Preventing infection in SID
Octagam® can help to prevent infection in patients who are immune compromised following secondary causes.3,4
Such secondary immunodeficiency (SID) can be associated with:11
Haematological malignancy (e.g., CLL or MM)
Drug treatment (e.g., anti-CD20 monoclonal antibodies, immunosuppressants or chemotherapeutics)
Medical treatment, such as haematopoietic stem cell transplant
Disease distribution of patients enrolled in observational studies of octagam® in SID (n=1,367).12
Preventing infections in SID
As shown below across a variety of immunodeficiencies, most patients (78.5–84.5%) had a favourable outcome with octagam® regarding infection frequency, severity and duration, as well as antibiotic use.* 1,12
The favourable effect on reducing the severity and the number of infections was also demonstrated in an open-label phase III study with 22 CLL patients. For 21 CLL patients data on infections prior and post octagam® treatment were available.14
*This was a post-authorisation analysis of observational, multicentre, open-label trials studying 2,397 immune compromised patient, of which 1,367 had SID.1,13 Patients with SID received on average 0.3 g/kg body weight per infusion of either octagam®10%.1 The median dose interval was 4.1 weeks.1
A 10-year observational study has demonstrated that octagam® is well tolerated in routine clinical use.2
Frequency of adverse drug reactions (ADRs) in a 10-year study2
In observational studies including patients with hematological malignancies the tolerability of octagam® was very well demonstrated.1,12
In a long-term non-interventional study of octagam®10%, the majority of ADRs for patients with SID were non-serious (92.4%), and of mild or moderate intensity (89%).*14 ADRs occurred for 1.5% of infusions, the most frequent being chills.14
*Study was multicentre and non-interventional and was performed between September 2008 and December 2013.14
1. 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.
2. 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.
3. Octagam®5%. Summary of Product Characteristics. May 2021.
4. Octagam®10%. Summary of Product Characteristics. May 2021.
5. 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.
6. 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.
11. Compagno N et al. Immunoglobulin replacement therapy in secondary hypogammaglobulinemia. Front Immunol. 2014; 5: 626.
12. Svorc D et al. Tolerability and efficacy of the intravenous immunoglobulins octagam®5% and 10% in secondary immunodeficiencies - A subgroup analysis of three non-interventional studies in Europe. Poster presented at ESID, September 11-17 2017, Edinburgh.
13. Brenner B. Clinical experience with octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin. Clin Exp Rheumatol. 1996; 14(Suppl. 15): S115-119.
14. Debes A et al. Tolerability and efficacy of the intravenous immunoglobulin octagam®10% in primary and secondary immunodeficiences - a subgroup analysis of a non-interventional study in Germany. Poster presented at ESID, September 21-24 2016, Barcelona.
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IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
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