Table 3.
List of FDA approvedimmunoglobulin products in infectious diseases
| Product Name/ Manufacturer | Disease | Product formulation | Condition/s of disease therapy | Reference |
|---|---|---|---|---|
| Anthrasil (Cangene Corporation) |
Anthrax | Sterile solution of purified human IgG, stabilized with 10% maltose and 0.03% polysorbate 80 | Adult and pediatric patient of inhalational anthrax in combination with appropriate antimicrobial agent | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/anthrasil |
| BabyBiG (California Department of Public Health) |
Botulism | Sterile, lyophilized powder of IgG, stabilized with 5% sucrose and 1% human albumin | Infant botulism infected with type A and type B toxin | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/babybig |
| CytoGam (Saol Therapeutics Inc) |
Cytomegalovirus (CMV) | Liquid solution of IgG against CMV, stabilized by 5% sucrose and 1% Human Albumin | As a prophylactic measure to organs (kidney, lung, liver, pancreas and heart) transplant associated CMV infected patients. | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/cytogam |
| HepaGam B (Cangene Corp) And Nabi-HB (Nabi Biopharmaceuticals) |
Hepatitis B | Prepared from plasma donors with high-titers of anti-HBs and formulated as 5% protein solution with 10% maltose and 0.03% polysorbate 80 | As apreventive agent of Hepatitis B recurrence post liver transplantation in HBsAg-positive patients.Also, as post-exposure treatment to acute HBV Infected, HepB contaminated blood exposed, infants born to HepB positive mothers | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/hepagam-b |
| KEDRAB (Kamada Ltd.) |
Rabies | Liquid solution of anti-rabies purified IgG immunoglobulin, stabilized with 0.3 M glycine | Post-exposure prophylaxis of rabies infected patient, given promptly after contact with rabid animal and in combination with rabies vaccine. | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/kedrab |
| VariZIG (Cangene Corporation) |
Varicella-zoster virus | Lyophilized preparation of purified IgG, formulated as 0.04 M sodium 197 chloride, 0.1 M glycine and 0.01% polysorbate 80 | As a post-exposure prophylaxis in high risk individuals such as immunocompromised children and adults, newborns of mothers with varicella, infants below one-year age and pregnant women | https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/varizig |
| GamaSTAN S/D (Grifols Therapeutics Inc) |
Hepatitis A Measels Rubella |
Sterile solution of immunoglobulin, formulated as 15–18% protein and contains 0.21–0.32 M glycine as buffer | Used as a prophylactic measure in Hepatitis A, Measels and Rubella virus exposed person | https://www.fda.gov/media/86789/download |
| RespiGam (MedImmune Inc) |
Respiratory Syncytial Virus (RSV) | Pooled hyperimmune polyclonal immunoglobulins from donors with high titer anti-RSV antibodies | Discontinued since 2003 due to long intravenous infusion, high dosage volume and high risk to blood borne pathogens |
https://www.sec.gov/Archives/edgar/data/873591/0000873591-96-000038.txt https://www.intechopen.com/chapters/65931 |