Immune Globulin (Human) — BayGam™ treated with solvent/detergent is a sterile solution of immune globulin for intramuscular administration; it contains no preservative. BayGam 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 diafiltra-tion. BayGam is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayGam 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 BayGam 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 Hepatitis B virus and the Herpes viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant 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 IIIand the filtration step in the processing of Effluent III to Filtrate III. Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.

Last updated on RxList: 11/13/2008

Hepatitis A

The prophylactic value of BayGam is greatest when given before or soon after exposure to hepatitis A. BayGam is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

Measles (Rubeola)

BayGam should be given to prevent or modify measles 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. BayGam 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 BayGam and measles vaccine should not be given at the same time.⁷ If a child is older than 12 months and has received BayGam, 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, BayGam should be given immediately.⁸ Children who are immunocompromised should not receive measles vaccine or any other live viral vaccine.

Varicella

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

Rubella

The routine use of BayGam for prophylaxis of rubella in early pregnancy is of dubious value and cannot be justified.⁶ Some studies suggest that the use of BayGam in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam may benefit those women who will notconsider a therapeutic abortion.⁴

Immunoglobulin Deficiency

In patients with immunoglobulin deficiencies, BayGam may prevent serious infection. However, BayGam 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, agammaglobulinemia associated with thymoma, and acquired agammaglobulinemia.

BayGam is administered intramuscularly (see PRECAUTIONS), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. The gluteal region should not be used routinely as an injection site because of the risk of injury to the sciatic nerve. 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. If the gluteal region is used when very large volumes are to be injected or multiple doses are necessary, the central region MUST be avoided; only the upper, outer quadrant should be used.¹⁰

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Hepatitis A

BayGam in a dose of 0.01 mL/lb (0.02 mL/kg) is recommended for household and institutional hepatitis A case contacts. The following doses of BayGam are recommended for persons who plan to travel in areas where hepatitis A is common.³

Length of Stay	Dose Volume
Less than 3 months	0.02 mL/kg
3 months or longer	0.06 mL/kg (repeat every 4–6 months)

Measles (Rubeola)

BayGam should be given 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 A susceptible child who is exposed to measles and who is immunocompromised should receive a dose of 0.5 mL/kg (maximum dose, 15 mL) of BayGam immediately.⁸

Varicella

If Varicella-Zoster Immune Globulin (Human) is unavailable, BayGam at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.⁵

Rubella

Some studies suggest that the use of BayGam in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, BayGam at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.⁴

Immunoglobulin Deficiency

BayGam may prevent serious infection in patients with immunoglobulin deficiencies if circulating IgG levels of approximately 200 mg/100 mL plasma are maintained. The recommended dosage is 0.66 mL/kg (at least 100 mg/kg) given every 3 to 4 weeks.⁶ A double dose is given at onset of therapy; some patients may require more frequent injections.

BayGam is supplied in 2 mL and 10 mL single dose vials.

NDC Number	Size
0026-0635-02	2 mL vial (10 pack)
0026-0635-04	2 mL vial
0026-0635-10	10 mL vial (10 pack)
0026-0635-12	10 mL vial

Storage

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

CAUTION

U.S. federal law prohibits dispensing without prescription.

LIMITED WARRANTY

A number of factors beyond our control 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.

No warranty, express or implied, including any warranty of merchantability or fitness is made. Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert for this product, except by printed notice from the Company's headquarters. The prescriber and user of this product must accept the terms hereof.

REFERENCE

4. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, p 231.

5. Gershon AA, Piomelli S, Karpatkin M, et al: Antibody to varicella-zoster virus after passive immunization against chicken-pox. J Clin Microbiol 8(6): 733-5, 1978.

6. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 134-5.

7. Recommendation of the Public Health Service Advisory Committee on Immunization Practices: Measles prevention. MMWR 27(44): 427-30; 435-7, 1978.

8. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 34-6.

10. Recommendations of the Immunization Practices Advisory Committee (ACIP): General recommendations on immunization. MMWR 38(13): 205-14: 219-27, 1989.

Bayer Corporation, Pharmaceutical Division Elkhart, IN 46515 USA. Rev. April 1998. FDA revision date: n/a

Last updated on RxList: 11/13/2008

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 BayGam is given intravenously; therefore, BayGam must be administered only intramuscularly.

Clinically Significant Product Interactions

Antibodies in the globulin preparation may interfere with the response to live viral vaccines such as measles, mumps, polio and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Immune Globulin (Human) — BayGam™ administration.

