Efficacy & Tolerability:
Ig Therapy You Can Trust

Hizentra is manufactured and distributed by CSL Behring, a global leader in the plasma protein biotherapeutics industry.

Established Efficacy

Hizentra provides proven protection against infection. In the US clinical trial, the rate of serious bacterial infections4 (SBIs) was 0 per subject-year, while the annual rate of infections was 2.76 per subject-year. This means that patients did not experience any serious infections (meaning pneumonia, bronchitis, etc). On average, all patients had fewer than 3 infections of any type per year.

The following is information from the US pivotal clinical study used by the FDA to approve Hizentra for PI therapy.

Annual Rates of Infection
Serious Bacterial Infections*

0
per subject-year

Any Infections

2.76
per subject-year

*Serious bacterial infections (SBIs) defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess


Hizentra US Clinical Study
Missed Days

2.06 missed days of work/school/daycare per subject-year due to infections

Hospitalizations

0.2 days of hospitalizations per subject-year due to infections

Adverse Reactions

In the US clinical trial for Hizentra, the most common adverse reactions to Hizentra were redness, swelling, itching, heat, or pain at the infusion site (ie, local site reactions). 93% were mild, while 6% were moderate. Other common side effects observed were headache, vomiting, pain, and fatigue.

Mild Local-Site Reaction

  • Minor swelling
  • Mild redness, itching, discomfort, and/or pain
Mild Local Site Reaction
24 hours after infusion*

Moderate Local-Site Reaction

  • Greater swelling than with a mild reaction
  • Moderate redness, itching, discomfort, and/or pain
Moderate Injection-site Reaction
24 hours after infusion*

*Photos are from the Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) phase 1 clinical trial.

Serious bacterial infections (SBIs), defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess

Ig Therapy Designed for Freedom
& Flexibility

Hizentra is a 20% SCIg therapy with multiple flexible dosing options, enabling you to infuse at regular intervals from daily up to every 2 weeks, depending on what fits your lifestyle. Hizentra is available in 4 vial sizes, including a 10 g (50 mL) vial.

Important Safety Information
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Important Safety Information

WARNING: Thrombosis (blood clotting) 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 thrombosis, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor you for signs of thrombosis and hyperviscosity. Always drink sufficient fluids before administration.

Immune Globulin Subcutaneous (Human), Hizentra®, treats various forms of primary immunodeficiency (PI) in patients age 2 and over.

Tell your doctor if you have had a serious reaction to other immune globulin medicines or have been told you also have a deficiency of the immunoglobulin called IgA, as you might not be able to take Hizentra. You should not take Hizentra if you know you have hyperprolinemia (too much proline in your blood).

Infuse Hizentra under your skin only; do not inject into a blood vessel.

Allergic reactions can occur with Hizentra. If your doctor suspects you are having a bad allergic reaction or are going into shock, treatment will be discontinued. Immediately tell your doctor or go to the emergency room if you have signs of such a reaction, including hives, trouble breathing, wheezing, dizziness, or fainting.

Tell your doctor about any side effects that concern you. Immediately report symptoms that could indicate a blood clot, including pain and/or swelling of an arm or leg, with warmth over affected area; discoloration in arm or leg; unexplained shortness of breath; chest pain or discomfort that worsens with deep breathing; unexplained rapid pulse; and numbness or weakness on one side of the body. Your doctor will also monitor symptoms that could indicate hemolysis (destruction of red blood cells), and other potentially serious reactions that have been seen with Ig treatment, including aseptic meningitis syndrome (brain swelling); kidney problems; and transfusion-related acute lung injury.

The most common drug-related adverse reactions in the clinical trial for Hizentra were swelling, pain, redness, heat or itching at the site of injection; headache; back pain; diarrhea; tiredness; cough; rash; itching; nausea and vomiting.

Hizentra is made from components of human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Before being treated with Hizentra, inform your doctor if you are pregnant, nursing or plan to become pregnant. Vaccines (such as measles, mumps and rubella) might not work well if you are using Hizentra. Before receiving any vaccine, tell the healthcare professional you are being treated with Hizentra.

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 Efficacy & Tolerability
CSL Behring
Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC.
Hizentra® is a registered trademark of CSL Behring AG.
© 2018 CSL Behring LLC. The product information presented on this site is intended for US residents only. HIZ/09-12-0016k(1) 9/2015