Octagam

Octagam approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Octagam, Immune Globulin Intravenous (Human) 5%, a liquid, ready-to-use, solvent/detergent treated immunoglobulin intravenous (IGIV) product indicated for the treatment of primary immunodeficiency diseases (PID).

In replacement therapy for PID, Octagam provides a broad spectrum of IgG antibodies against bacterial and viral pathogens. It is not less than 96 percent pure IgG and provides high functionality because the integrity of the Fc portion of the IgG molecule is maintained. Furthermore, greater than 90 percent of the IgG molecules in Octagam are monomers and dimers, the only molecular forms of IgG thought to provide therapeutically meaningful activity. The Octagam preparation is physiologically similar to normal plasma in concentration, nativity, osmolality, and distribution of IgG subclasses. It contains no additional stabilizers and is sucrose, fructose, and preservative free.

Octagam is supplied as a ready-to-use liquid and requires no filtration prior to intravenous infusion. Available in 1.0g, 2.5g, 5g or 10g single use bottles, Octagam can be stored at room temperature for up to 18 months (or up to 24 months when refrigerated).

Octagam Exceeds New U.S. IGIV Efficacy Standard
The efficacy of Octagam was documented in an open-label, multicenter, U.S. study of 46 patients (including 11 patients less than 15 years) with primary immunodeficiencies who received a total of 694 infusions over a 12 month period. Conducted under the auspices of the IDF, the study utilized the observed rate of serious infections as the primary efficacy endpoint (the lower the rate, the greater the presumed protection provided by the IGIV product), a new evaluation criterion established by the FDA. In the study, Octagam therapy was associated with 0.1 serious infections per patient per year, which compared favorably with the efficacy standard of 1 serious infection per patient per year set by the FDA for approval of IGIV products.

The study, published in the May 2004 issue of the Journal of Clinical Immunology, also measured secondary efficacy endpoints involving patient productivity and healthcare utilization. The average number of work or school days missed, days spent in the hospital, and visits to a physician or emergency room, during the year-long study were very low (5.5 days, 0.4 days, and 2.1 visits, respectively).

Octagam Clinical Safety Profile Supported by European Experience
The majority of adverse reactions documented in the Octagam study were mild to moderate in severity and the product was generally well tolerated. The most commonly reported side effects included headache, nausea, chills, back or chest pain. In general, reported adverse reactions to Octagam in patients with either congenital or acquired immunodeficiencies are similar in kind and frequency to other IGIV products. Various minor reactions, such as headache, chills, backache, chest pain, fever, allergic reactions, arthralgia, dizziness, changes in blood pressure, cutaneous reactions and/or nausea and vomiting may occasionally occur and tend to be related to the rate of infusion.

Cases of reversible aseptic meningitis and migraine, isolated cases of reversible hemolytic anemia, and reversible increases in liver function tests have been observed with Octagam. Immediate anaphylactic and hypersensitivity reactions are a remote possibility. Epinephrine should be available for treatment of any acute anaphylactoid reaction.

Octagam carries a class warning about reports associating IGIV products with renal dysfunction, acute renal failure, osmotic nephrosis, and death, particularly in patients predisposed to acute renal failure. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number. Octagam does not contain sucrose.

Viral Safety of Octagam
Octagam is made from pooled human plasma of U.S. origin. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Octapharma was the first company to introduce the "gold standard" solvent detergent process in the routine production of plasma derivatives, including Octagam. The Octagam manufacturing process incorporates multiple production steps, including Cohn-Oncley fractionation, treatment with solvent/detergent (S/D) (TnBP+Triton X-100) and a 24-hour pH4 treatment, to provide very high levels of viral reduction and inactivation. In vitro studies conducted during the manufacture of Octagam demonstrate that combined these methods provide significant reduction of a wide array of transfusion relevant viral pathogens, including lipid-enveloped viruses such as HIV, hepatitis B and C, West Nile Virus (WNV), and the SARS virus. In nearly 10 years of clinical experience with more than 1,000,000 doses given of Octagam in Europe, no virus transmission has been reported.

Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

For further information, please visit www.octapharma.com
For Ordering information, please call 1-800-826-6905.

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