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For CIDP For PI Request Info Medical Affairs Prescribing Information Important
Safety Information Visit Patient Site

 * Efficacy and Safety
   * Clinical Studies
   * Consistent Ig Levels
   * CIDP Guideline
 * Benefits of Hizentra
   * Patient Profiles
   * Flexibility and Convenience
 * Dosing and Administration
   * Dosing
   * Administration
 * Starting and Enrolling Patients
   * Prescribing Hizentra
   * Access and Billing Codes
   * Patient Resources
   * Hizentra Connect Support
 * Infusion Management and Training
   * Infusion Management
   * Infusion Specialist Nurse Support
   * SHARE Nurse Locator
   * SHARE Nurse Training Center
 * FAQs


Get Enrollment Forms

Elevating Patients’ Experience

Learn Why All Hizentra Patients Will Be Transitioned From Vials To Prefilled
Syringes Learn more

Get Enrollment Forms


FOR PEDIATRIC* AND ADULT PATIENTS WITH PRIMARY HUMORAL IMMUNODEFICIENCY


PROVEN. PERSONALIZED. LEADER.


PROVEN
EFFICACY & TOLERABILITY

Review study results


PERSONALIZED
WITH FLEXIBLE TREATMENT OPTIONS

Explore individualized therapy


LEADER
THE #1 IG PRESCRIBED FOR PI1

Start patients on Hizentra

*Ages 2 and older.

Hizentra is indicated for the treatment of primary immune deficiency (PI) in
adults and pediatric patients 2 years and older.

Insights from a CSL-sponsored Harris Poll survey†


OF 52 PI PATIENTS SURVEYED WHO HAVE USED BOTH IVIG AND SCIG, MOST PREFERRED
SCIG2



†In an online survey, 41 of 52 adults with PI who have used both IVIg and SCIg
preferred SCIg.


ENHANCING PATIENT EXPERIENCE AND IMPACTING LIVES

Hizentra offers greater flexibility to personalize treatment—addressing
lifestyle burdens and clinical challenges associated with IVIg—to fit the lives
of patients with PI.

See patient types Hizentra can help



ENHANCING PATIENT EXPERIENCE AND IMPACTING LIVES

Hizentra offers greater flexibility to personalize treatment—addressing
lifestyle burdens and clinical challenges associated with IVIg—to fit the lives
of patients with PI.

See patient types Hizentra can help


ELEVATE YOUR PATIENT’S EXPERIENCE

Prescribe proven protection with a first and only for Ig—
Hizentra Prefilled Syringes

Discover the convenience

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MEET ANNETTE,
A PATIENT WITH PI WHO ENJOYS THE CONVENIENCE OF HIZENTRA PREFILLED SYRINGES

See how prefilled syringes can help your patients


REQUEST MORE INFORMATION ABOUT HIZENTRA

Get info and materials


HAVE ADDITIONAL QUESTIONS?

Connect with CSL Behring Medical Affairs to find additional information and ask
questions.

Visit Medical Affairs
References: 1. Data on File. Available from CSL Behring as DOF HIZ-005. 2. Data
on File. Available from CSL Behring as DOF HIZ-013.

View information about Hizentra for:

PI

primary immunodeficiency


CIDP

chronic inflammatory demyelinating polyneuropathy



 * Hizentra Home
 * Efficacy and Safety
   * Clinical Studies
   * Consistent Ig Levels
   * CIDP Guideline
 * Benefits of Hizentra
   * Patient Profiles
   * Flexibility and Convenience
 * Dosing and
   Administration
   * Dosing
   * Administration
 * Starting and Enrolling
   Patients
   * Prescribing Hizentra
   * Access and Billing Codes
   * Patient Resources
   * Hizentra Connect Support
 * Infusion Management
   and Training
   * Infusion Management
   * Infusion Specialist Nurse Support
   * SHARE Nurse Locator
   * SHARE Nurse Training Center
 * FAQs
 * Medical Affairs
 * Request Info
 * Contact Us
 * About CSL Behring

Top of Page
Important Safety Information

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.


Contact Us | Privacy Policy | Cookie Policy | Terms of Use | Site Map | About
CSL Behring | Patent Information
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® is a registered trademark of CSL Behring AG.
Hizentra ConnectSM is a service mark of CSL Behring LLC.
Voice2Voice® is a registered trademark of CSL Behring GmbH.

©2024 CSL Behring LLC. The product information presented on this site is
intended for US residents only. USA-HIZ-0055-FEB24
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