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Examining Maintenance Treatment Options in CIDP

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What treatment options are available to help patients find relief from CIDP? Find out here.

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Important Safety Information

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  • Overview

    Although the complete mechanism of action of Ig therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) isn't fully understood, a broad spectrum of immunomodulatory effects is thought to be involved, including the neutralization and opsonization of autoantibodies.1,2,3 So what are the different types of Ig therapies that are available? To learn more, tune in with Dr. Charles Turck as he speaks with Dr. Karissa Gable, Associate Professor of Neurology at Duke University School of Medicine.

    References:

    1. Hizentra® [Prescribing Information]. CSL Behring. April 2023.
    2. Lehmann HC, Hartung HP. Plasma exchange and intravenous immunoglobulins: mechanism of action in immune-mediated neuropathies. J Neuroimmunol. 2011;231(1-2):61-69. doi:10.1016/j.jneuroim.2010.09.015
    3. Bayry J, Ahmed E, Toscano-Rivero D, Vonniessen N, Genest G, Cohen C, Dembele M, Kaveri SV, Mazer BD, Intravenous Immunoglobulin: Mechanism of Action in Autoimmune and Inflammatory Conditions, The Journal of Allergy and Clinical Immunology: In Practice (2023), doi: https://doi.org/10.1016/j.jaip.2023.04.002.
  • INDICATIONS

    Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:

    • Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.
    • Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.
      • Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.

    For subcutaneous infusion only.

  • IMPORTANT SAFETY INFORMATION

    WARNING: Thrombosis may occur with immune globulin products, including Hizentra. 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.

    For patients at risk of thrombosis, administer Hizentra 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.

    Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.

    IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.

    Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).

    Hizentra is derived from human blood. 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.

    The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.

    The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results.

    Please see full Prescribing Information for Hizentra including boxed warning.

    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.

    © 2024 CSL Behring
    USA-HCI-0073-FEB24

Schedule28 May 2024