Privigen®, Immune Globulin Intravenous (Human), 10% Liquid by CSL Behring, LLC.



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Indications & Usage

Privigen is an Immune Globulin Intravenous (Human), 10% Liquid indicated for the treatment of:

  • Primary humoral immunodeficiency (PI)
  • Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

Limitations of Use:

Privigen maintenance therapy in CIDP has not been studied beyond 6 months.

 

Please see full prescribing information, including boxed warning.

Dosage & Administration

DOSAGE AND ADMINISTRATION

 

Indication

Dose

Initial Infusion Rate

Maintenance Infusion Rate
(as tolerated)

PI

200–800 mg/kg (2–8 mL/kg) every 3–4 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)

CIDP

Loading dose: 2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days Maintenance dose: 1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks

0.5 mg/kg/min (0.005 mL/kg/min)

Increase to 8 mg/kg/min (0.08 mL/kg/min)

    • Ensure that patients with preexisting renal insufficiency are not volume depleted, and discontinue Privigen if renal function deteriorates.
    • For patients at risk of renal dysfunction or thrombosis, administer Privigen at the dose and minimum infusion rate practicable.

     

    Please see full prescribing information, including boxed warning.

    Warnings & Precautions

    WARNINGS AND PRECAUTIONS

     

    • IgA-deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions.
    • Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
    • Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
    • Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion.
    • Hemolysis that is either intravascular or due to enhanced red blood cell sequestration may occur. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia
    • Elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed during/shortly following Privigen infusion. These blood pressure elevations were resolved or significantly improved within hours with either observation alone or changes in oral anti-hypertensive therapy. Check patients for a history of hypertension and monitor blood pressure during and following Privigen infusion.
    • Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
    • Carefully consider the relative risks and benefits before prescribing the high dose regimen (for chronic ITP and CIDP) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload.
    • Privigen is made from human blood and may contain infectious agents, e.g., viruses, the variant Creutzfeldt Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

     

    Please see full prescribing information, including boxed warning.

    Privigen is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
    Privigen® is a registered trademark of CSL Behring AG.
    Biotherapies for Life® is a registered trademark of CSL Behring LLC.
    Privigen ConnectSM is a service mark of CSL Behring LLC.

    ©2022 CSL Behring LLC. The product information presented on this site is intended for US residents only. PVG-0261-MAY22

     

    Please see full prescribing information for Privigen.

    Indications and Important Safety Information


    IMPORTANT SAFETY INFORMATION

    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.

    Privigen®, Immune Globulin Intravenous (Human), 10% Liquid, is indicated for the treatment of:

    • Primary humoral immunodeficiency (PI)
    • Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
    • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
      • Limitation of use: maintenance therapy in CIDP has not been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response.

    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 a history of hypersensitivity. 

    In patients at risk of developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine.

    Hyperproteinemia, increased serum viscosity, or hyponatremia can occur with Privigen. Infrequently, aseptic meningitis syndrome (AMS) may occur—especially with high doses or rapid infusion.

    Hemolysis, either intravascular or due to enhanced red blood cell sequestration, may occur. Risk factors include non-O blood group and high doses. Closely monitor patients for hemolysis and hemolytic anemia. 

    During and shortly following Privigen infusion, elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed. These elevations resolved or significantly improved within hours with oral anti-hypertensive therapy or observation alone. Check patients for a history of hypertension and monitor blood pressure during this period.

    Consider relative risks and benefits before prescribing high-dose regimen for chronic ITP and CIDP in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

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

    In clinical studies of patients with PI, the most common adverse reactions to Privigen, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, failure, and migraine. urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature. 

    In clinical studies of patients being treated for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. A serious adverse reaction was aseptic meningitis syndrome.

    In clinical studies of patients being treated for CIDP, the most common adverse reactions observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, flu-like illness, leukopenia, and rash.  Serious adverse reactions were hemolysis, exacerbation of CIDP, acute rash, increased diastolic blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine.

    Treatment with Privigen might interfere with a patient’s response to live virus vaccines and could lead to misinterpretation of serologic testing In patients over 65, do not exceed recommended dose and infuse at the minimum rate practicable.

    Please see full prescribing information for Privigen.