According to NICE ( National Institute for Health and Clinical Excellence ) Ofatumumab ( Arzerra ) is not recommended for the treatment of chronic lymphocytic leukaemia that is refractory to Fludarabine ( Fludara ) and Alemtuzumab ( MabCampath ).
People receiving Ofatumumab for the treatment of chronic lymphocytic leukaemia that is refractory to Fludarabine and Alemtuzumab should have the option to continue treatment until they and their clinician consider it appropriate to stop.
Ofatumumab is a fully human, high-affinity monoclonal antibody that is targeted against the CD20 cell surface antigen of B-lymphocytes.
Ofatumumab has a conditional marketing authorisation for the treatment of chronic lymphocytic leukaemia in patients who are refractory to Fludarabine and Alemtuzumab.
Ofatumumab is delivered by intravenous infusion. The recommended dose is 300 mg of Ofatumumab for the first infusion and 2000 mg of Ofatumumab for subsequent infusions. The infusion schedule is eight consecutive weekly infusions, followed 45 weeks later by four consecutive monthly infusions ( that is, every 4 weeks ).
Patients receiving Ofatumumab should be pre-medicated with corticosteroids, analgesics and antihistamines 30 minutes to 2 hours before the infusion.
Ofatumumab is not licensed for use in children under 18 years of age.
The summary of product characteristics ( SPC ) lists the following adverse effects as being most commonly associated with Ofatumumab: infections ( especially respiratory tract infections ), infusion-related reactions, neutropenia, rash and anaemia. Infusion-related reactions occur most commonly with the first infusion and less frequently with subsequent infusions.
Serious adverse events include high-grade ( grade 3 or above ) neutropenia and high-grade infections. ( Xagena )
Source: NICE, 2010