Hizentra — The Ig Therapy That Fits Your Life

20% Subcutaneous Immunoglobulin (SCIg) Therapy for PIDD

Hizentra is a subcutaneous immunoglobulin (Ig) replacement therapy that you can infuse yourself (after training from your healthcare provider). It is infused just under your skin, using a small needle and infusion pump. It is approved by the FDA for the treatment of primary humoral immunodeficiency disease (PIDD, also known as PI) in adults and pediatric patients age 2 and older.

Because Hizentra can be stored at room temperature, it's always ready to use whether you're at home or on the go. Hizentra also offers several flexible dosing options, so you and your doctor can choose the infusion schedule that best fits your lifestyle and preference.

Steady-State

9,10,*,†

* No difference in the clinical benefit of SCIg and IVIg serum profiles has been demonstrated by substantial clinical evidence or experience.

†The weekly SCIG regimen is based on clinical studies; the biweekly and frequent regimens are based on pharmacokinetic modeling and simulations

Steady-State

Less peak and trough

  • Hizentra enables patients to maintain steady-state Ig levels with lower peaks and higher trough serum levels than monthly IVIg.
  • No matter which dosing schedule you choose, Hizentra is able to maintain a consistent level of protection against infection.5

*Based on an equivalent dose in grams

Low Volume

Infuse less volume with small needles

As a concentrated 20% Ig solution, Hizentra delivers the lowest volume on the market – half the volume of the 10% Ig solutions.*

Low volume with all dosing options

  • Weekly dosing: Hizentra allows patients currently on 10% SCIg to infuse half the volume at each infusion.*
  • Biweekly (every two weeks) dosing: Hizentra allows patients currently on 10% SCIg to infuse less frequently without an increase in volume.*
  • Frequent dosing: Hizentra allows patients to infuse at lower volumes than with 10% SCIg.*

Individualized Therapy

Dosing that fits your needs and lifestyle

In January 2015, the FDA approved flexible dosing options for Hizentra, allowing patients to dose as infrequently as biweekly (every two weeks) or as often as daily.

  • With the flexible dosing options of Hizentra, you can work with your prescriber to create an individualized treatment plan to fit your specific needs.
  • Hizentra offers you freedom and flexibility – you can infuse when and where it is most convenient because Hizentra does not need refrigeration.
  • You can do certain activities while you infuse.
  • Infuse Hizentra under your skin only; do not inject into a blood vessel.

Talk to your prescriber to see which individualized dosing option is right for you.

Learn More About:
New Dosing Options from Hizentra
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Hizentra is Safe and Effective

Demonstrated tolerability

  • 99.7% of local reactions were mild or moderate in intensity.
  • The most common drug-related adverse reactions (seen in 5% or more of subjects in the US clinical trial) were local reactions (swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.

Pediatrics to geriatrics

Hizentra is approved to treat various forms of primary immunodeficiency (PI) in patients age 2 and over.

Heritage

CSL Behring, a global leader in biotherapeutics, offers high quality immunoglobulin therapy to treat primary immunodeficiencies.

Convenience of Self-Administration

Hizentra 20% SCIg Therapy, available in four vial sizes - 10g 50mL, 4g 20mL, 2g 10mL, 1g 5mL

Self-administration

After you receive appropriate training, you will be able to self-administer Hizentra on the dosing schedule on which you have agreed.

The number of infusion sites used will vary based on dose, dosing schedule, and tolerability.

Four vial sizes

To accommodate the dose you need, Hizentra offers 4 vial sizes. The 10 g (50 mL) vial streamlines the infusion process and may reduce the number of vials you need.

30-month room temperature storage

When stored at room temperature (up to 25°C [77°F]), Hizentra is stable for up to 30 months, as indicated by the expiration date printed on the outer carton and vial label.

Hear Carla Duff, ARNP Discuss the Benefits of SCIg Therapy

“The fact that [SCIg therapy] fits into their lifestyle so easily is a great benefit to my patients.”

