Secondary Immunodeficiency (SID)

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

Octagam® tolerability in SID

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

References

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.

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.