Thursday, April 08, 2010

20% Sub-Q Ig Therapy — a first-in-class product from CSL Behring

CSL Behring received approval from the FDA in March to begin marketing Hizentra, a 20% subcutaneous formulation for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra, provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body.

Hizentra is the first 20% subcutaneous immunoglobulin (SCIg) approved in the U.S. by the FDA. This high-concentration product is stabilized with L-proline, a naturally-occurring amino acid which allows the medication to be stored at room temperature, offering patients and physicians convenience and portability. Hizentra can be safely self-administered by PI patients under a physician's care.

PI medications are typically intravenously infused and result in severe side effects and infusion site reactions. Now, PI patients have a new treatment option with the freedom to self-administer their IG therapy when and where it suits them.

2 comments:

scalesmd said...

All the therapies can have adverse events and reactions, this includes the new CSL product, Hizentra.

Most individuals DO NOT have serious reactions or adverse events to intravenous immunoglobulin (IVIG).

Some individuals may tolerate subcutaneous immunoglobulin (SCIG) better than IVIG, and there appears to be less of a risk of some of the more serious types of reactions such as anaphylaxis.

The current IVIG products on the market are all safe, effectiv,e and generally well tolerated.

Herrien said...

Nice post, thanks for sharing this wonderful and useful information with us.

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