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7. DRUG INTERACTIONS Distributed by: Manufactured by:
™
7.1 Live Attenuated Virus Vaccines Apotex Corp Cangene Corporation
HepaGam B
Immune globulin administration may impair the efficacy of Weston, FL 33326 Winnipeg, Canada R3T 5Y3
live attenuated virus vaccines such as measles, rubella,
(Hepatitis B Immune Globulin
mumps and varicella.
4,6,7
Vaccination with live virus
R only
χ
vaccines should be deferred until approximately three
Intravenous [Human])
months after administration of HepaGam B, Hepatitis B
U.S. License No. 1201 USA
Immune Globulin Intravenous (Human). Persons who
BRIEF SUMMARY OF PRESCRIBING
April 2007 APOCAN-025-01
received HepaGam B less than 14 days after live virus
INFORMATION FOR THE PREVENTION OF vaccination should be revaccinated 3 months after the REFERENCES:
HBV RECURRENCE FOLLOWING LIVER
administration of the immune globulin,unless serologic
1. Terrault NA, Zhou S, Combs C, Hahn JA, Lake JR,
test results indicate that antibodies were produced.
6,7
Roberts JP et al. Prophylaxis in liver transplant
TRANSPLANT
recipients using a fixed dosing schedule of
Continued from previous page.
There are no available data on drug interactions of
hepatitis B immunoglobulin. Hepatology 1996;
(Please see full prescribing information
HepaGam B with other medications.
24(6):1327-33.
for other indicated uses)
7.3 Drug-Laboratory Interactions: Blood Glucose Testing
2. McGory RW, Ishitani MB, Oliveira WM, Stevenson
HepaGam B contains maltose which can interfere with
WC, McCullough CS, Dickson RC et al. Improved
Adverse Event Number of AEs
certain types of blood glucose monitoring systems. [See
outcome of orthotopic liver transplantation for
by system organ class (in number of patients) N=14 Warnings and Precautions (5.3).] Only testing systems that chronic hepatitis B cirrhosis with aggressive
Metabolism and nutrition disorders
are glucose-specific should be used in patients receiving
passive immunization. Transplantation 1996;
- Hyperglycaemia 4 (4) HepaGam B. This interference can result in falsely elevated
61(9):1358-1364.
Musculoskeletal glucose readings that can lead to untreated hypoglycemia
- Back pain 2 (2) or to inappropriate insulin administration, resulting in life-
3. Samuel D, Muller R, Alexander G, Fassati L,
Nervous system disorders threatening hypoglycemia.
Ducot B, Benhamou JP et al. Liver transplantation
- Amnesia 2 (2)
in European patients with the hepatitis B surface
- Essential Tremor 6 (2)
8. USE IN SPECIFIC POPULATIONS
antigen. N Engl J Med 1993; 329(25):1842-1847.
- Headache 15 (9)
8.1 Pregnancy Category C
Psychiatric disorders
Animal reproduction studies have not been conducted with
- Agitation 2 (2)
4. Committee for Proprietary Medicinal Products
HepaGam B. It is also not known whether HepaGam B can
Renal and urinary disorders
(CPMP). Core SPC for human plasma derived
- Nocturia 2 (2)
cause fetal harm when administered to a pregnant woman
hepatitis-B immunoglobulin for intravenous use
or can affect reproductive capacity. HepaGam B should be
Respiratory, thoracic and mediastinal
(CPMP/BPWG/4027/02). London, UK: The
- Pleural effusion 3 (3)
given to a pregnant woman only if clearly indicated.
European Agency for the Evaluation of Medicinal
Skin and subcutaneous tissue disorders
Products. 2003.
- Pruritus 3 (3)
8.2 Nursing Mothers
- Rash 2 (2)
It is not known whether HepaGam B is excreted in human
5. Unpublished data on file.
Vascular disorders
milk. Because many drugs are excreted in human milk,
- Hypertension 8 (7)
caution should be exercised when HepaGam B is
6. CDC. A comprehensive immunization strategy to
- Hypotension 2 (2) administered to a nursing mother.
eliminate transmission of hepatitis B virus infection
in the United States. Recommendations of the
Healthy Volunteer Studies 10. OVERDOSAGE
Advisory Committee on Immunization Practices
Seventy healthy male and female volunteers received a Consequences of an overdose are not known. Although no
(ACIP). Part 1: Immunization of infants, children,
single dose of HepaGam B intramuscularly in clinical data are available, clinical experience reported with other
and adolescents. MMWR 2005; 54(RR-16): 1-32.
trials.
6
Seventeen (17) subjects reported 30 adverse events intravenously administered human immune globulin
following administration of HepaGam B. The most frequently preparations suggests that doses above 1 g immune
7. CDC. A comprehensive immunization strategy
reported adverse events included 4 subjects (6%) who globulin/kg body weight are tolerated.
to eliminate transmission of hepatitis B virus
experienced headache, 7 subjects (10%) who had cold
infection in the United States. Recommendations
symptoms or flu and 2 subjects (3%) who experienced 16. HOW SUPPLIED/STORAGE AND HANDLING
of the Advisory Committee on Immunization
lightheadeness/fainted. The majority of events were NDC 60492-0052-1; a carton containing a 1.0 mL single
Practices (ACIP). Part 2: Immunization of adults.
reported as mild and were not related to study drug. One dose vial (>312 IU/mL; measured potency of each lot is
MMWR 2006; 55(RR-16): 1-33.
adverse event, an episode of nausea, was considered to stamped on the vial label) and a package insert.
be drug related. There were no serious adverse events re- NDC 60492-0051-1; a carton containing a 5.0 mL single
ported. A similar number of subjects in the comparator dose vial (>312 IU/mL; measured potency of each lot is
groups reported adverse events. stamped on the vial label) and a package insert.
6.3 Postmarketing Experience Store at 36 to 46 °F (2 to 8 °C). Do not freeze. Do not use
As of April 2007, there have been no postmarketing adverse after expiration date. Use within 6 hours after the vial has
events reported for HepaGam B administered i.m. been entered.
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