KING OF PRUSSIA, Pa.,
Feb. 2, 2015 /PRNewswire/ -- CSL
Behring announced today that the U.S. Food and Drug Administration
(FDA) has expanded the administration options for Hizentra®,
Immune Globulin Subcutaneous (Human), 20% Liquid, to include the
ability to individualize therapy with flexible dosing – treatment
at regular intervals from daily to once every two weeks (biweekly)
– for people with primary immunodeficiency
(PI). Self-administered subcutaneously, Hizentra
delivers consistent levels of immunoglobulin G (IgG) regardless of
dosing schedule. Hizentra, the first and only 20
percent subcutaneous immunoglobulin, received FDA approval in
March 2010 as a once-weekly IgG
replacement therapy to help protect people with PI against
infections and was approved for biweekly (once every two weeks)
dosing in September 2013.
PI is a group of serious diseases that compromise the immune
system, leaving patients particularly vulnerable to infection.
Approximately 250,000 Americans (or one person per 1,200) have been
diagnosed with PI.
"Patient preferences on infusion frequency, time and volume can
differ for many reasons, so having a treatment option like
Hizentra that can be customized to fit individual lifestyles
is important to both patients and the physicians who treat them,"
said Ralph S. Shapiro, M.D.,
Director of the Midwest Immunology Clinic. "Most important,
flexible dosing options with Hizentra give PI patients the
freedom to manage their condition based on their specific needs,
while still providing a consistent level of protection against
infections."
FDA approval of flexible dosing for Hizentra is based on
pharmacometrics (modeling and simulation). Clinical trials using
these alternative Hizentra dosing regimens were not
conducted.
"CSL Behring understands that managing a life-long disorder can
be challenging as patients' lifestyles and treatment requirements
may change over time," said Bill
Campbell, Senior Vice President, North America Commercial
Operations, CSL Behring. "Offering PI patients the option of dosing
Hizentra at regular intervals from daily to once every two
weeks further underscores our commitment to providing treatment
options that improve patients' lives."
For more information about Hizentra individualized
therapy, please visit Hizentra.com/Individualize.
About Primary Immunodeficiencies
More than 200
types of PIs exist. For individuals with PI, many of them children,
infections may not improve as expected with usual treatments and
may even keep returning. As a result, patients may face repeated
rounds of antibiotics or hospitalization for treatment. Repeated
infections can lead to organ damage, which over time can become
life-threatening. Some infections, such as meningitis, can even
result in death.
For more information on PI, please visit www.Hizentra.com or
contact the leading PI patient advocate groups in the U.S., the
Immune Deficiency Foundation and the Jeffrey Modell
Foundation.
Important Safety Information
Immune Globulin
Subcutaneous (Human), Hizentra®, treats various forms of primary
immunodeficiency (PI) in patients age 2 and over.
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.
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 (depletion of blood red 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.
For full prescribing information for Hizentra, including
the boxed warning and the patient product information, visit
http://www.hizentra.com/consumer/prescribing-information.aspx.
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.
About CSL Behring
CSL Behring is a leader in the
plasma protein therapeutics industry. Committed to saving lives and
improving the quality of life for people with rare and serious
diseases, the company manufactures and markets a range of
plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat
coagulation disorders including hemophilia and von Willebrand
disease, primary immune deficiencies, hereditary angioedema and
inherited respiratory disease, and neurological disorders in
certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent
hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma
collection networks, CSL Plasma. CSL Behring is a global
biopharmaceutical company and a member of the CSL Group of
companies. The parent company, CSL Limited (ASX: CSL), is
headquartered in Melbourne,
Australia. For more information, visit
http://www.cslbehring.com/.
Media Contact:
Greg
Healy
CSL Behring
Office: 610-878-4841
Mobile: 610-906-4564
Greg.Healy@cslbehring.com
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SOURCE CSL Behring