NDC 13533-335 Gamastan

Immune Globulin (human)

NDC Product Code 13533-335

NDC CODE: 13533-335

Proprietary Name: Gamastan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Immune Globulin (human) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to provide protection (antibodies) against certain virus infections (hepatitis A, measles, chickenpox, rubella) in people who have not been vaccinated or have not had the infection before. It is also used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a certain immune system problem (immunoglobulin deficiency). This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies), which help fight infections. Routine vaccination is usually the best way to protect against infection. Talk with your doctor about a recommended vaccination schedule.

NDC Code Structure

NDC 13533-335-04

Package Description: 1 VIAL in 1 CARTON > 2 mL in 1 VIAL (13533-335-40)

NDC 13533-335-12

Package Description: 1 VIAL in 1 CARTON > 10 mL in 1 VIAL (13533-335-13)

NDC Product Information

Gamastan with NDC 13533-335 is a a plasma derivative product labeled by Grifols Usa, Llc. The generic name of Gamastan is immune globulin (human). The product's dosage form is injection, solution and is administered via intramuscular form.

Labeler Name: Grifols Usa, Llc

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Plasma Derivative What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gamastan Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HUMAN IMMUNOGLOBULIN G .165 g/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
  • Antigen Neutralization - [MoA] (Mechanism of Action)
  • Immunoglobulins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Grifols Usa, Llc
Labeler Code: 13533
FDA Application Number: BLA101134 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-05-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Gamastan Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Warning: Thrombosis

Thrombosis may occur with immune globulin products, including GamaSTAN S/D. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. (see PRECAUTIONS: Thrombosis, PRECAUTIONS: Information for Patients) For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN S/D. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (see PRECAUTIONS: Thrombosis, DOSAGE AND ADMINISTRATION)

Description

Immune Globulin (Human) — GamaSTAN® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of immune globulin for intramuscular administration; it is preservative-free and latex-free. GamaSTAN S/D is prepared by cold ethanol fractionation from human plasma. The immune globulin is isolated from solubilized Cohn fraction II. The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. GamaSTAN S/D is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. GamaSTAN S/D is then incubated in the final container for 21–28 days at 20–27°C.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. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Fraction II: the precipitation and removal of Fraction III in the processing of Fraction II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.  Inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.(11-14) Studies of the GamaSTAN S/D manufacturing process demonstrate that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process (6.7 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

Clinical Pharmacology

Peak levels of immunoglobulin G are obtained approximately 2 days after intramuscular injection of GamaSTAN S/D.(1) The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.(2)Passive immunization with GamaSTAN S/D modifies hepatitis A and prevents or modifies measles. GamaSTAN S/D is not standardized with respect to antibody titers against hepatitis B surface antigen (HBsAg) and should not be used for prophylaxis of viral hepatitis type B. Prophylactic treatment to prevent hepatitis B can best be accomplished with use of Hepatitis B Immune Globulin (Human), often in combination with Hepatitis B Vaccine.(3)GamaSTAN S/D may be of benefit in women who have been exposed to rubella in the first trimester of pregnancy and who will not consider a therapeutic abortion.(4) GamaSTAN S/D may also be considered for use in immunocompromised patients for passive immunization against varicella if Varicella-Zoster Immune Globulin (Human) is not available.(5)Immune Globulin (Human) is not indicated for routine prophylaxis or treatment of rubella, poliomyelitis, mumps, or varicella. It is not indicated for allergy or asthma in patients who have normal levels of immunoglobulin.(6)In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB® S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

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 not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

GamaSTAN S/D in a dose of 0.05 mL/lb (0.1 mL/kg) is recommended for household and institutional hepatitis A case contacts.The following doses of GamaSTAN S/D are recommended for persons who plan to travel in areas where hepatitis A is common.(18-19) Length of StayDose VolumeUp to 1 month0.1 mL/kgUp to 2 months0.2 mL/kg2 months or longerRepeat dose of 0.2 mL/kg every 2 months

