About HIZENTRA

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About CIDP and PI

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, progressive, and disabling autoimmune disease of the peripheral nervous system, with an estimated prevalence of 1.0 to 8.9 per 100,000 individuals.1,2 The disease attacks and destroys myelin, a material that protects the axons that transmit electrical signals throughout the body.3,4 This causes signaling impairment, leading to a loss of strength and sensation in the arms and legs.1-3

It has been shown that by simply diagnosing and treating primary immunodeficiency (PI), healthcare utilization costs can be reduced, saving an average of over $50,000 annually.5 Shifting the site of care from a hospital setting to a home-based setting can also reduce healthcare costs.6,7

The question then becomes which therapies are clinically sound and convenient enough for administration in a home-based setting. When choosing intravenous immunoglobulin (IVIg) vs subcutaneous immunoglobulin (SCIg) for home administration, considerations should also include systemic side effects the patient has experienced, infusion schedule, and venous access issues.8

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

Hizentra, an immune globulin subcutaneous (human) therapy, is the SCIg with the longest record of proven safety and efficacy in patients with Pl. It is the only SCIg with proven experience since 2010 and over 11.3 million exposures worldwide.9*

Beyond its clinical legacy, Hizentra is simple, convenient, and ready to use, with a range of vial sizes (5 mL, 10 mL, 20 mL, and 50 mL) and single-dose, prefilled syringe sizes (5 mL, 10 mL, and 20 mL).

CSL Behring is the only Ig portfolio offering an SCIg product for CIDP.

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*Estimate based on Hizentra grams sold worldwide from 2010 through October 31, 2021.

What is Hizentra?

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

  • Treatment of PI in adults and pediatric patients aged ≥2 years
  • Maintenance therapy in adults with CIDP to prevent relapse of neuromuscular disability and impairment
    – Limitation of Use: Hizentra maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Maintenance therapy beyond these periods should be individualized based upon the patient’s response and need for continued therapy

For subcutaneous infusion only.

Please see full prescribing information for Hizentra including boxed warning.
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What are the key benefits?

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#1 prescribed

Hizentra is the #1 prescribed SCIg for PI and the only SCIg approved for CIDP.9†
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Market share

Hizentra has a greater than 50% market share in SCIg.9†
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Comparable WAC

The wholesale acquisition cost (WAC) of Hizentra is comparable to that of other SClg products.10

†As of October 31, 2021, based on Adivo Associates sales data (used by permission).

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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 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.

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.

Please see full prescribing information for Hizentra including boxed warning.

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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. Dalakas MC, Medscape. Advances in the diagnosis, pathogenesis and treatment of CIDP. Nat Rev Neurol. 2011;7(9):507-517. doi:10.1038/nrneurol.2011.121 2. Mathey EK, Park SB, Hughes RA, et al. Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. J Neurol Neurosurg Psychiatry. 2015;86(9):973-985. doi:10.1136/jnnp-2014-309697 3. CIDP. GBS/CIDP Foundation International. Accessed July 21, 2022. https://www.gbs-cidp.org/cidp/ 4. Myelin. MedlinePlus. Accessed June 13, 2022. https://medlineplus.gov/ency/article/002261.htm 5. 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 6. Le Masson G, Solé G, Desnuelle C, et al. Home versus hospital immunoglobulin treatment for autoimmune neuropathies: A cost minimization analysis. Brain Behav. 2018;8(2):e00923. doi:10.1002/brb3.923 7. Vaughan LJ. Managing cost of care and healthcare utilization in patients using immunoglobulin agents. Am J Manag Care. 2019;25(6)(suppl):S105-S111. 8. Epland K, Perez EE; for the Immune Deficiency Foundation. IDF Guide to Ig Therapy: Immunoglobulin Replacement Therapy for People Living with Primary Immunodeficiency Diseases. Accessed June 30, 2022. https://primaryimmune.org/sites/default/files/publications/IDF Guide to Ig Therapy.pdf 9. Data on file. Available from CSL Behring as DOF HIZ-005. 10. IBM Micromedex RED BOOK. https://www.ibm.com/products/micromedex-red-book

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

Hizentra® 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.

HIZ-0475-OCT22

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