Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis

Exclusion Criteria

• •MGFA grade V within 6 months of screening.
• •A history of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
• •Other major chronic or debilitating illnesses within six months prior to study entry.
• •Female patients who are premenopausal and are: (a) pregnant on the basis of a serum pregnancy test, (b) breast-feeding, or (c) not using an effective method of double barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) birth control (birth control pills, male condom, female condom, intrauterine device, Norplant, tubal ligation, or other sterilization procedures).
• •Altered levels of consciousness, dementia, or abnormal mental status.
• •Thymectomy in the previous three months.
• •Evidence of renal insufficiency (Cr\>1.5 x elevated) or liver disease (transaminases \> 2.5 x elevation) at screening.
• •Skin disease that would interfere with assessment of injection site reaction
• •History of severe reactions to IVIg or SCIg.
• •Participation in a research study within the last 3 months
• •Treatment with rituximab or other biologics within 12 months of study entry
• •Inability to provide informed consent.
• •History of thrombotic episodes within the last year prior to enrollment
• •Known allergic or other severe reactions to blood products including intolerability to previous normal human immunoglobulin for intravenous administration (IVIG) and/or subcutaneous immunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reaction.
• •History of IgA deficiency or evidence of IgA deficiency at screening.