FDA Warnings and Recalls
IVIg (Intravenous Immunoglobulin) is a blood product extracted from the plasma of about 10,000 to 20,000 blood donors per dose. It contains the pooled human immunoglobulin Type G (IgG) which are antibodies of the immune system. IVIg is used to treat immune deficiencies and autoimmune and inflammtory diseases.
The plasma that the immunoglobulins come from has been vigorously screened, tested and found to be safe and free of HIV infection and the hepatitis virus.
An IVIg treatment can take 2- 5 days, several hours a day. Its effect lasts between 2 weeks to 3 months. (Also see What is Scleroderma?, Medical Overview, and Medications for Scleroderma, Arthritis, Autoimmune and Rheumatic Diseases)
Intravenous immunoglobulins in systemic sclerosis: Data from a French nationwide cohort of 46 patients and review of the literature. Our work suggests that IVIG are a safe therapeutic option that may be effective in improving musculoskeletal involvement, systemic inflammation, digestive tract symptoms and could be corticosteroid sparing. PubMed, Autoimmun Rev, 02/13/2017.
Sustained benefit from intravenous immunoglobulin therapy for gastrointestinal involvement (GI) in systemic sclerosis (SSc). Sustained benefit from IVIG suggests a specific immunomodulatory effect on those with established SSc GI complications. PubMed, Rheumatology (Oxford), 08/28/2015. (Also see Gastrointestinal Involvement)
Intravenous Immunoglobulin (IVIG) May Be an Effective Therapy for Refractory, Active Diffuse Cutaneous Systemic Sclerosis (dcSSc). IVIG may be an effective adjunctive therapy for active dcSSc in patients failing other therapies. PubMed, J Rheumatol, 2015 Feb;42(2):236-42. (Also see Scleroderma Clinical Trials)
The role of intravenous immunoglobulin preparations in the treatment of systemic sclerosis. Some authors report good effect of intravenous immune globulins in patients with scleroderma. The less frequent side effects of IVIG in doses below or equal to 2g/kg/month divided in 5 consecutive days make IVIG a promising treatment of choice in scleroderma. PubMed, International Journal of Rheumatology, .
Prevention of excessive collagen accumulation by human intravenous immunoglobulin (IVIG) treatment in a murine model of bleomycin-induced scleroderma (SSc). These results suggest that IVIG treatment may inhibit macrophage recruitment to fibrotic sites by down regulating MCP-1 and TGF-Î² production, and thus could be a potential drug for managing fibrotic disorders such as SSc. PubMed, Clin Exp Immunol, .
The role of high-dose intravenous immunoglobulin (IVIg) in rheumatology. IVIG remains relatively safe compared with other immunosuppressive drugs. Headaches and fatigue are common side effects but fortunately the more severe problems such as aseptic meningitis, venous thromboembolism and acute renal failure remain rare. Rheumatology, .
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