United States Only—Important Information About Vivaglobin®
January 28, 2011
King of Prussia, PA — 28 January 2011
Re: United States Only—Important Information About Vivaglobin®
Dear Valued Customer,
In March 2010, CSL Behring was pleased to receive United States Food and Drug Administration
approval of Hizentra®, the first and only 20 percent subcutaneous immunoglobulin
(SCIg) in the United States. Indicated as replacement therapy for patients with
primary humoral immunodeficiency, Hizentra is safe, effective and convenient. Hizentra
has proven to be of tremendous benefit to many people and demand for it continues
to increase steadily and quickly.
We encourage you to transition from Vivaglobin® to Hizentra if you haven’t already
done so because Vivaglobin manufacturing for the United States will end by the close
of this calendar year.
To ensure an even more robust and steady supply of immunoglobulin therapy, CSL Behring
has made major investments to further upgrade our state-of-the-art Hizentra manufacturing
facility in Bern, Switzerland.
We look forward to continuing to provide the primary immunodeficiency community
in the United States with Hizentra—an innovative, high concentration and portable
Please see Important Safety Information for Hizentra and Vivaglobin below, and follow
the links to full prescribing information for each product.
As always, we thank you for your continued trust in CSL Behring and in our lifesaving
Senior Vice President
North America Commercial Operations
Important Safety Information
Immune Globulin Subcutaneous (Human), Hizentra®
, and Immune Globulin Subcutaneous (Human), Vivaglobin®
, are indicated as replacement therapy for patients with primary humoral immunodeficiency (PI). This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Hizentra and Vivaglobin are contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or their components. Because it contains the stabilizer L-proline, Hizentra is also contraindicated in patients with hyperprolinemia. Both treatments are contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.
Hizentra and Vivaglobin should be administered subcutaneously only. Do not administer intravenously.
All IgA-deficient patients with anti-IgA antibodies are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration of these treatments immediately and treat as medically appropriate.
Hizentra and Vivaglobin are derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
The most common drug-related adverse reactions with Hizentra (observed in 5% or more of subjects in the clinical trial) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue.
The most common drug-related adverse reactions with Vivaglobin (observed in 5% or more of subjects in the clinical trial) were local injection-site reactions (eg, swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorders.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIg treatment and treatment with Vivaglobin, and might also occur with Hizentra. AMS is usually evidenced within 2 days of administration. Also monitor patients for other reactions reported to occur with IVIg treatment that might also occur with Vivaglobin or Hizentra, including renal dysfunction/failure, thrombotic events, hemolysis, and transfusion-related acute lung injury (TRALI).
Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.
Please see full prescribing information for Hizentra.
Please see full prescribing information for Vivaglobin.
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.