Dear Healthcare professional letter on the risk of serious and life-threatening infusion reactions during the use of ofatumumab (Arzerra)
28.07.2014
GlaxoSmithKline d.o.o. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals to remind them of the risk of serious and lifethreatening infusion reactions during use of ofatumumab.
Summary
A fatal infusion reaction has been documented during the first dose of ofatumumab in a 71 year old patient with chronic lymphocyte leukemia (CLL), without known heart diseases.
Recommendations for healthcare professionals
- Ofatumumab may be given only under supervision of a doctor experienced in anticancer therapy in a setting where infusion reactions may be monitored and treated.
- Patients should receive a pre-medication 30 minutes to 2 h before each ofatumumab infusion, according to the dosing schedule indicated in the Summary of Prooduct Characteristics of Arzerra.
- Infusion reactions may occur in spite of pre-medication. In the case of a severe infusion reaction, the ofatumumab infusion must be stopped immediately and the symptomatic therapy started.
Further information
Ofatumumab is indicated for the treatment of chronic lymphocytic leukemia (CLL) in patients non-reactive to fludarabin and alemtuzumab. The intravenous use of ofatumumab is associated with the risk of potentially fatal infusion reactions.
Healthcare professionals should inform patients about the risk of potentially fatal reactions associated with the infusion of ofatumumab. These reactions may occur in spite of a pre-medication, during the first infusion, in particular. There are no changes in the recommended pre-medication regime, however, all healthcare professionals are advised that patients should receive the following pre-medication 30 minutes to 2 h before each ofatumumab infusion:
- oral paracetamol (acetaminophen) 1000 mg (or equivalent) and
- oral or intravenous antihistaminic (diphenhydramine 50 mg or cetirizine 10 mg or equivalent) and
- intravenous corticosteroid (prednisolone 100 mg or equivalent)
In cases of severe infusion reactions the ofatumumab infusion must be immediately stopped and the symptomatic therapy started.
Patients with the history of reduces pulmonary function may be at higher risk for development of lung complications within infusion reactions, therefore those patients should be carefully monitored during the ofatumumab infusion.
HALMED has not received any adverse reaction report to Arzerra that would be associated with infusion reactions. HALMED will continue to closely monitor the safe use of this medicine and will inform the public promptly about any new information.
Here you may view the Dear Healthcare Professional Leter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
