April 4, 2011
Re: A Message from CSL Behring to Current Vivaglobin® Patients
in the United States
Dear Valued Customer,
In January 2011, CSL Behring announced its intention to discontinue Vivaglobin®
in the United States market by year end. Due to the current delays we are experiencing
in Vivaglobin® supply, we feel it would be disruptive to bring the
product back temporarily, only to discontinue it later this year. Therefore, we
are writing to inform you that CSL Behring has decided to discontinue Vivaglobin®
in the United States effective today.
CSL Behring also manufactures Hizentra®, another innovative subcutaneous
immunoglobulin. Hizentra® is the first and only 20 percent subcutaneous
immunoglobulin (SCIg) in the United States that is indicated as replacement therapy
for patients with primary humoral immunodeficiency. Please visit www.Hizentra.com
to learn more.
If you are a current Vivaglobin® patient or caregiver of a Vivaglobin®
patient, speak with your healthcare provider about Hizentra® or other
immunoglobulin (Ig) therapy options that may be appropriate. To help you make the
transition to Hizentra®, CSL Behring is offering a Hizentra®
sample program. This program is designed to offer Vivaglobin® patients
a one-month supply of Hizentra® to determine if Hizentra®
is right for them. We encourage you to contact IgIQ (1-877-355-IgIQ) for more information.
Please see Important Safety Information for Hizentra® and Vivaglobin®
below, and the enclosed full prescribing information for each product.
Thank you for your continued trust in CSL Behring and in our life-saving therapies.
Sincerely,
Lynne Powell
Senior Vice President
North America Commercial Operations
Click here for information if you are a Health Care Professional.
Important Safety Information
Hizentra and Vivaglobin are indicated for the treatment of various forms of primary
immunodeficiency (PI).
If you have a history of anaphylactic or severe systemic response to immune globulin
preparations or selective immunoglobulin A deficiency, check with your physician,
as you should not use Hizentra or Vivaglobin.
Hizentra and Vivaglobin are to be infused under your skin only; do not inject into
a blood vessel.
Hypersensitivity reactions may occur with Hizentra or Vivaglobin. If you have antibodies
to IgA, you face a greater risk of developing severe hypersensitivity or going into
shock. If your physician suspects you are having a negative reaction or are going
into shock, treatment will be discontinued. Because Hizentra contains proline, you
cannot be treated with Hizentra if you have hyperprolinemia (a high level of proline
in your blood).
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 (seen in 5% or more
of subjects in the clinical trial) were local reactions (swelling, redness, heat,
pain, and itching at the injection site), headache, vomiting, pain, and fatigue.The
most common drug-related adverse reactions with Vivaglobin (seen in 5% or more of
subjects in the clinical trial) were injection-site reactions (eg, swelling, redness,
and itching), headache, nausea, rash, reduced strength and energy, and gastrointestinal
disorders.
Your physician will monitor for potentially serious reactions associated with intravenous
immunoglobulin treatment that might also occur with Hizentra or Vivaglobin, including
aseptic meningitis syndrome (AMS), renal dysfunction/failure, osmotic nephropathy,
thrombotic events, hemolysis, and transfusion-related acute lung injury (TRALI).
Ig administration may impair the effect of virus vaccines, such as measles, mumps
and rubella. Before getting any vaccination, inform your doctor that you are using
Hizentra or Vivaglobin.
Please read full Prescribing Information and Patient Product Information for Vivaglobin.
Please read full Prescribing Information and Patient Product Information for Hizentra.
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.