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About PRIVIGEN

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CSL Behring innovates and collaborates to improve access and care for patients.

About CIDP and PI

Treating primary immunodeficiency (PI) can reduce healthcare utilization costs, and even more cost savings could be realized by shifting care to home-based intravenous immunoglobulin (IVIg) administration.1

Payers are challenged with identifying which home-based therapies are both clinically sound and convenient. Privigen is proven IVIg therapy for PI and chronic inflammatory demyelinating polyneuropathy (CIDP) and the only IVIg formulated with proline for immunoglobulin G stabilization.

CSL Behring has a broad portfolio of immunoglobulin (Ig) products.

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What is Privigen?

Privigen is an IVIg replacement therapy indicated for the treatment of PI, chronic immune thrombocytopenic purpura (ITP) in patients aged ≥15 years, and CIDP in adults.

Limitation of use: Privigen maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with Privigen in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient's response and demonstrated need for continued therapy.

Please see full prescribing information for Privigen.
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What are the key benefits?

CSL Behring has one of the world’s largest and most innovative plasma collection networks with 2 Ig products to meet patient needs: IVIg and subcutaneous immunoglobulin (SCIg).

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Rigorous donor screening process

and state-of-the-art manufacturing facilities help enhance the safety of Privigen
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Proven efficacy and tolerability

>1 million patient-years of therapy2

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

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 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, 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, influenza-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.

Indications

Privigen 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.

Please see full prescribing information for Privigen.

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To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Modell V, Orange JS, Quinn J, Modell F. Global report on primary immunodeficiencies: 2018 update from the Jeffrey Modell Centers Network on disease classification, regional trends, treatment modalities, and physician reported outcomes. Immunol Res. 2018;66(3):367-380. doi:10.1007/s12026-018-8996-5 2. Data on file. Available from CSL Behring as DOF PVG-006.

Privigen is manufactured by CSL Behring AG and distributed by CSL Behring LLC.

Privigen® is a registered trademark of CSL Behring AG.

Driven by Our Promise™ is a trademark of CSL Behring LLC.

©2022 CSL Behring LLC. The product information presented on this page is intended for US residents only.

PVG-0049-OCT22

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