TABLE 8.1.
Licensed U.S. Antibody Products for Passive Immunity to Infectious Diseases or Toxins
| Product | Brand Name | Manufacturer | Licensed Indicationsa |
|---|---|---|---|
| Standard Immunoglobulins (Human) | |||
| Immunoglobulin, intravenous | Bivigam Carimune Flebogamma Gammagard Gammaplex Gamunex-C Octagam Privigen |
Biotest Pharmaceuticals CSL Behring Instituto Grifols Baxter BPL Grifols Biotherapeutics Pharmazeutika Produktionsges CSL Behring |
Primary humoral immunodeficiency; multifocal motor neuropathy; chronic idiopathic thrombocytopenic purpura; Kawasaki syndrome; chronic inflammatory demyelinating polyneuropathy |
| Immunoglobulin, subcutaneous | Hizentra Hyqvia Gammagard Vivaglobin |
CSL Behring Baxter Baxter CSL Behring |
Primary humoral immunodeficiency; multifocal motor neuropathy |
| Immunoglobulin, intramuscular | GamaSTAN | Grifols Biotherapeutics | Hepatitis A; measles; varicella; rubella |
| Hyperimmunoglobulins (Human) | |||
| Anthrax immunoglobulin intravenous (human) | Anthrasil | Cangene Corporation | Treatment of inhalation anthrax |
| Botulism immunoglobulin intravenous (human) | BabyBIG | California Department of Health Services | Treatment of infant botulism (type A or type B Clostridium botulinum) |
| Cytomegalovirus immunoglobulin intravenous (human) | CytoGam | CSL Behring | Prophylaxis of cytomegalovirus (CMV) disease associated with organ transplantation |
| Hepatitis B immunoglobulin intravenous (human) | HepaGam B Nabi-HB |
Cangene Corporation Nabi Biopharmaceuticals |
Prevention and postexposure prophylaxis for hepatitis B |
| Rabies immunoglobulin (human) | HyperRab S/D | Grifols Biotherapeutics | Postexposure treatment of rabies, administered in conjunction with the rabies vaccine |
| Tetanus immunoglobulin (human) | HyperTET S/D | Grifols Biotherapeutics | Prophylactic or therapeutic treatment of tetanus |
| Vaccinia immunoglobulin intravenous (human) | N/A | Cangene Corporation | Treatment and/or modification of complications resulting from smallpox vaccination |
| Varicella zoster immunoglobulin (human) | VariZIG | Cangene Corporation | Varicella postexposure prophylaxis in high-risk groups |
| Animal-Derived Immunoglobulin Products | |||
| Antivenin (Latrodectus mactans) (equine) | Black widow spider antivenin | Merck & Co, Inc. | Treatment of bites by the black widow spider (Latrodectus mactans) |
| Botulism antitoxin bivalent (equine) types A and B | N/A | Sanofi Pasteur Ltd | Treatment of botulism (types A or type B) |
| Botulism antitoxin heptavalent (A, B, C, D, E, F, G)-(equine) | BAT | Cangene Corporation | Treatment of botulism (types A, B, C, D, E, F, or G) |
| Centruroides (scorpion) immune F(ab')2 (equine) injection | Anascorp | Rare Disease Therapeutics, Inc. | Treatment of scorpion envenomation |
| Crotalidae immune F(ab')2 (equine) | Anavip | Instituto Bioclon S.A. de C.V. | Treatment of rattlesnake envenomation |
| Crotalidae polyvalent immune Fab (ovine) | CroFab | Protherics, Inc. | Treatment of rattlesnake and cottonmouth/water moccasin envenomation |
| Digoxin immune Fab (ovine) | DigiFab | Protherics, Inc. | Treatment of digoxin toxicity or overdose |
| Diphtheria antitoxin (equine) | DAT | Instituto Butantab | Prophylactic or therapeutic treatment of diphtheria |
| Monoclonal Antibodies | |||
| Palivizumab | Synagis | MedImmune | Prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high-risk children |
| Raxibacumab | N/A | Human Genome Sciences/GlaxoSmithKline | Treatment of inhalation anthrax |
N/A, not applicable.
a
Indications as listed by the manufacturer. Indications have been grouped for each product type.
b
Distributed by the Centers for Disease Control and Prevention to physicians as an Investigational New Drug.