ITP is an autoimmune disease characterised by a low platelet count, which leads to an increased risk of bleeding.1
octagam®5% can effectively increase platelet count, arrest spontaneous bleeding, and prevent bleeding prior to surgery in patients with chronic ITP*.2
Treatment response was observed in 82% of patients (18/22)*.3 For the remaining four patients, platelet count remained below 50 x 109/L, although arrest of bleeding was still observed.3
Response was usually rapid, appearing 24–48 hours after octagam® therapy and lasting 7–21 days.3
For seven patients, octagam® prevented excessive bleeding during splenectomy, and in another patient during laryngectomy. For all seven splenectomised patients, the platelet count remained above 200 x 109/L.3
The efficacy of octagam®10% for increasing platelet count in patients (n=115) with ITP has been proven in a phase III prospective trial.1
Most patients (80%; 92/115), with either newly diagnosed or chronic ITP, responded to treatment with octagam®10%*.1
Bleeding completely resolved in 75% (64/85) of patients with ITP who had bleeding at baseline.1
Multiple studies have shown the safety and tolerability of octagam® in ITP.1,2,4,5
In a 10-year prospective observational study, 3.5% of ITP patients experienced ADRs. The most common ADRs were non-serious, such as headache.4
Number of patients with ITP | 521 |
Number of infusions | 4,609 |
Percentage of patients with ADRs | 3.5% |
Percentage of infusions with ADRs | 0.43% |
In this study of 115 patients with ITP treated with octagam®10%, all ADRs were mild or moderate, and only one patient experienced a serious ADR*. No prophylactic medication was administered to prevent infusional ADRs.1
Number of patients, n (%) | |
|---|---|
Headache | 29 (25.0) |
Pyrexia | 17 (14.7) |
Heart rate increased | 13 (11.2) |
Hypertension | 5 (4.3) |
Heart rate decrease | 4 (3.4) |
Chills | 4 (3.4) |
Nausea | 4 (3.4) |
Vomiting | 4 (3.4) |
Blood pressure increased | 3 (2.6) |
Leukopenia | 3 (2.6) |
Haemolysis† | 0 |
†Haemolysis was reported in one patient but was judged as unrelated to the study drug by the investigator.
References
* Twenty-three infusions were given to arrest bleeding, and eight treatments were given to prevent surgical bleeding. In patients with bleeding, response was defined as arrest of bleeding, and an increase in platelet count to ≥50 x 109/L.19
** Clinical response was defined as an increase in platelet count to ≥50 x 109/L within 6 days of treatment (primary efficacy endpoint).6
Ochs HD et al. octagam®5%, an intravenous IgG product, is effcacious and well tolerated in subjects with primary immunodefciency diseases. J Clin Immunol. 2004; 24(3): 309-314.
Brenner B. Clinical experience with octagam®, a solvent detergent (SD) virus inactivated intravenous gammaglobulin. Clin Exp Rheumatol. 1996;14(Suppl. 15):S115–119.
Debes A, et al. Results of a multicentre, non-interventional study (NIS) on the long-term tolerability of octagam®5% in neurologic indications in Germany. Poster presented at the 2nd Congress of the European Academy of Neurology. May 28–31, 2016. Copenhagen, Denmark.
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.
Cherin P and Cabane J. Relevant criteria for selecting an intravenous immunoglobulin preparation for clinical use. Bio Drugs. 2010;24(4): 211–223.
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.
