Introduction: Regulatory agency approval of a drug signifies
that the drug’s benefits outweigh the risks of administration.
Intravenous immunoglobulin (IVIg) has been approved for some
indications, but its use also extends to other off-label (non-approved)
indications. This study analyzes the use and cost associated with IVIg
treatment in a healthcare institution Methods: Descriptive,
observational, cross-sectional, drug-utilization study. The study
evaluates pattern, determinants of use, and costs of treatment with
IVIg, comparing approved and off-label indications. Results: 66
patients were included. The most frequent indications of use were
Guillain-Barré syndrome (50%) and immune thrombocytopenic purpura
(22.7%). Ten (10) patients received IVIg for off-label indications,
most frequently polymyositis/dermatomyositis (10.6%). A total of 156
individual prescriptions were registered, 45 of them off-label
indications. The INVIMA (Instituto Nacional de Vigilancia de
Medicamentos y Alimentos, in Colombia) off-label administrations had a
higher cost compared to approved ones ($16,713,213 vs $8,383,855,
p<0.001). Similar results were found when comparing costs with
FDA and EMA-approved indications ($13,881,994 vs 9,570,488, p: 0,015).
Conclusion: Approximately a third of IVIg administrations are
outside indications approved by regulatory agencies. Costs of off-label
IVIg indications were significantly higher than approved ones. Consensus
among agencies is required regarding IVIg, especially in off-label
indications.
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