- « Previous
- Clinical Pharmacology
- Next »
Privigen
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. |
||||
Generic Name: Immune Globulin Intravenous
- « Previous
- Clinical Pharmacology
- Next »
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
Health Extras
Herbal First Aid
Herbal medicine is ancient, but only in recent years have many people started to take notice of its all natural healing powers. See more WebMD Videos »
Privigen
Health Resources
Slideshows
Updated & New
RxList does not provide medical advice, diagnosis or treatment.