No interactions with other products are known.

REFERENCE

6. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 134-5.

9. 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.

Last updated on RxList: 11/13/2008

BayGam is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-888-765-3203].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

BayGam should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.⁹

General

Immune Globulin (Human) should not be administered intravenously because of the potential for serious reactions. Injections should be made intramuscularly, and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.

Skin tests should not be done. In most human beings 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 badly needed human immunoglobulin from a patient who is not actually allergic to this material. True allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare.

Although systemic reactions to intramuscularly administered immunoglobulin preparations are rare, epinephrine should be available for treatment of acute allergic symptoms.

Clinical and Laboratory Tests

None required.

Pregnancy Category C

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

Pediatric Use

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

REFERENCE

9. 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.

Last updated on RxList: 11/13/2008

No information provided.

BayGam should not be given 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 BayGam should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

REFERENCE

9. 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.

Last updated on RxList: 11/13/2008

Peak levels of immunoglobulin G are obtained approximately 2 days after intramuscular injection of BayGam.¹ The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.²

Passive immunization with BayGam modifies hepatitis A, prevents or modifies measles, and provides replacement therapy in persons with hypogammaglobulinemia or agammaglobulinemia. BayGam 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

BayGam 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 BayGam 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 vari-cella. 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), BayRab™, 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.

REFERENCE

1. Smith GN, Griffiths B, Mollison D, et al: Uptake of IgG after intramuscular and subcutaneous injection. Lancet1(7762): 1208-12, 1972.

2. 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.

3. Recommendation of the Immunization Practices Advisory Committee (ACIP): Postexposure prophylaxis of hepatitis B. MMWR 33(21): 285-90, 1984.

4. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, p 231.

5. Gershon AA, Piomelli S, Karpatkin M, et al: Antibody to varicella-zoster virus after passive immunization against chicken-pox. J Clin Microbiol 8(6): 733-5, 1978.

6. American Academy of Pediatrics, Committee on Infectious Diseases: Report. ed. 19. Evanston, 1982, pp 134-5.

Last updated on RxList: 11/13/2008

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 11/13/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

IMMUNE GLOBULIN - INTRAMUSCULAR

(ih-MYOON GLOB-you-lin)

COMMON BRAND NAME(S): Gamastan, Gammar

USES: 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.

HOW TO USE: This medication is injected into a muscle by a health care professional. Do not inject this medication into a vein or under the skin.

Follow all instructions for preparation and use. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Do not shake the medication. If you have questions about the use of this medication, consult your pharmacist.

The dosage and schedule of injections depends on your medical condition, weight, and response to treatment. Large doses (more than 10 milliliters) should be divided into 2 or more injections and given at separate injection sites.

This medication is given as soon as possible after you have had contact with (been exposed to) someone with hepatitis A, measles, chicken pox, or rubella. If you wait too long after being exposed, the medication may not be effective. Not everyone who is exposed to these infections should receive immunoglobulin. Discuss the risks and benefits with your doctor.

If you are traveling to an area where hepatitis A is common, this medication may be given along with the hepatitis A vaccine (in a separate injection). This medication will help protect you until your body can make antibodies from the vaccine. If you cannot use the hepatitis A vaccine, you may need to receive more doses of immune globulin if you are staying in the area for a long time (more than 3 months). Do not receive live virus vaccines (e.g., measles) at the same time as immune globulin. (See also Precautions section.) Ask your doctor or pharmacist for more details and a recommended vaccination schedule.

If you are using this medication for an immune system problem, it is usually given every 3 to 4 weeks or as directed by your doctor. Use this medication regularly in order to get the most benefit from it. Keep all your medical/lab appointments.

SIDE EFFECTS: Muscle stiffness, redness, warmth, pain, and tenderness at the injection site may occur. Fever, chills, headache, and joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, change in the amount of urine, pink/bloody/frothy urine, sudden weight gain.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., IVIG); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (immunoglobulin A deficiency), bleeding/blood clotting problems (e.g., low platelets, hemophilia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Tell your doctor of any recent/planned vaccinations. This medication may prevent a good response to live virus vaccines (e.g., measles, mumps, rubella). If you are vaccinated less than 14 days before receiving this medication or during the 6 months after receiving this medication, you may need to be vaccinated again or tested to see whether the vaccine was effective.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may harm the kidneys (e.g., aminoglycosides such as gentamicin).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (e.g., kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: Because this medication provides protection for only a limited time (1 to 3 months), additional doses may be necessary based on the situation. Discuss this with your doctor.

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.