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Providing essential Ig supplementation
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About PI and CIDP

Primary immunodeficiency (PI) diseases occur in patients who have an intrinsic defect in the immune system. The immune system may have impaired function in one or more components or a component may be absent altogether.1 There are 485 different PIs currently recognized by the International Union of Immunological Societies Expert Committee—some are common, others are quite rare.2 Untreated patients are at increased risk of severe, persistent, and recurrent infection, which may occur at various locations throughout the body.3

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disorder of the peripheral nerves characterized by progressive weakness and a loss of sensory and motor function in the legs and arms. CIDP is a neurological disorder with an underlying autoimmune basis: the immune system perceives the nerves’ protective myelin as foreign and attacks it. Damaged or removed myelin prevents effective communication in the nervous system, as electric impulses transmitted to and from the brain are disrupted or lost.4

Privigen is an important part of CSL Behring’s portfolio of immunoglobulin (Ig) products.
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What is Privigen?

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

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?

For PI

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PROVEN EFFICACY

The annual rate of serious bacterial infections (SBIs)* was 0.08 in the US phase 3 pivotal trial and 0.02 in the extension study5

For CIDP

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RAPID RESPONSE

Almost all who responded to Privigen did so after 1 to 2 maintenance treatments at Weeks 4 and 7. Overall response rates to Privigen were 61% and 73% in PRIMA and PATH, respectively

*SBIs were defined as pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

Overall response rate was defined as percentage of subjects who experienced at least a 1-point decrease in adjusted INCAT score.

In a prospective, open-label, single-arm, multicenter clinical study (PRIMA), 28 subjects with CIDP received a Privigen loading dose of 2 g/kg followed by Privigen maintenance doses of 1 g/kg every 3 weeks for up to 21 weeks with 3-week follow-up. In a second prospective, open-label Privigen prerandomization phase of a multicenter clinical study (PATH), 207 IVIg-pretreated subjects with CIDP received a Privigen loading dose of 2 g/kg followed by up to 4 Privigen maintenance doses of 1 g/kg every 3 weeks for up to 13 weeks.

INCAT=Inflammatory Neuropathy Cause and Treatment; PATH=Polyneuropathy and Treatment with Hizentra; PRIMA=Privigen Impact on Mobility and Autonomy.

The value of Privigen

CSL Behring is a class leader in IVIg treatments with a broad portfolio of Ig products

IVIg in US hospitals

A TOP 3 IVIg IN US HOSPITALS

Privigen has been consistently in the top 3 in US hospitals since 2010

§Based on volume share in the hospital segment as of Q4 2023.

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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. About primary immunodeficiency (PI). Centers for Disease Control and Prevention. May 15, 2024. Accessed October 3, 2024. https://www.cdc.gov/primary-immunodeficiency/about 2. Tangye SG, Al-Herz W, Bousfiha A, et al. Human inborn errors of immunity: 2022 update on the classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2022;42(7):1473-1507. doi:10.1007/s10875-022-01289-3 3. Manage your recurrent infections. Immune Deficiency Foundation. July 2, 2021. Accessed October 7, 2024. https://primaryimmune.org/resources/news-articles/manage-your-recurrentinfections 4. CIDP. GBS/CIDP Foundation International. Accessed October 2, 2024. https://www.gbs-cidp.org/cidp/ 5. Perez EE, Hébert J, Ellis AK, et al. Efficacy, safety and tolerability of a new 10% intravenous immunoglobulin for the treatment of primary immunodeficiencies. Front Immunol. 2021;12:707463. doi:10.3389/fimmu.2021.707463 6. Data on file. Available from CSL Behring as DOF PVG-002.

Privigen is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Privigen® is a registered trademark of CSL Behring AG.
©2025 CSL Behring LLC. The product information presented on this page is intended for US residents only.
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