Measles (Rubeola)

To prevent or modify measles give GamaSTAN S/D in a susceptible person exposed fewer than 6 days previously.(7) A susceptible person is one who has not been vaccinated and has not had measles previously. GamaSTAN S/D may be especially indicated for susceptible household contacts of measles patients, particularly contacts under 1 year of age, for whom the risk of complications is highest.(7) GamaSTAN S/D and measles vaccine should not be given at the same time.(7) If a child is older than 12 months and has received GamaSTAN S/D, he should be given 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 given immediately.(8)Do not administer measles vaccine or any other live viral vaccine to children who are immunocompromised.

Give GamaSTAN S/D in a dose of 0.11 mL/lb (0.25 mL/kg) to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(7)To a susceptible child who is exposed to measles and who is immunocompromised, administer a dose of 0.5 mL/kg (maximum dose, 15 mL) of GamaSTAN S/D immediately.(8)

Varicella

Passive immunization against varicella in immunosuppressed patients is best accomplished by use of Varicella-Zoster Immune Globulin (Human) [VZIG]. If VZIG is unavailable, GamaSTAN S/D, promptly given, may also modify varicella.(5)

If Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.(5) For patients at risk of thrombosis, administer GamaSTAN S/D at the lower range of the recommended dose.

Rubella

The routine use of GamaSTAN S/D for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.(6) 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.(4)

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 at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.(4)

Contraindications

Do not give GamaSTAN S/D to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.(9)Do not give GamaSTAN S/D to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

Warnings

Administer GamaSTAN S/D cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.(9)GamaSTAN S/D is made from human plasma. Because GamaSTAN S/D is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for GamaSTAN S/D. ALL infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807].

General

Do not administer Immune Globulin (Human) subcutaneously or intravenously because of the potential for serious reactions (e.g., Renal Dysfunction/Failure/Hemolysis, Transfusion-Related Acute Lung Injury [TRALI]. Do not inject into a blood vessel.

Thrombosis

Thrombosis may occur following treatment with immune globulin products, including GamaSTAN S/D.(15-17) Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN S/D. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (see BOXED WARNING, PRECAUTIONS: Information for Patients, DOSAGE AND ADMINISTRATION)

Hypersensitivity

Do not perform skin tests. In most patients the intradermal injection of concentrated gamma globulin solution with its buffers causes a localized area of inflammation which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation of a chemical nature. Misinterpretation of the results of such tests can lead the physician to withhold beneficial human immunoglobulin from a patient who is not actually allergic to this material.Although true allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare, have epinephrine available for treatment of acute allergic symptoms, should they occur.

Information For Patients

ThrombosisInstruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.

Clinical And Laboratory Tests

None required.

Product Interactions

Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella and varicella for up to 6 months and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GamaSTAN S/D so that appropriate precautions can be taken.No interactions with other products are known.

Pregnancy

Animal reproduction studies have not been conducted with GamaSTAN S/D. It is also not known whether GamaSTAN S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. GamaSTAN S/D should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Adverse Reactions

Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations.(6,9) Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.

Dosage And Administration

  • FOR INTRAMUSCULAR ADMINISTRATION ONLY.DO NOT ADMINISTER SUBCUTANEOUSLY OR INTRAVENOUSLY.Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.Administer GamaSTAN S/D intramuscularly (see PRECAUTIONS), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. Do not use the gluteal region as an injection site because of the risk of injury to the sciatic nerve.(10) Doses over 10 mL should be divided and injected into several muscle sites to reduce local pain and discomfort. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered.Draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

How Supplied

GamaSTAN S/D is supplied in 2 mL and 10 mL single dose vials. GamaSTAN S/D is preservative-free and latex-free.  NDC Number                 Size13533-635-02        2 mL vial (10 pack)13533-635-04        2 mL vial13533-635-10       10 mL vial (10 pack)13533-635-12       10 mL vial

Storage

  • Store at 2–8°C (36–46°F).Do not freeze.Do not use after expiration date.

