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The proven leader in the SCIg market1

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to explore the value of our leading subcutaneous
immunoglobulin (SCIg) therapy.

Meet with your CSL Behring Associate Director of Corporate Accounts to explore the value of our leading subcutaneous immunoglobulin (SCIg) therapy.

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Explore the value of Hizentra

Learn more about CSL Behring’s immunoglobulin (Ig) products for the treatment of PI and CIDP.

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What is Hizentra?

Hizentra 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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What are the key benefits?

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#1 PRESCRIBED

#1 prescribed Ig for PI and the only 20% SCIg approved for CIDP2

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MARKET SHARE

Hizentra is the market share leader in new starts and switches* and holds more than ~58% of the SCIg market share1†

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PROVEN EXPERIENCE

Proven experience since 2010 and more than 14.9 million exposures worldwide1‡

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COMPARABLE WAC

The wholesale acquisition cost (WAC) of Hizentra is comparable to that of other SCIg products3

*Market share data January 2020 through December 2023.

†Based on volume share of SCIg brands through December 2023.

‡Estimate based on Hizentra grams sold worldwide, across all indications, from 2010 through March 2024.

Overview of disease states

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About CIDP

CIDP is a rare, progressive, and disabling autoimmune disease of the peripheral nervous system, with an estimated prevalence of 1 to 9 per 100,000 individuals.4-6 The disease attacks and destroys myelin, a material that protects the axons that transmit electrical signals throughout the body.7,8 This causes signaling impairment, leading to a loss of strength and sensation in the arms and legs.4,5,7,8

CIDP affects the peripheral nervous system—

all nerves that connect the spinal cord and brain with other tissues and organs in the body.9

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About PI

PI includes numerous rare, chronic disorders that increase the risk of persistent infections. There are more then 485 different forms of primary immune deficiency diseases affecting approximately 500,000 people in the United States.10, 11

PI is caused by a variety of genetic defects in which part of the body’s immune system is missing or impaired.12 Untreated patients are at increased risk of severe, persistent, and recurrent infection,12,13 which may occur at various locations throughout the body.

It has been shown that by simply diagnosing and treating PI, healthcare utilization costs can be reduced, saving an average of more than $50,000 annually.14

Some patients may benefit from a site-of-care shift

Shifting the site of care from a hospital setting to a home-based setting can also reduce healthcare costs.15

IV Bag

Intravenous immunoglobulin (IVIg) home infusion may significantly reduce site-of-care–related administration costs and improve adherence.16-18

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SCIg may be a valuable alternative for patients who19:

  • Have venous access issues
  • Experience IVIg-related adverse events
  • Want more flexibility or find IVIg inconvenient

The question then becomes which therapies are clinically sound and convenient enough for administration in a home-based setting. When choosing IVIg vs SCIg for home administration, considerations should also include systemic side effects the patient has experienced, infusion schedule, and venous access issues.20 CSL has developed Ig therapy options with an eye toward improving the patient experience and providing value and savings to the healthcare system.

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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.

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. Data on file. Available from CSL Behring as DOF HIZ-011. 2. Data on file. Available from CSL Behring as DOF HIZ-005. 3. Merative™ Micromedex® RED BOOK®. Accessed June 26, 2024.https://www.micromedexsolutions.com 4. 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 5. Mathey EK, Park SB, Hughes RAC, 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 6. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision. J Peripher Nerv Syst. 2022;27(1):94. doi:10.1111/jns.12479 7. Koski CL, Koehlinger K. CIDP: Chronic Inflammatory Demyelinating Polyneuropathy. GBS/CIDP Foundation International. May 2012. Accessed June 24, 2024. https://www.gbs-cidp.org/wp-content/uploads/2012/05/CIDP-Booklet.pdf 8. Myelin. MedlinePlus. Updated April 27, 2023. Accessed June 17, 2024. https://medlineplus.gov/ency/article/002261.htm 9. Amaral DG, Strick PL. The organization of the central nervous system. In: Kandel ER, Schwartz JH, Jessell TM, Siegelbaum SA, Hudspeth AJ, Mack S, eds. Principles of Neural Science, Fifth Edition. McGraw-Hill Education; 2014:337-355. Accessed June 25, 2024. https://neurology.mhmedical.com/content.aspx?bookid=1049§ionid=59138139 10. 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 11. Primary immune deficiency diseases (PIDDs). National Institute of Allergy and Infectious Disease. Accessed June 24, 2024. https://www.niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-pidds 12. What is PI? Immune Deficiency Foundation. Accessed June 24, 2024. https://primaryimmune.org/understanding-primary-immunodeficiency/what-is-pi 13. About primary immunodeficiency (PI). Centers for Disease Control and Prevention. May 15, 2024. Accessed June 24, 2024. https://www.cdc.gov/primaryimmunodeficiency/about/ 14. 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 15. Vaughan LJ. Managing cost of care and healthcare utilization in patients using immunoglobulin agents. Am J Manag Care. 2019;25(6)(suppl):S105-S111. 16. Data on file. Available from CSL Behring as DOF HIZ-009. 17. Slen B. Specialty Pharmacy Times. February 18, 2014. Accessed June 24, 2024. https://www.pharmacytimes.com/publications/specialty-pharmacy-times/2014/february-2014/Infused-Therapies-Cost-Savings-Benefits-Through-Home-Infusion 18. Luthra R, Quimbo R, Iyer R, Luo M. An analysis of intravenous immunoglobin site of care: home versus outpatient hospital. Am J Pharm Benefits. 2014;6(2):e41-e49 19. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1-S46. doi:10.1016/j.jaci.2016.09.023 20. Epland K, Perez EE; for the Immune Deficiency Foundation. IDF Guide to Ig Therapy: Immunoglobulin Replacement Therapy for People Living with Primary Immunodeficiency Diseases. July 11, 2018. Accessed June 24, 2024. https://primaryimmune.org/resources/print-material/idf-guide-ig-therapy

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.

©2024 CSL Behring LLC. The product information presented on this page is intended for US residents only.

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