Revised SPC: Cuvitru (Human normal immunoglobulin) 200 mg/ml solution for subcutaneous injection
SPC updated to include new indication for the treatment of secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4g/l.
Source:
electronic Medicines compendium
SPS commentary:
The new indication replaces more specific indications for use in the treatment of hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed or are contra-indicated, or in patients with multiple myeloma, and the treatment of hypogammaglobulinaemia in patients pre- and post-allogeneic haematopoietic stem cell transplantation.