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New Model Provides Insights Into Intravenous and Subcutaneous Immunoglobulin Pharmacokinetics in Patients With Primary Immunodeficiencies
Date:3/19/2011

rivigen.com/">first proline-stabilized intravenous immunoglobulin. CSL Behring manufactures Hizentra at its state-of-the art facility in Bern, Switzerland, where advanced technologies are applied to further ensure product safety and ample supply. This facility represents the long-term commitment of CSL Behring to global Ig markets.

Important Safety InformationHizentra®, Immune Globulin Subcutaneous (Human), is indicated as replacement therapy for the treatment of patients with primary humoral immunodeficiency.

Hizentra is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations or components of Hizentra, and in persons with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. If anaphylactic reactions are suspected, administration should be discontinued immediately and the patient treated as medically appropriate. Because Hizentra contains the stabilizer L-proline, it is also contraindicated in patients with hyperprolinemia.

Hizentra should be administered subcutaneously only.

Hizentra is derived from human plasma. The risk of transmission of infectious agents including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be eliminated completely.

The most common drug-related adverse reactions, observed in 5 percent or more of subjects in the clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue.

Monitor patients for reactions associated with IVIg treatment that might occur with Hizentra, including renal dysfunction/failure, thrombotic events, aseptic meningitis syndrome (AMS), hemolysis and transfusion-related acute lung injury (TRALI).

For full prescribing information, visit www.hizentra.com/consumer/prescribing-information.aspx.

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SOURCE CSL Behring
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