Microscopic view of primary immunodeficiency disease

Privigen® PID

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Product Information

Primary Humoral Immunodeficiency

Privigen is indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Chronic Immune Thrombocytopenic Purpura

Privigen is indicated for the treatment of patients age 15 years and older with chronic immune thrombocytopenic purpura (ITP) to raise platelet counts.

WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

See full prescribing information for complete boxed warning.

History of anaphylactic or severe systemic reaction to human immune globulin
Hyperprolinemia (PRIVIGEN contains the stabilizer L-proline)
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity

Intravenous Use Only

Indication	Dose	Initial Infusion Rate	Maintenance Infusion Rate (as tolerated)
PI	200 to 800 mg/kg (2 to 8 mL/kg) every 3 to 4 weeks	0.5 mg/kg/min (0.005 mL/kg/min)	Increase to 8 mg/kg/min (0.08 mL/kg/min)
ITP	1 g/kg (10 mL/kg) for 2 consecutive days	0.5 mg/kg/min (0.005 mL/kg/min)	Increase to 4 mg/kg/min (0.04 mL/kg/min)

PRIVIGEN is for intravenous administration only.

Monitor the patient’s vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombosis, administer PRIVIGEN at the minimum dose and infusion rate practicable, and discontinue PRIVIGEN administration if renal function deteriorates.
The following patients may be at risk of developing systemic reactions (mimicking symptoms of an inflammatory response or infection) on rapid infusion of PRIVIGEN (greater than 4 mg/kg/min [0.04 mL/kg/min]): 1) those who have never received PRIVIGEN or another IgG product or who have not received it within the past 8 weeks, and 2) those who are switching from another IgG product. 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 increase as tolerated.