DOSAGE AND ADMINISTRATION
BayGam (immune globulin) 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
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container permit.
BayGam (immune globulin) 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 (immune globulin) are recommended
for persons who plan to travel in areas where hepatitis A is common.3
|Length of Stay
|Less than 3 months
|3 months or longer
||0.06 mL/kg (repeat every 4–6 months)
BayGam (immune globulin) 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 (immune globulin) immediately.8
If Varicella-Zoster Immune Globulin (Human) is unavailable, BayGam (immune globulin) at a dose
of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.5
Some studies suggest that the use of BayGam (immune globulin) in exposed, susceptible women can
lessen the likelihood of infection and fetal damage; therefore, BayGam (immune globulin) at a
dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.4
BayGam (immune globulin) 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 (immune globulin) is supplied in 2 mL and 10 mL single dose vials.
||2 mL vial (10 pack)
||2 mL vial
||10 mL vial (10 pack)
||10 mL vial
Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration
U.S. federal law prohibits dispensing without prescription.
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.
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):
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,
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:
Bayer Corporation, Pharmaceutical Division Elkhart, IN
46515 USA. Rev. April 1998. FDA revision date: n/a