Status: approved; marketed

Organizations involved:

Talecris Biotherapeutics Inc. – Manuf.; R&D; Tech.; USA mark.

Instituto Grifols, S.A. - Parent

NPS Pharmaceuticals Inc – Former

Bayer Corp. – Former

Bayer Schering Pharma AG – Intl. mark.

New York Blood Center, Inc. – Tech.

Cross ref: See Immune Globulin Products (entry #743).

Description: GamaSTAN S/D (formerly BayGam) is human plasma-derived immune globulin for intramuscular administration, with manufacturing including viral inactivation by the solvent-detergent method and heating to 30°C (wet pasteurization). GamaSTAN S/D contains 15-18% protein solution at a pH of 6.4-72 in 0.21-0.32 M glycine. GamaSTAN S/D is packaged in single-dose vials containing either 2 or 10 mL. The product is stored at 2-8˚C (refrigerated). GamaSTAN S/D contains no preservative.

Nomenclature: Immune Globulin (IGIM)/Talecris [BII]; GamaSTAN S/D [TR]; BayGam [TR former]; Immune Globulin (Human) [FDA; USP; INN]; IGIM [SY]; gamma globulin, intramuscular [SY]; immune globulin, intramuscular [SY]; immune serum globulin [SY]; NDC 0026-0635-02; NDC 0026-0635-04; NDC 0026-0635-10; NDC 0026-0635-12 [NDCs for BayGam]; NDC 13533-635-02;13533-635-04; 13533-635-10; 13533-635-12 [NDCs for GamaSTAN S/D]

Companies.: BayGam (now GamaSTAN S/D) was developed and manufactured by Bayer Corp., CBER/FDA est. 0008). BayGam was marketed by Bayer Corp. in the U.S., and internationally by Bayer AG and affiliates. In April 2005, Talecris Biotherapeutics Inc., a subsidiary of NPS Pharmaceuticals Inc., acquired the blood/plasma products business of Bayer, including manufacturing and U.S marketing, with Bayer AG, now Bayer Schering Pharma AG, retaining international marketing.

In Feb. 2011, Grifols S.A./Instituto Grifols acquired Talecris Biotherapeutics.

Manufacture: The immune globulin is obtained by cold ethanol (Cohn) fractionation of plasma. The solubilized Cohn fraction II is isolated and viral inactivation is performed by adjusting the concentration to contain 0.3% tri-n-butyl phosphate (TNBP; solvent) and 0.2% sodium cholate (detergent), and the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. The reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. GamaSTAN S/D is formulated to contain 15-18% protein solution at a pH of 6.4-72 in 0.21-0.32 M glycine. GamaSTAN S/D is then incubated in its final containers for 21-28 days at 20-27˚C. GamaSTAN S/D contains no preservatives.

Significant physical removal of model and non-enveloped viruses is obtained at two steps in the Cohn fractionation (leading to Fraction II): the precipitation and removal of Fraction II in the processing of Fraction II plus IIIW suspension to Effluent II and the filtration step in the processing of Effluent III to Fraction III (referring to particular fractions/step in the cold ethanol fractionation process). The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for GamaSTAN S/D has been validated in laboratory studies. Model viruses used included HIV-1; bovine viral diarrhea virus (BVDV) as a model for hepatitis C virus; pseudorabies virus (PRV) as a model for hepatitis B virus and herpesviruses; and reo virus type 3 (Reo) as a model for non-enveloped viruses and for its resistance to physical and chemical inactivation

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date= 19440111; First approval, PLA

Indications: = [full text of the "INDICATIONS AND USAGE” section of product insert/labeling; 4/2004]:

Hepatitis A: The prophylactic value of GamaSTAN S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN S/D is only indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

Measles (Rubeola): GamaSTAN S/D should be given to prevent of modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated or has not had measles previously. GamaSTAN S/D may be especially indicated for susceptible household contacts of measles patients, particularly under 1 year of age, for whom the risk of complications is greatest. GamaSTAN S/D and measles vaccine should not be given at the same time. If a child is older than 12 months and has received GamaSTAN S/D, he should be give measles vaccine about 3 months later when the measles antibody titer will have disappeared. If a susceptible child exposed to measles is immunocompromised, GamaSTAN S/D should be give immediately. Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.

Varicella: Passive immunization against varicella is immuno-compromised patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZVIG]. If VZVIG is unavailable. GamaSTAN S/D, promptly given, may also modify vari-cel-la.

Rubella: The routine use of GamaSTAN S/D for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified. Some studies suggest that the use of GamaSTAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN S/D may benefit those women who will not consider a therapeutic abortion.

Immunoglobulin deficiency: In patients with immunoglobulin deficiencies, GamaSTAN S/D may prevent serious infection. However, GamaSTAN S/D may not prevent chronic infections of the external secretory tissues such as the respiratory and gastrointestinal tract. Prophylactic therapy, especially against infections due to encapsulated bacteria, is effective in Bruton-type, sex-linked, congenital agammaglobulinemia associated with thyoma, and acquired agammaglobulinemia.

Tech. transfer: Solvent detergent viral inactivation technology was nonexclusively licensed from the New York Blood Center.. e.g,, see U.S. patent 4,820,805. See the entry for Pooled Plasma, Solvent Detergent Treated (SD Plasma) (#799) for further information about solvent detergent viral inactivation, used primarily for inactivation of enveloped viruses (e.g., HIV, hepatitis B and C viruses).

Market: The 2004 Average Wholesale Price (AWP) is $30.60/2mL and $128.13/10 mL (Red Book, 2004).

In its March 22, 2006 price list, FFF Enterprises reported its price as $25.55/2 mL vial; and $101.51/10 mL vial ($97.55 in 2005; $88.69 in 2004).