About octagam®

Octagam® is a liquid, ready to use intravenous immunoglobulin (IVIg) originally launched in 1995 as the first S/D treated (solvent/detergent) immunoglobulin from Octapharma. Today octagam® is available in two concentrations, produced using a reliable formulation and manufacturing process, resulting in a very well tolerated immunoglobulin therapy which is available in more than 80 countries worldwide.1-9

octagam®5%

Since 1995, octagam® has been helping to improve the lives of patients with immune disorders.1,2

A ready-to-use liquid IVIg with convenient room temperature storage.3

octagam®10%

The 10% formulation and well tolerated higher maximum infusion rate, can provide additional convenience for a wider range of indications.4,5

The same tried and trusted formulation.4

octagam® indications^3,4

Replacement therapy in adults, children and adolescents (0-18 years) in:

Primary immunodeficiency syndromes (PID) with impaired antibody production
Secondary immunodeficiencies (SID) 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.

*PSAF=failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypep-tide antigen vaccines

Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or not advised.

Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.

Immunomodulation in adults, and children and adolescents (0-18 years) in:

Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count
Guillain Barré syndrome
Kawasaki disease (in conjunction with acetylsalicylic acid)
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Multifocal motor neuropathy (MMN)

Immunomodulation in adults with:

Active dermatomyositis* treated with immunosuppressive drugs including corticosteroids, or with intolerance or contra-indications to those drugs

*Approved for octagam®10% only

Proven efficacy and safety of octagam® in diverse clinical studies

Octagam®, backed by extensive clinical research 1,2,5-9, offers a trusted solution for multiple indications while ensuring quality and safety through a rigorous manufacturing process.3,4

Manufacturing that delivers quality ensuring pathogen safety

Octagam® is manufactured to preserve the integrity of IgG and has a distribution of IgG subclasses like in a normal healthy population. Screening of donors and plasma, along with validated virus inactivation steps during the manufacturing process, ensures a high level of safety against pathogen transmission.3,4,10,11

The processes used in manufacturing octagam® have also been shown to inactivate the Zika virus.12

There has never been a documented case of virus transmission by any octagam® infusion.

From donor to patient

Our production process explained in a short video

References

Frenzel W, et al. Tolerability and safety of octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials. Int J Clin Pharmacol Ther. 2016;54(11):847-855.
Debes A, et al. Tolerability and safety of the intravenous immunoglobulin octagam®: a 10-year prospective observational study. Pharmacoepidemiol Drug Saf. 2007;16(9):1038-1047.
Octagam®5%. Summary of Product Characteristics. July 2024.
Octagam®10%. Summary of Product Characteristics. July 2024.
Robak et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam®10%) in patients with immune thrombocytopenia. Hematology. 2010; 15 (5): 351-359.
Ochs HD et al. octagam®5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol. 2004; 24(3): 309-314.
Wietek S et al. Tolerability and safety of the intravenous immunoglobulin octagam®10% in patients with immune thrombocytopenia: a post-authorisation safety analysis of two non-interventional phase IV trials. Hematology. 2017; 1-6.
Aggarwal R. et al. Trial of Intravenous Immune Globulin in Dermatomyositis. N Engl J Med. 2022; 6;387(14):1264-1278.
Aggarwal R. et al. Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study. Arthritis Res Ther. 2024; 17;26(1):27.
European Medicines Agency. Guideline on plasma-dervied medicinal products. EMA/CHMP/BWP/706271/2010. 2011.
European Medicines Agency. Plasma Master File, EMEA/H/PMF/000008/05/AU/002.
Kuhnel D, et al. Inactivation of Zika virus by solvent/detergent treatment of human plasma and other plasma-derived products and pasteurization of human serum albumin. Transfusion. 2017;57(3pt2):802-810.

This is an international website for octagam® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

If you wish to contact Octapharma please use the contact form on our corporate website www.octapharma.com.