Using Privigen in Special Populations
Use in Pregnancy and Lactation
Privigen is classified as Pregnancy Category C. Animal reproduction studies have not been conducted
with Privigen. It is not known whether Privigen can cause fetal harm when administered
to a pregnant woman or affect reproduction capacity. Privigen should be given to
pregnant women only if clearly needed. Immunoglobulins cross the placenta from maternal
circulation increasingly after 30 weeks of gestation.10
Privigen has not been evaluated in nursing mothers.
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Pediatric Use
Privigen was evaluated in 19 children and 12 adolescents with primary immunodeficiency
disease (PIDD). There were no apparent differences in the safety and efficacy profiles
as compared to adult subjects. No pediatric-specific dose requirements were necessary
to achieve the desired serum immunoglobulin G (IgG) levels. The safety and efficacy
of Privigen have not been established in pediatric patients with PIDD who are younger
than three years. The safety and efficacy of Privigen has not been established in
pediatric patients with immune thrombocytopenic purpura (ITP) under the age of 15.5
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Geriatric Use
Privigen should be used with caution in patients over 65 years of age who are judged
to be at increased risk of developing renal insufficiency (see Boxed Warning). Recommended
doses should not be exceeded, and the infusion rate selected should be the minimum
practicable. Privigen should be infused at a rate less than 8 mg/kg/min (0.08 mL/kg/min).
Discontinue Privigen if renal function deteriorates. Clinical studies of Privigen
did not include sufficient numbers of subjects age 65 and older to determine whether
seniors respond differently than younger people.
Privigen is derived from human plasma. The risk of transmission of infectious agents,
including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent,
cannot be completely eliminated.
Please see the Important Safety Information and
full Prescribing Information.
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Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen® is indicated for the treatment of patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen is also indicated to rapidly raise platelet counts to prevent bleeding in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Thrombotic events have been reported with Privigen and other IVIg treatments. Monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Aseptic meningitis syndrome (AMS) may occur infrequently with Privigen and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. There have been reports of noncardiogenic pulmonary edema in patients administered IVIg. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.
Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/hyperthermia, fatigue, and chills. Anemia was an additional common adverse reaction in patients being treated with Privigen for chronic ITP. The most serious adverse reactions in chronic ITP patients were aseptic meningitis syndrome in one subject and hemolysis in eight subjects.
For more information about Privigen, please see full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.