Immune Globulin Subcutaneous (Human), Vivaglobin^Ã? supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents.

Vivaglobin^Ã? is to be administered by injection into the subcutaneous tissue. Subcutaneous administration of immune globulin decreases bioavailability compared to intravenous administration.¹ The bioavailability of Vivaglobin^Ã? is approximately 73% compared to IGIV. Various factors, such as the site of administration and IgG catabolism, can affect absorption.^1,2 With Vivaglobin^Ã? administration, peak serum IgG levels are lower than those achieved with immune globulin intravenous (IGIV). Subcutaneous administration results in relatively stable steady-state serum IgG levels when administered on a weekly basis.^2,3 This serum IgG profile is representative of that seen in a normal population.

The pharmacokinetics (PK) of Vivaglobin^Ã? was evaluated in the PK phase of a pivotal 12-month clinical study conducted in the United States and Canada in subjects with primary immune deficiency (PID) (see CLINICAL STUDIES). Subjects who were previously treated with IGIV were switched over to weekly Vivaglobin^Ã? subcutaneous treatment and, after a 3-month wash-in/wash-out period, doses were individually adjusted to provide an IgG systemic exposure (area under the curve; AUC) that was not inferior to the AUC of the previous weekly-equivalent IGIV dose. For the 19 per-protocol subjects completing the wash-in/wash-out period, the average Vivaglobin^Ã? dose adjustment was 137% (range: 103 to 192%) of the previous weekly-equivalent IGIV dose. Following 10 to 12 weeks of treatment with Vivaglobin^Ã? at this adjusted dose, the final steady-state AUC determinations were made. The geometric mean ratio of the steady-state AUCs, standardized to a weekly treatment period, for Vivaglobin^Ã? versus IGIV treatment was 94.5% (range: 71.4 to 110.1%) with a lower 95% confidence limit of 89.8% for the per-protocol population (n = 17). Table 2 summarizes additional pharmacokinetic parameters for this study including dosing and serum IgG peak and trough levels following treatment with IGIV and Vivaglobin^Ã?.

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