RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire-FirstCall/ —
Talecris Biotherapeutics (Nasdaq:
TLCR) announced today that the U.S. Food and Drug
Administration (FDA) approved Gamunex®-C (Immune Globulin
Injection [Human], 10% Caprylate/Chromatography Purified) for
subcutaneous administration in the treatment of primary
The newly approved Gamunex-C provides both the intravenous route
of administration and a new subcutaneous route of administration.
The intravenous delivery mode is approved to treat PI, chronic
inflammatory demyelinating polyneuropathy (CIDP), and idiopathic
thrombocytopenic purpura (ITP). The subcutaneous mode is approved
to treat only PI.
The difference between Gamunex and Gamunex-C is the labeling and
packaging information. Gamunex-C labeling describes both the
intravenous and subcutaneous routes of administration, whereas
Gamunex labeling describes only intravenous administration.
Subcutaneous administration delivers the product under the skin
into the subcutaneous tissue and intravenous administration is
delivered through a vein.
“The FDA approval of Gamunex-C is important because it provides
another option for patients with primary immunodeficiency and their
healthcare professionals when they are considering the various
treatment modalities,” said Fred Modell, Co-Founder of the Jeffrey
Modell Foundation. “We consider it significant for patients to have
multiple modes of delivery so they can select the option that best
suits their individual needs.”
Through its FDA approval, Gamunex-C becomes the first and only
immunoglobulin therapy approved in the U.S. with both intravenous
and subcutaneous routes of administration to treat PI. In clinical
studies of Gamunex-C, the most common adverse reactions associated
with subcutaneous administration were infusion site reactions,
headache, fatigue, ar