Clinical experience with Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin.

OBJECTIVE

The safety and efficacy of Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin, were evaluated in 54 patients who received 301 infusions of Octagam for a total amount of 9301 grams, during 24 months.

METHODS

Adverse reactions during and after Octagam infusion were carefully recorded. Serum IgG and ALT levels were recorded monthly. Antibodies to HIV, HBV and HCV were recorded every 3 months.

RESULTS

In 22 chronic lymphocytic leukemia patients and 4 multiple myeloma patients, the monthly infusion of 0.4 gr/ kg Octagam proved safe and effective in increasing IgG levels and potentially reducing the rate of serious bacterial infections. In 20 patients with ITP, infusion of 2 gr/kg of Octagam was safe and effective in increasing the platelet count and in arresting spontaneous bleeding or preventing bleeding prior to surgical procedures. In 8 patients with the antiphospholipid syndrome monthly infusions of Octagam were found to be safe. Adverse reactions following Octagam infusion were uncommon, generally mild and all were transient. Viral safety assays for HIV, HBV and HCV were all negative.

CONCLUSION

Octagam is a safe intravenous gammaglobulin effective in patients with secondary hypogammaglobulinemia and ITP.