- Carla Duff, ARNP

Hear Prescribers Discuss Topics Surrounding SCIg Therapy

Your Patient's Single Source for Ig Solutions

Hizentra Co-Pay Relief Program

The Hizentra Co-Pay Relief program helps eligible patients afford their therapy by helping with monthly out-of-pocket expenses for Hizentra (up to $5,000 for one year, with no monthly cap).*

* This program applies to product costs only; however, assistance for infusion-related costs may be available through a nonprofit patient support organization. Contact IgIQ to learn more.

Other support services

IgIQ is a comprehensive resource center for people who depend on CSL Behring immune globulin (Ig) therapies.

IgIQ can help with:

  • Enrollment into other financial assistance and support programs, such as the CSL Behring AssuranceSM and CSL Behring Patient Assistance ProgramSM.
  • Providing important resources to patients.
Call 1-877-355-IGIQ (4447) Monday-Friday, 8 AM to 8 PM ET

MyHizentra™ Infusion Manager Journal App

Like Hizentra itself, the Infusion Manager app is flexible and designed to fit your lifestyle. You can use the app to manage your own infusions, and/or those of someone for whom you are a caregiver. You can also customize how you enter your infusion schedule and the time at which you would like to be reminded.

Important Safety Information
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Important Safety Information

WARNING: Thrombosis (blood clots) can occur with immune globulin products, including Hizentra. Risk factors can include: advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (blood thickness), use of estrogens, installed vascular catheters, and cardiovascular risk factors.

If you are at high risk of blood clots, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor for signs of clotting events and hyperviscosity. Always drink sufficient fluids before infusing Hizentra.

See your doctor for a full explanation, and the full prescribing information for complete boxed warning.

Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is a prescription medicine used to treat:

  • Primary immune deficiency (PI) in patients 2 years and older
  • Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Treatment with Hizentra might not be possible if your doctor determines you have hyperprolinemia (too much proline in the blood), or are IgA-deficient with antibodies to IgA and a history of hypersensitivity. Tell your doctor if you have previously had a severe allergic reaction (including anaphylaxis) to the administration of human immune globulin. Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction.

Inform your doctor of any medications you are taking, as well as any medical conditions you may have had, especially if you have a history of diseases related to the heart or blood vessels, or have been immobile for some time. Inform your physician if you are pregnant or nursing, or plan to become pregnant.

Infuse Hizentra under your skin only; do not inject into a blood vessel. Self-administer Hizentra only after having been taught to do so by your doctor or other healthcare professional, and having received dosing instructions for treating your condition.

Immediately report to your physician any of the following symptoms, which could be signs of serious adverse reactions to Hizentra:

  • Reduced urination, sudden weight gain, or swelling in your legs (possible signs of a kidney problem).
  • Pain and/or swelling or discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, or numbness/weakness on one side of the body (possible signs of a blood clot).
  • Bad headache with nausea; vomiting; stiff neck; fever; and sensitivity to light (possible signs of meningitis).
  • Brown or red urine; rapid heart rate; yellowing of the skin or eyes; chest pains or breathing trouble; fever over 100°F (possible symptoms of other conditions that require prompt treatment).

Hizentra is made 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 side effects in the clinical trials for Hizentra include redness, swelling, itching, and/or bruising at the infusion site; headache; chest, joint or back pain; diarrhea; tiredness; cough; rash; itching; fever, nausea, and vomiting. These are not the only side effects possible. Tell your doctor about any side effect that bothers you or does not go away.

Before receiving any vaccine, tell immunizing physician if you have had recent therapy with Hizentra, as effectiveness of the vaccine could be compromised.

Please see full prescribing information for Hizentra, including boxed warning and the patient product information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Patient/Caregiver About Hizentra Why Choose Hizentra
CSL Behring
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® and MyHizentra® are registered trademarks of CSL Behring AG.
Biotherapies for Life® is a registered trademark of CSL Behring LLC.
CSL Behring AssuranceSM, IgIQSM, and Premier StartSM are service marks of CSL Behring LLC.
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© 2018 CSL Behring LLC. The product information presented on this site is intended for US residents only. HIZ-0316-MAR18