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 as replacement therapy for 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 raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: Use of Immune Globulin Intravenous (IVIg) products, particularly those containing sucrose, have been associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. Privigen does not contain sucrose. Administer Privigen at minimum rate practicable in patients at risk of renal dysfunction or acute renal failure. At-risk patients include those with preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; over 65 years of age; or receiving known nephrotoxic drugs. See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Monitor patient vital signs throughout infusion of Privigen. In cases of severe hypersensitivity or anaphylactic reactions, discontinue administration and institute appropriate medical treatment. In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
Patients could experience increased serum viscosity, hyperproteinemia or hyponatremia; infrequently, aseptic meningitis syndrome (AMS) may occur (most often with high doses and/or rapid IVIg infusion). There have been reports of IVIg-related hemolysis, hemolytic anemia, and pulmonary adverse events, including transfusion-related acute lung injury (TRALI). Avoid high-dose regimen where fluid volume is of concern.
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 of patients being treated with Privigen for PI, the most serious adverse reaction was hypersensitivity (one subject). Adverse reactions observed in >5% of subjects with PI were headache, pain, nausea, fatigue, chills, vomiting, joint swelling/effusion, pyrexia, and urticaria.
In clinical studies of patients being treated with Privigen for chronic ITP, the most serious adverse reactions were AMS (one subject) and hemolysis (eight subjects). Adverse reactions seen in >5% of subjects with chronic ITP were headache, pyrexia/hyperthermia, positive DAT, anemia, vomiting, nausea, increases in conjugated and unconjugated bilirubin, hyperbilirubinemia, and increased blood lactate dehydrogenase.
Treatment with Privigen might interfere with a patient's response to live virus vaccines and could lead to misinterpretation of serologic testing.
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.