Safety and tolerability
The safety and tolerability profile of octagam®10% in the ProDERM study was consistent with previously reported safety outcomes for IVIg administration.4,5,7
During the study, 10 patients (21%) in the octagamR10% treatment arm received premedication 5,7
In this study, use of premedication was only allowed if a patient had 2 consecutive infusion related adverse events 4,7
During the study, no patient met the criteria for haemolytic transfusion reaction (HTR)5,7
Related serious adverse reactions: muscle spasms and dyspnoea in one subject, loss of consciousness in one subject, deep vein thrombosis and pulmonary embolism in one subject, cerebrovascular accident, cerebral infarction, hypoesthesia and pulmonary embolism in one subject each.5
Octagam®10% in DM (ProDERM) study summary5,7
1. Goyal, N. A. (2019) Immune-Mediated Myopathies. Continuum 25, 1564–1585.
2. D’Silva, K. M. et al. (2021) Persistent premature mortality gap in dermatomyositis and polymyositis: A United Kingdom general population-based cohort study. Rheumatology 60, 2653–26602.
3. Glaubitz S. et al. (2020). Therapeutic advances in musculoskeletal disease 12, 1759720X19886494.
4. Octagam®10%. Summary of Product Characteristics. May 2021.
5. USA Product Information /Package Insert- OCTAGAM 10% (fda.gov) Octapharma USA Inc. June 2021.
6. Aggarwal, R. et al. 2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis. An International Myositis Assessment and Clinical Studies Group/ Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann. Rheum. Dis. 76, 792–801
7. Aggarwal, R. et al. Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam®10% in patients with dermatomyositis (“ProDERM Study”). Medicine (Baltimore) 100, e23677
8. Ahmed S, Chen KL, Werth VP. The validity and utility of the Cutaneous Disease Area and Severity Index (CDASI) as a clinical outcome instrument in dermatomyositis: a comprehensive review. Semin Arthritis Rheum. 2020;50(3):458-462.
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.