Objectives RRMS is an immune-mediated, demyelinating condition often treated with the monoclonal antibody natalizumab. The administration of this intravenous infusion 4 weekly and the potential for adverse events poses a great inconvenience to patients requiring them to attend hospital day-units to receive treatment. We aimed to establish a safe, patient centric home infusion service for patients being treated with natalizumab as monotherapy for RRMS. Establishment of the home infusion service addressed regulatory requirements, risk minimisation strategies for known toxicities, occupational health and safety concerns and medication management, including storage and transport.
Methods An accredited, hospital substitute service (chemo@home) developed a protocol for the administration of natalizumab at home. The protocol was approved by the health services Expert Reference Group (Neurology) and Medication Advisory Group. Medical governance is retained by the neurologist. All health professionals (medical, nursing and pharmacy) complete the relevant sections of the Tysabri Australian prescribing program (TAPP). JC virus seronegative patients are monitored 6 monthly for seroconversion. Resources for the management of adverse reactions (including resuscitation equipment/medications) are available. All pre-infusion regulatory and clinical requirements are fulfilled. Natalizumab infusions are prepared, using a closed system, and administered in the patient’s home by registered nurses. Patient questionnaires on the experience were collected.
Results Between February 2014 and January 2017, 34 patients received 494 doses of natalizumab at home. A median of 11 (range 1–37). infusions were given. There were no episodes of anaphylaxis, hypersensitivity, unexpected toxicities and no additional safety concerns identified. Patient satisfaction was high. The at-home service made treatment significantly easier and less stressful than in hospital.
Conclusions To our knowledge this is the first establishment of an accredited, hospital-substitute service (chemo@home) in Australia which gives RRMS patients access to natalizumab treatment at home. It was achieved without compromising safety and with a high level of patient satisfaction.