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May 14th, 2004

Gammanorm® receives approval in 9 more countries


Gammanorm, immunoglobulin for subcutaneous use has been available in Scandinavia (Sweden, Norway, Denmark and Iceland) for the subcutaneous treatment of patients with primary and secondary immunodeficiency for over 15 years.

Following a recent Mutual Recognition Procedure Gammanorm has received regulatory approval in 9 additional EU countries.

Immunoglobulin prophylaxis for immunodeficiency patients by rapid subcutaneous infusions administered using small portable pumps was introduced during the late 1980s. Several reports have shown that the subcutaneous method is feasible, safe, efficient, cost-effective and highly appreciated by the patients.

Gammanorm is a 16.5% IgG solution, virus inactivated by the Solvent Detergent procedure. The IgG subclass distribution is within normal range and the content of IgA is very low.

Gammanorm is indicated for :
  • Replacement therapy in adults and children in primary immunodeficiency syndromes
  • Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections

The long history and experience of Gammanorm use in Scandinavia should provide confidence to care-givers prescribing a lifelong treatment and for patients who would like to receive their treatment at home. Subcutaneous home treatment with Gammanorm contributes to increased patient comfort, reduces hospital visits, and significantly lowers costs.

©Octapharma AG, 2004

Further information on subcutaneous gammaglobulin
1. Gardulf A, Hammarström L, Smith C.I.E. Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet 1991;338:162-6.

2. Gardulf A, Möller G, Jonsson E. A comparison of the patient-born costs of therapy with gamma globulin given at the hospital or at home. Int J Techn Ass Health Care 1995;11:345-53.

3. Gardulf A, Andersen V, Björkander J, Ericson D, Frøland S. S, Gustafson R, Hammarström L, Jacobsen M.B, Jonsson E, Möller G, Nyström T, Søeberg B, Smith C. I. E. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: Safety and costs. Lancet 1995;345:365-9.

4. Hansen S, Gustafson R, Smith CIE, Gardulf A. Express subcutaneous IgG infusions: decreased time of delivery with maintained safety. Clin Immunol 2002;104:237-241.

5. Abrahamsen TG, Sandersen H, Bustnes A. Home therapy with subcutaneous immunoglobulin infusions in children with congenital immunodeficiencies. Pediatrics 1996; 98: 1127-31.