References

  • Smith GN, Griffiths B, Mollison D, et al: Uptake of IgG after intramuscular and subcutaneous injection. Lancet 1(7762): 1208-12, 1972.Waldmann TA, Strober W, Blaese RM: Variations in the metabolism of immunoglobulins measured by turnover rates. In Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses. Washington DC, Nat Acad Sci, 1970, pp 33-51.Recommendation of the Immunization Practices Advisory Committee (ACIP): Postexposure prophylaxis of hepatitis B. MMWR 33(21): 285-90, 1984.American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, p 231.Gershon AA, Piomelli S, Karpatkin M, et al: Antibody to varicella-zoster virus after passive immunization against chickenpox. J Clin Microbiol 8(6): 733-5, 1978.American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 134-5.Recommendation of the Public Health Service Advisory Committee on Immunization Practices: Measles prevention. MMWR 27(44): 427-30; 435-7, 1978.American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 34-6.Fudenberg HH: Sensitization to immunoglobulins and hazards of gamma globulin therapy. In: Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses. Washington DC, Nat Acad Sci, 1970, pp 211-20.Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP): General recommendations on immunization. MMWR 2002: 51(RR02), 1-36.Stenland CJ, Lee DC, Brown P, et al. Partitioning of human and sheep forms of the pathogenic prion protein during the purification of therapeutic proteins from human plasma. Transfusion 2002. 42(11):1497-500.Lee DC, Stenland CJ, Miller JL, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion 2001. 41(4):449-55.Lee DC, Stenland CJ, Hartwell RC, et al. Monitoring plasma processing steps with a sensitive Western blot assay for the detection of the prion protein. J Virol Methods 2000. 84(1):77-89.Cai K, Miller JL, Stenland CJ, et al. Solvent-dependent precipitation of prion protein. Biochim Biophys Acta 2002. 1597(1):28-35.Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-226.Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986;2:217-218.Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65,30-34.Zaaijer HL, Leentvaar-Kuijpers A, Rotman H, Lelie PN. Hepatitis A antibody titres after infection and immunization: implications for passive and active immunization. J Med Virol 40:22-27, 1993.Tejada-Strop A, Costafreda MI, Dimitrova Z, Kaplan G, Teo CG. Disparate potencies of immune globulin products against hepatitis A.FDA, 2016. In press.Revised 6/2017Grifols Therapeutics Inc.Research Triangle Park, NC 27709 USAU.S. License No. 18713045821

Package Label

Immune Globulin (Human)GamaSTAN® S/DSolvent/Detergent TreatedPreservative-free, latex-free10 mLOne Single Dose VialNDC 13533-635-12GRIFOLSThe patient and physician should discuss the risks and benefits of this product.FOR INTRAMUSCULAR INJECTION ONLY. DO NOT GIVE INTRAVENOUSLY.For complete dosage and administration information, read enclosed package insert.Store at 2-8°C (36-46°F).Do not freeze.If the shrink band is absent or shows any sign of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately.Not returnable for credit or exchange.Rx onlyCAUTION:  U.S. federal law prohibits dispensing without prescription.Immune Globulin (Human) is a sterile solution of immunoglobulin containing 15%–18% protein stabilized with 0.21–0.32 M glycine. The pH is adjusted with sodium carbonate.No U.S. standard of potency for viral hepatitis antibodies.Grifols Therapeutics Inc.Research Triangle Park,NC 27709 USAU.S. License No. 1871Carton: 08940717Immune Globulin(Human)GamaSTAN® S/D 10 mLSolvent/Detergent Treated Grifols Therapeutics Inc.Research Triangle Park, NC 27709 USAU.S. License No. 1871The patient and physician should discuss the risks and benefits of this product.  One Single Dose VialDo not give intravenously.Dosage:  Read Package insert.Rx onlyLot/Exp.                     3036920

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