

Infusion reactions have also occurred with other anti-CD20 monoclonal antibodies such as rituximab (MabThera) and obinutuzumab (Gazyvaro). Specific recommendations to reduce the risk of infusion reactions for each of these products, including the use of pre-medications, are in the summary of product characteristics for each product (see further information below).

Further information

Summaries of product characteristics

Letter sent to healthcare professionals in July 2014

Article citation: Drug Safety Update volume 8 issue 1, August 2014: A2.

Published 11 December 2014