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September 12th, 2003
Pharmacovigilance study with Octagam®:
8 years results
An extensive post-marketing surveillance (PMS) programme is considered to be the most appropriate way to gather information on the safety and tolerability of a biological product. Compared to clinical trials, more patients are enrolled and a larger number of batches are studied over a longer period of time.
Such a large-scale PMS study was initiated for Octagam in Germany in 1995 and has been actively running ever since. This has allowed continuous assessment of both the safety and tolerability of Octagam under routine conditions.
Over the past eight years, data from more than 5,300 patients and 74,000 treatment episodes were gathered. Patients with any kind of disease that require treatment with Octagam have been included, whether treated in-hospital or on an out-patient basis.
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Medical conditions treated with Octagam include:
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primary immunodeficiencies (PID) including: agammaglobulinaemia, hypogammaglobulinaemia, CVID, SCID, Wiskott-Aldrich-syndrome and IgG subclass deficiencies
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secondary immunodeficiencies (SID) as a result of AIDS, leukaemia, myeloma, and bone marrow transplantation
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autoimmune diseases (AID) i.e. thrombocytopenia, Guillain-Barré-Syndrome, Kawasaki’s disease, CIDP, myasthenia gravis, lupus, and multiple sclerosis. |
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No viral transmissions have ever been observed. This proves the excellent safety record of Octagam and the efficacy of the two distinct viral inactivation steps utilised in its manufacture: solvent-detergent treatment and pH4 incubation.
Adverse drug reactions have occurred in less than 0.5 % of infusions, and in most cases have been judged as mild or moderate. Most frequently observed reactions are rigors, fever, headache, nausea and flushing (frequency 0.04 - 0.16 %).
The biggest group of patients with autoimmune disease followed in the study were those with Multiple Sclerosis (MS).
Octagam is often used as the treatment of choice in MS, for patients who develop adverse reactions (i.e. flu-like symptoms, anaemia, leukopenia, increased liver enzymes, skin reactions) or have contraindications to other MS therapies such as interferons or copaxone.
To date, treatment of 552 patients has been documented. Approximately, 75% of the MS patients included are female and 6 % received Octagam because they either wanted to become pregnant, were pregnant, or were breast-feeding.
In total the MS patient group received 8,804 single infusions with an average dose of 14.1 ± 7.4 g Octagam.
The mean dosage for MS was 211 ± 114 mg/kg bodyweight (BW)
Average infusion speed was 3.2 ± 1.2 ml/min.
Adverse events occurred in only 47 of 8,804 treatments (0.5 %), and all were of either mild or moderate intensity.
 Thus, the PMS has demonstrated that, the tolerability of Octagam in non-licensed indications is comparable to the labelled ones.
In both cases the incidence of adverse events observed with Octagam is much lower than that previously reported in the literature with other IVIG preparations.
Octagam is the first double virus inactivated, high purity intravenous immunoglobulin in a liquid, ready-to-use formulation that can be stored at room temperature for 2 years.
Octagam: Immunoglobulin with long-term study proven tolerability
© Octapharma AG, 2003
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