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. 2021 Dec 9;18(2):2006026. doi: 10.1080/21645515.2021.2006026

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