Baxter Receives FDA Approval for Advate 4000 IU
Baxter International has received U.S. Food and Drug Administration approval for a 4,000 IU dosage of Advate (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free Method).
Infusion Environments: Comparing Costs, Safety and Privacy
When choosing a site of care for immune globulin therapy, each patient’s unique situation needs to be considered.
CSL’s rVlla-FP Granted Orphan Drug Designation
CSL Behring has been granted orphan drug designation by the U.S.Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP).
Understanding and Treating IG Side Effects
Knowing what side effects, from mild to serious, to expect during and after immune globulin infusions can prepare patients and their caregivers for treatment changes to mitigate their impact.
Slow Release of IG May Delay Alzheimer’s Disease
Recent studies suggest that the divergent outcomes in Alzheimer’s disease clinical studies of intravenous immune globulin (IVIG) may be due to differences in temporal administration and administered dosages.
Cangene Recalls HepaGam B Product Lots
Cangene Corp. has issued a voluntary recall of several finished product lots associated with one bulk lot of Hepatitis B Immune Globulin ([Human] HepaGam B > 312 IU/mL).
FDA Approves Advate to Treat Hemophilia A
The U.S. Food and Drug Administration approved Baxter International Inc.’s Advate (antihemophilic factor [recombinant] plasma/albumin free method) for hemophilia A.
Immune Globulin Therapy: The Investigational Frontier
IG is being successfully studied to treat more diseases than ever before, especially for hematological, neurological and autoimmune conditions.
Individual IG Dosing
Studies that examine the relationships between therapeutic doses of IG, trough IgG levels and infection rates shed new light on how IG replacement therapy should be prescribed for individuals.
Octagam 5% Returns to Market in U.S. and Europe
The U.S. Food and Drug Administration and the Committee for Medicinal Products for Human Use in Europe have approved the return of Octagam 5% (human normal immunoglobulin 50 mg/ml) to the market. Marketing authorization was suspended in August 2010 in the U.S.