CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe
CSL Behring announced FDA approval for a 50mL prefilled syringe of Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) on April 18, 2023. Hizentra is the first immune globulin available in prefilled syringes, offering convenience for patients with Primary Immunodeficiency (PI) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The new size expands options for self-administration, decreasing treatment burden. Hizentra remains the most prescribed treatment for PI in the U.S. and is the only one approved for CIDP. Available in early 2024, the new syringe size joins existing 5mL, 10mL, and 20mL versions. CSL Behring aims to meet the anticipated demand for this innovative delivery method.
- FDA approval of new 50mL prefilled syringe for Hizentra improves patient convenience.
- Hizentra remains the most prescribed immune globulin treatment for PI in the U.S.
- Expands options for self-administration, allowing patients to manage their treatment flexibly.
- Potential risks of thrombosis and other severe adverse events may affect patient compliance.
- Hizentra® is the first and only immune globulin (Ig) available in prefilled syringes, offering those living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) a simple, convenient and ready-to-use option
KING OF PRUSSIA, Pa., April 18, 2023 /PRNewswire/ -- Global biotechnology leader CSL Behring today announced the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm prefilled syringe for Hizentra® (Immune Globulin Subcutaneous [Human]
"When managing a life-long rare disease or chronic condition, it is important to have treatment options that offer flexibility and convenience as a person's needs can change over time," said Lisa Butler, Executive Director, GBS|CIDP Foundation. "Having prefilled syringes available that allow people with conditions such as CIDP to administer their treatment at home, on their schedule, can help decrease treatment burden."
Hizentra is the most prescribed self-infused subcutaneous immune globulin (SCIg) treatment for PI in the U.S. and the first and only SCIg treatment approved for CIDP. The 50mL prefilled syringe will be available in early 2024, which will allow CSL Behring to manufacture supply to meet anticipated demand. Hizentra will continue to be available in 5mL, 10mL and 20mL prefilled syringes as well as in 5mL, 10mL, 20mL, and 50mL vials.
"As part of our promise to meet the needs of people who rely on our life-saving therapies, we recognize the important value of offering people with PI or CIDP a larger prefilled syringe size option to effectively manage their condition," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. "We are proud to be at the forefront of delivering effective treatment options that also provide flexibility by allowing those with PI or CIDP to self-administer their treatments based on their specific needs and lifestyles."
For more information on Hizentra, visit please visit Hizentra.com.
About Primary Immunodeficiency (PI)
PI diseases are a group of more than 450 rare, chronic disorders in which part of the body's immune system is missing or malfunctioning. Patients with PI commonly have frequent infections, reoccurring infections, infections that won't go away or unusually severe infections. As a result, patients may face repeated courses of antibiotics or be hospitalized for treatment. Many people living with PI have missed school, work or time with family and friends due to their PI.
About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP effects can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. The GBS|CIDP Foundation estimates that approximately 30 percent of CIDP patients progress to wheelchair dependence if not treated. The Foundation also estimates that the incidence of CIDP in the U.S. is as high as two in 100,000 people each year, with the accumulation of cases over time resulting in prevalence as high as nine in 100,000 in some areas.
About Hizentra®
Registered in more than 60 countries, Hizentra is the most prescribed subcutaneous immunoglobulin for primary immunodeficiency (PI) in the U.S. It has a proven track record of safety, efficacy, and tolerability. Hizentra was first approved by the U.S. FDA in March 2010 for the treatment of patients with PI and was approved in March 2018 for the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. For more information about Hizentra, including the U.S. prescribing information, visit www.hizentra.com.
Important Safety Information (ISI)
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),
- 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.
You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring.
Media Contact
Etanjalie Ayala
Mobile: +1 610 297 1069
Email: etanjalie.ayala@cslbehring.com
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