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 not consider 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

Measles (Rubeola)

BayGam should be given in a dose of 0.11 mL/lb (0.2 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. ⁸

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.

STORAGE

Store at 2-8°C (36-48°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.

REFERENCES

1. Smith GN, Griffiths B, Mollison D, et al: Uptake of IgG after intramuscular and subcutaneous injection. Lancet 1(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.
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.
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.
10. Recommendations of the Immunization Practices Advisory Committee (ACIP): General reccomendations on immunization. MMWR 38(13): 205-14; 219-27, 1989.

Bayer Corporation
Pharmaceutical Division
Elkhart, IN 46515 USA

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