Treatment of Primary Immunodeficiency

Privigen™ is indicated for the treatment of patients with primary immunodeficiency (PI) associated with defects in humoral immunity. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Treatment of Chronic Immune Thrombocytopenic Purpura

Privigen™ is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding.

Preparation and Handling

Privigen™ is a clear or slightly opalescent, colorless to pale yellow solution. Privigen™ should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Any solution that has been frozen must not be used. DO NOT SHAKE.

Do not mix Privigen™ with other IGIV products or other intravenous medications. If necessary, Privigen™ can be diluted with Dextrose Injection, USP (D5W). If large doses of Privigen™ are to be administered, several vials may be pooled using aseptic technique.

The Privigen™ vial is for single use only. Once the vial has been entered under aseptic conditions, its contents should be used promptly. Because the solution contains no preservative, Privigen™ should be infused as soon as possible. Any unused product or waste material should be disposed of in accordance with local requirements.

Treatment of Primary Immunodeficiency

The usual dose of Privigen™ for patients with PI is 200 to 800 mg/kg, administered every 3 to 4 weeks. An optimum target serum immunoglobulin G (IgG) trough level has not been established in randomized, controlled clinical studies. Doses should be adjusted to achieve the desired serum trough levels and clinical responses.

The recommended initial infusion rate is 0.5 mg/kg/min (0.005 mL/kg/min). If the infusion is well tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk of renal dysfunction or thrombotic events, Privigen™ should be administered at the minimum infusion rate practicable (see WARNINGS and PRECAUTIONS).

Treatment of Chronic Immune Thrombocytopenic Purpura

The usual dose of Privigen™ for patients with chronic ITP is 1 g/kg administered daily for 2 consecutive days, resulting in a total dosage of 2 g/kg.

The recommended initial infusion rate is 0.5 mg/kg/min (0.005 mL/kg/min). If the infusion is well tolerated, the rate may be gradually increased to a maximum of 4 mg/kg/min (0.04 mL/kg/min). For patients judged to be at risk of renal dysfunction or thrombotic events, Privigen™ should be administered at the minimum infusion rate practicable (see WARNINGS and PRECAUTIONS).

Administration

Privigen™ is for intravenous (IV) administration and should be given by a separate infusion line. An infusion pump may be used to control the rate of administration. The Privigen™ infusion line can be flushed with Dextrose Injection, USP (D5W) or 0.9% Sodium Chloride for Injection, USP.

The following patients may be at risk of developing inflammatory reactions on rapid infusion of Privigen™ (greater than 4 mg/kg/min [0.04 mL/kg/min]): 1) those who have not received Privigen™ or another IgG product; 2) those who are switching from another IgG product; and 3) those who have not received IgG in more than 8 weeks. These patients should be started at a slow rate of infusion (e.g., 0.5 mg/kg/min [0.005 mL/kg/min] or less) and gradually advanced to the maximum rate as tolerated.

Ensure that patients with pre-existing renal insufficiency and those predisposed to acute renal failure are not volume depleted before administering Privigen™ (SEE BOXED WARNING, WARNINGS and PRECAUTIONS).

The patient's vital signs should be observed and monitored carefully throughout the infusion. If side effects occur, the infusion should be slowed or stopped until the symptoms subside. The infusion may then be resumed at a lower rate that is comfortable for the patient.

Dosage Forms And Strengths

5 g in 50 mL solution

10 g in 100 mL solution

20 g in 200 mL solution

AND STORAGE AND HANDLING

Privigen™ is supplied in a single-use, tamper-evident vial containing the labeled amount of functionally active IgG. The components used in the packaging for Privigen™ are latex-free.

The following dosage forms are available:

Each vial has an integral suspension band and a label with two peel-off strips showing the product name, lot number, and expiration date.

When stored at room temperature (up to 25ºC [77ºF]), Privigen™ is stable for up to 24 months, as indicated by the expiration date printed on the outer carton and vial label. Do not freeze. Keep Privigen™ in its original carton to protect it from light.

Manufactured by: CSL Behring AG., Berne, Switzerland. US License No. 1766.
Distributed by: CSL Behring LLC., Kankakee, IL 60901 USA. FDA rev date: 7/26/2007

Bookmark this page: