Methods, systems, and apparatus for administering a monoclonal and/or polyclonal antibody treatment via rapid infusion

Abstract

Presented herein are methods, systems, and apparatus for administering a monoclonal and/or polyclonal antibody treatment via a rapid infusion device, e.g., for the treatment of a disease, e.g., a disease caused by a pathogen, e.g., for the treatment of COVID-19, caused by the virus SARS-CoV-2, or for the treatment of other conditions/diseases, such as neurological diseases, organ and/or tissue transplants, or certain forms of cancer, that require infusions of monoclonal and/or polyclonal antibodies.

1 . A method for administering a monoclonal and/or polyclonal antibody treatment via a rapid infusion device, the method comprising:
 administering by intravenous infusion a volume of solution comprising one or more monoclonal and/or polyclonal antibodies to a patient using a rapid infusion device, wherein the rapid infusion device comprises a pump and a tubing line or lines, wherein the tubing line or lines fluidly connect (i) an intravenous (IV) bag or other receptacle containing the volume of solution to the pump and (ii) the pump to the patient, for intravenous delivery of the volume of solution to the patient, wherein one, two, or all three of (a), (b), and (c), as follows, applies:   (a) the pump administers the volume of solution to the patient at a flow rate substantially faster than by gravity alone;   (b) the pump administers the volume of solution at a dosing rate of at least 35 mg of the one or more monoclonal and/or polyclonal antibodies per minute and/or at a total [mAb(s) and/or pAb(s)] concentration of less than or equal to 20 mg/mL [total mg mAb(s) and/or pAb(s) per mL IV solution]; and   (c) administration of the volume of solution to the patient is completed in no more than 30 minutes.   
     
     
         2 . The method of  claim 1 , wherein the one or more monoclonal and/or polyclonal antibodies comprises a monoclonal and/or polyclonal antibody (or cocktail of antibodies) for the treatment of one or more members selected from the group consisting of cancer, a neurological disease or condition; dermatitis; psoriasis; asthma or other respiratory disease; macular degeneration; an autoimmune disease; cytokine release syndrome; Castelman disease; a disease caused by a pathogen ; and organ and/or tissue transplant. 
     
     
         3 . The method of  claim 1 , wherein the one or more monoclonal and/or polyclonal antibodies comprises a member selected from the group consisting of the following: an anti-inflammatory; an anti-cancer; an anti-cancer and anti-viral; palivizumab; and abciximab. 
     
     
         4 . The method of  claim 1 , wherein the method is performed for the treatment of COVID-19. 
     
     
         5 . The method of  claim 1 , wherein the method is performed for the treatment of a neurological disease or condition. 
     
     
         6 . The method of  claim 1 , wherein the one or more monoclonal antibodies comprises one or more members selected from the group consisting of: pembrolizumab (Keytruda), manufactured by Merck for treatment of cancer; nivolumab (Opdivo), manufactured by Bristol Myers Squibb, for various forms of cancer; bevacizumab (Avastin), manufactured by Roche, for colorectal, lung, glioblastoma, kidney, cervical, and/or ovarian cancer; ocrelizumab (Ocrevus), manufactured by Roche, for relapsing or primary progressive multiple sclerosis; rituximab (Rituxan), manufactured by Roche, Pharmstandard, for various autoimmune diseases and cancers; daratumumab (Darzalex), manufactured by Janssen (Johnson & Johnson), for multiple myeloma; pertuzumab (Perjeta), manufactured by Roche, for HER2-positive breast cancer; trastuzumab (Herceptin), manufactured by Genentech (Roche), for breast, stomach, and esophageal cancer; infliximab (Remicade), manufactured by Janssen (Johnson & Johnson), for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis; tocilizumab (Actemra/RoActemra), manufactured by Roche, for rheumatoid arthritis, forms of juvenile idiopathic arthritis and giant cell arteritis as well as CAR T cell-induced severe or life-threatening cytokine release syndrome; atezolizumab (Tecentriq), manufactured by Roche, for urothelial carcinoma, non-small cell lung cancer, and triple-negative breast cancer; tositumomab-1131 (Bexxar), manufactured by GSK, for non-Hodgkin lymphoma; olaratumab (Lartruvo), manufactured by Eli Lilly, for soft tissue sarcoma; MabThera, rituximab (Rituxan), manufactured by Biogen/Genentech, for non-Hodgkin lymphoma; basiliximab (Simulect), manufactured by Novartis, for prevention of kidney transplant rejection; ibritumomab tiuxetan (Zevalin), manufactured by Spectrum, for non-Hodgkin lymphoma; cetuximab (Erbitux), manufactured by Bristol Meyers Squibb, Eli Lilly, and Merck, for colorectal cancer; natalizumab (Tysabri), manufactured by Biogen/Elan, for multiple sclerosis; panitumumab (Vectibix), manufactured by Amgen, for colorectal cancer; ranibizumab (Lucentix), manufactured by Genentech/Novartis, for macular degeneration; eculizumab (Soliris), manufactured by Alexion, for paroxysmal nocturnal hemoglobinuria; ofatumumab (Arzerra), manufactured by Novartis, for chronic lymphocytic leukemia; belimumab (Benlysta), manufactured by Human Genome Sciences, for systemic lupus erythematosus; ipilimumab (Yervoy), manufactured by Bristol Meyers Squibb, for metastatic melanoma; pertuzumab (Perjeta), manufactured by Genentech, for breast cancer; raxibacumab, manufactured by Human Genome Sciences, for anthrax infection; obinutuzumab (Gazyva, Gazyvaro), manufactured by Genentech, for chronic lymphocytic leukemia; siltuximab (Sylvant), manufactured by Janssen Biotech), for Castelman disease; ramucirumab (Cyramza), manufactured by Eli Lilly, for gastric cancer; vedolizumab (Entyvio), manufactured by Takeda, for ulcerative colitis, Crohn's disease; alemtuzumab (Lemtrada, MabCampath, Campath-1H), manufactured by Genzyme, for multiple sclerosis and chronic myeloid leukemia, necitumumab (Portrazza), manufactured by Eli Lilly, for non-small cell lung cancer; dinutuximab (Qarziba, Unituxin), manufactured by United Therapeutics, for neuroblastoma; elotuzumab (Empliciti), manufactured by Bristol Meyers Squibb, for multiple myeloma; reslizumab (Cinqaero, Cinqair), manufactured by Teva, for asthma; bezlotoxumab (Zinplava), manufactured by Merck Sharp Dohme, for prevention of  Clostridium difficile  infection recurrence; obiltoxaximab (Anthim), for prevention of inhalational anthrax; avelumab (Bavencio), manufactured by Merck, for Merkel cell carcinoma; and durvalumab (Imfinzi), manufactured by AstraZeneca, for bladder cancer. 
     
