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Privigen

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Privigen

Mechanism of Action

Treatment of Primary Immunodeficiency

Privigen™ contains a broad spectrum of antibody specificities. Appropriate doses of Privigen™ should restore abnormally low IgG levels to the normal range.

Treatment of Chronic Immune Thrombocytopenic Purpura

The mechanism of action of immunoglobulins in the treatment of chronic ITP is not fully understood. One possible mechanism may be the inhibition of the elimination of autoantibody-reacted platelets from the blood circulation by IgG-induced Fc-receptor blockade of phagocytes.17 Another proposed mechanism is the down-regulation of platelet autoantibody-producing B cells by anti-idiotypic antibodies in IGIV.18

Pharmacokinetics

Treatment of Primary Immunodeficiency

In the clinical study assessing the efficacy and safety of Privigen™ in 80 subjects with PI (see CLINICAL STUDIES), serum concentrations of total IgG and IgG subclasses were measured in 25 subjects (ages 13 to 69) following the 7th infusion for the 3 subjects on the 3-week dosing interval and following the 5th infusion for the 22 subjects on the 4-week dosing interval. After the infusion, blood samples were taken until Day 21 and Day 28 for the 3-week and 4-week dosing intervals, respectively.

Table 4 summarizes the pharmacokinetic parameters of Privigen™, measured as serum concentrations of total IgG.

Table 4: Pharmacokinetic Parameters of Privigen™ in Subjects with PI

Parameter 3-Week Dosing Interval
(n=3)		 4-Week Dosing Interval
(n=22)
Mean
(SD)		 Median
(Range)		 Mean
(SD)		 Median
(Range)
Cmax (peak, mg/dL) 2,550 2,340 2,260 2,340
(400) (2,290-3,010) (530) (1,040-3,460)
Cmin (trough, mg/dL) 1,230 1,200 1,000 1,000
(230) (1,020-1,470) (200) (580-1,360)
t½ (days) 27.6 27.8 45.4 37.3
(5.9) (21.6-33.4) (18.5) (20.6-96.6)
AUC0-t (day × mg/dL)* 32,820 29,860 36,390 36,670
(6,260) (28,580-40,010) (5,950) (19,680-44,340)
Clearance (mL/day/kg)* 1.3 1.3 1.3 1.3
(0.1) (1.1-1.4) (0.3) (0.9-2.1)
Cmax, maximum serum concentration; Cmin, trough (minimum level) serum concentration; t½, elimination half-life; AUC0-t, area under the curve from 0 hour to last sampling time.
* Calculated by log-linear trapezoidal rule.

Brand Name: Privigen
Generic Name: Immune Globulin Intravenous
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