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] 20% Liquid).
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] 20% Liquid). CSL Behring now offers a full range of prefilled syringe sizes to meet the individual needs of people living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Hizentra is the first and only immune globulin (Ig) available in a simple, convenient and ready-to-use prefilled syringe. "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) About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) About Hizentra® 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), 20% Liquid, is a prescription medicine used to treat:
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:
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 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
SOURCE CSL Behring |
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