     
         7 . The method of  claim 1 , wherein the method is performed for the treatment of an organ and/or tissue transplant patient. 
     
     
         8 . The method of  claim 1 , wherein the rapid infusion device comprises a flow control value or other feature that limits flow of fluid to the patient to no greater than a predetermined maximum flow rate. 
     
     
         9 . The method of  claim 1 , wherein the rapid infusion device delivers the volume of solution to the patient at a rate that approximates a predetermined fixed rate. 
     
     
         10 . The method of  claim 1 , comprising using a disposable infusion set for connection to the rapid infusion device, wherein the disposable infusion set comprises one or more members of the group consisting of: a needle, one or more lengths of tubing, and an adhesive support. 
     
     
         11 . The method of  claim 1 , wherein the rapid infusion device comprises an elastomeric pump, wherein the pump comprises the receptacle containing the volume of solution, and wherein the tubing line or lines fluidly connect the pump and, therefore, the receptacle containing the volume of solution, to the patient, for intravenous delivery of the volume of solution to the patient. 
     
     
         12 . The method of  claim 1 , wherein the rapid infusion device comprises a heater and/or an air venting mechanism, wherein the rapid infusion device does not comprise dripping chambers or a drip pan as used in drip I.V. infusers. 
     
     
         13 . The method of  claim 1 , wherein the rapid infusion device comprises a filter for filtering out particles from the volume of solution prior to, and upstream of, delivery of the filtered solution to the patient. 
     
     
         14 . The method of  claim 13 , wherein the filter has a size small enough to catch the particles, wherein the filter has a size below 170 microns. 
     
     
         15 . The method of  claim 1 , wherein the rapid infusion device is portable and/or is designed for a single use. 
     
     
         16 . A rapid infusion device for administering by intravenous infusion a volume of solution comprising one or more monoclonal and/or polyclonal antibodies to a patient, the rapid infusion device comprising:
 a pump; and   a tubing line or lines, wherein the tubing line or lines fluidly connect (i) an intravenous (IV) bag or other receptacle containing the volume of solution to the pump and (ii) the pump to the patient, and wherein the pump is configured such that one, two, or all three of (a), (b), and (c), as follows, applies:   (a) the pump is capable of administering the volume of solution to the patient at a flow rate substantially faster than by gravity alone;   (b) the pump is capable of administering the volume of solution at a dosing rate of at least 35 mg of the one or more monoclonal and/or polyclonal antibodies per minute and/or at a total [mAb(s) and/or pAb(s)] concentration of less than or equal to 20 mg/mL, [total mg mAb(s) and/or pAb(s) per mL IV solution]; and   (c) the pump is capable of administering the volume of the solution in no more than 30 minutes.   
     
     
         17 . The rapid infusion device of  claim 16 , wherein the device comprises a flow control valve or other feature that limits flow of fluid to the patient to no greater than a predetermined maximum flow rate. 
     
     
         18 . The rapid infusion device of  claim 16 , wherein the rapid infusion device is capable of delivering the volume of solution to the patient at a rate that approximates a predetermined fixed rate. 
     
     
         19 . The rapid infusion device of  claim 16 , comprising a disposable infusion set, wherein the disposable infusion set comprises one or more members of the group consisting of: a needle, one or more lengths of tubing, and an adhesive support. 
     
     
         20 . The rapid infusion device of  claim 16 , wherein the rapid infusion device comprises an elastomeric pump, wherein the pump comprises the receptacle containing the volume of solution, and wherein the tubing line or lines fluidly connect the pump (and, therefore, the receptacle containing the volume of solution) to the patient, for intravenous delivery of the volume of solution to the patient. 
     
     
         21 . The rapid infusion device of  claim 16 , wherein the rapid infusion device comprises a heater and/or an air venting mechanism. 
     
     
         22 . The rapid infusion device of  claim 16 , wherein the rapid infusion device comprises a filter for filtering out particles from the volume of solution prior to, and upstream of, delivery of the filtered solution to the patient. 
     
     
         23 . The rapid infusion device of  claim 22 , wherein the filter has a size small enough to catch the particles wherein the filter has a size below 125 microns. 
     
     
         24 . The rapid infusion device of  claim 16 , wherein the rapid infusion device is portable and/or is designed for a single use, and wherein the rapid infusion device has a total weight less than 5 lbs. 
     
     
         25 . A kit for administering a monoclonal and/or polyclonal antibody treatment via a rapid infusion device for the treatment of a disease caused by the virus SARS-CoV-2, the kit comprising the rapid infusion device of  claim 16 .