Primary Immunodeficiency (PID)

Octagam® efficacy for PID        

In a multicentre, open-label clinical trial, octagam®5% helped to prevent serious infections for patients with PID. An incidence of only 0.1 serious infections per patient per year was observed*.6 This is well below the FDA requirement of ≤1 serious infection per patient per year for demonstrating prevention of infection.6

Secondary endpoints

Events per patient, mean (range)

Number of days absent from work or school

5 (0–22)

Number of days hospitalised

0.3 (0–6)

Number of physician or emergency room visits

2 (0–11)

Study details

Number of patients


Days in the study/patient, mean (range)

345 (170–393)

Number of infusions


Dosing of octagam®5% received

400–600 mg/kg every 28 days or 300–450 mg/kg every 21 days

*There were five serious infections in three patients: pneumonia (one), bacteraemia (two), and ‘bacteraemia or sepsis’ (two). 6  

The most common ADRs from this study are shown below. No serious adverse events were connected to treatment with octagam®5%*.7

Most common ADR

Number of patients, n (%)

Number of ADRs, n (%)


7 (15)

18 (25)


3 (6)

4 (6)


2 (4)

5 (7)

Back pain

2 (4)

2 (3)

Chest pain

2 (4)

2 (3)

Injection site reactions

2 (4)

2 (3)

Study 1 ¹¹

Study 2 ²*

Number of patients



Number of infusions



Percentage of patients with ADRs

Not specified


Percentage of infusions with ADRs



Prospective observational studies demonstrate the tolerability of octagam®5%.

*The PID cohort is a subgroup of patients analysed in this study.

†Not all patients received octagam®.11


 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.

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.

7. 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. Hematololgy. 2017; 1-6.

11. Bichuetti-Silva DC, et al. Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions. Int Immunopharmacol. 2014;23(2):442–446.

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).

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