Methods for immune globulin administration

Abstract

Methods for administering immune globulin and devices for use thereof. The methods may generally include measuring a patient's hemolysis levels and determining whether the patient is suitable for immune globulin treatment, determining whether immune globulin treatment should be continued, and/or determining if the dose needs to be changed.

1 . A method of adjusting immune globulin administration to a patient, comprising:
 administering a dose of immune globulin to the patient;   monitoring hemolysis in the patient; and   adjusting the dose of administered immune globulin based on the monitored hemolysis.   
     
     
         2 . The method of  claim 1 , wherein monitoring the hemolysis in the patient comprises obtaining an end-tidal carbon monoxide level from the patient according to a monitoring protocol, and wherein adjusting the dose of administered immune globulin comprises adjusting the dose based on the end-tidal carbon monoxide level. 
     
     
         3 . The method of  claim 2 , wherein the monitoring protocol comprises obtaining the end-tidal carbon monoxide level from the patient at a set time after immune globulin administration. 
     
     
         4 . The method of  claim 3 , wherein the set time is about 15 minutes. 
     
     
         5 . The method of  claim 3 , wherein the set time is about 30 minutes. 
     
     
         6 . The method of  claim 2 , wherein the monitoring protocol comprises obtaining the end-tidal carbon monoxide level from the patient at set intervals during immune globulin administration. 
     
     
         7 . The method of  claim 6 , wherein obtaining the end-tidal carbon monoxide level from the patient at set intervals comprises obtaining the end-tidal carbon monoxide level from the patient every hour. 
     
     
         8 . The method of  claim 2 , wherein the monitoring protocol comprises obtaining the end-tidal carbon monoxide level from the patient when the dose of administered immune globulin is changed. 
     
     
         9 . The method of  claim 2 , wherein the monitoring protocol comprises obtaining the end-tidal carbon monoxide level from the patient after completion of administration of the dose of immune globulin. 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The method of  claim 2 , wherein the end-tidal carbon monoxide level is obtained using a portable breath analyzer. 
     
     
         13 . The method of  claim 2 , further comprising measuring a baseline end-tidal carbon monoxide level of the patient prior to administration of the dose of immune globulin. 
     
     
         14 . The method of  claim 13 , wherein adjusting the dose of administered immune globulin comprises ending administration of the dose of immune globulin if the end-tidal carbon monoxide level obtained during administration is increased by about 0.5 ppm above the baseline end-tidal carbon monoxide level. 
     
     
         15 . (canceled) 
     
     
         16 . The method of  claim 2 , wherein obtaining an end-tidal carbon monoxide level from the patient comprises:
 drawing a flow of air from the breath of a patient;   monitoring the carbon dioxide level of the flow of air;   identifying a point of transition between an increasing carbon dioxide level and a decreasing carbon dioxide level in the flow of air, the point of transition representative of a change from exhalation to inhalation in the breath of the patient;   upon identification of the transition point, isolating a sample volume of the flow of air drawn prior to the transition point; diverting a continued flow of air past the isolated sample volume;   monitoring the carbon dioxide level of the continued flow of air to confirm the change from exhalation to inhalation in the breath of the patient;   upon confirmation of the change from exhalation to inhalation in the breath of the patient, diverting the continued flow of air to displace the isolated sample volume through at least one gas measurement component; and   measuring using a gas analyzer, the carbon monoxide level in the isolated sample volume.   
     
     
         17 . The method of  claim 1 , further comprising measuring a baseline hemolysis level of the patient prior to administration of the dose of immune globulin. 
     
     
         18 . The method of  claim 17 , wherein the adjusting the dose of administered immune globulin comprises ending administration of the dose of immune globulin if the monitored hemolysis level increases by a set amount above the baseline hemolysis level. 
     
     
         19 . The method of  claim 1 , wherein the immune globulin is administered intravenously. 
     
     
         20 . The method of  claim 1 , wherein the immune globulin is administered intramuscularly. 
     
     
         21 . The method of  claim 1 , wherein the dose of immune globulin comprises IgG antibodies. 
     
     
         22 . The method of  claim 1 , wherein the dose of immune globulin comprises anti-D IgG antibodies. 
     
     
         23 . The method of  claim 1 , wherein the method is used for an indication selected from the group consisting of allogeneic bone marrow transplant, chronic lymphocytic leukemia, common variable immunodeficiency (CVID), idiopathic thrombocytopenic purpura, pediatric HIV, adult HIV, primary immunodeficiencies, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy (CIDP), kidney transplant, alzheimer's disease, autism, Bechet's disease, capillary leak syndrome, chronic fatigue syndrome,  Clostridium difficile  colitis, dermatomyositis, polymyositis, Grave's ophthalmopathy, Guillain-Barre syndrome, Kimura disease, inclusion body myositis, infertility, Lambert-Eaton syndrome, Lennox-Gastaut, lupus erythematosus, multifocal motor neuropathy, multiple sclerosis, muscular dystrophy, myasthenia gravis, neonatal alloimmune thrombocytopenia, parvovirus B19 infection, pemphigus, post-transfusion purpura, renal transplant rejection, Sjogren's syndrome, stiff person syndrome, Susac's syndrome, opsoclonus myoclonus, sepsis, toxic epidermal necrolysis, and multiple myeloma. 
     
     
         24 - 29 . (canceled)