Engerix-B (Hepatitis B Vaccine (Recombinant)) - Indications and Dosage

INDICATIONS AND USAGE

ENGERIX-B is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.

ENGERIX-B will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver.

Immunization is recommended in persons of all ages, especially those who are, or will be, at increased risk of exposure to hepatitis B virus, ¹ for example:

• Infants, Including Those Born of HBsAg-Positive Mothers (See DOSAGE AND ADMINISTRATION.)
• Adolescents (See CLINICAL PHARMACOLOGY.)
• Healthcare Personnel:   Dentists and oral surgeons. Dental, medical, and nursing students. Physicians, surgeons, and podiatrists. Nurses. Paramedical and ambulance personnel and custodial staff who may be exposed to the virus via blood or other patient specimens. Dental hygienists and dental nurses. Laboratory and blood bank personnel handling blood, blood products, and other patient specimens. Hospital cleaning staff who handle waste.
• Selected Patients and Patient Contacts:   Patients and staff in hemodialysis units and hematology/oncology units. Patients requiring frequent and/or large volume blood transfusions or clotting factor concentrates (e.g., persons with hemophilia, thalassemia, sickle cell anemia, cirrhosis). Clients (residents) and staff of institutions for the mentally handicapped. Classroom contacts of deinstitutionalized mentally handicapped persons who have persistent hepatitis B surface antigenemia and who show aggressive behavior. Household and other intimate contacts of persons with persistent hepatitis B surface antigenemia.
• Subpopulations With a Known High Incidence of the Disease, such as:   Alaskan Eskimos. Pacific Islanders. Indochinese immigrants. Haitian immigrants. Refugees from other HBV-endemic areas. All infants of women born in areas where the infection is highly endemic.
• Individuals With Chronic Hepatitis C:   Risk factors for hepatitis C are similar to those for hepatitis B. Consequently, immunization with hepatitis B vaccine is recommended for individuals with chronic hepatitis C.
• Persons Who May Be Exposed to the Hepatitis B Virus by Travel to High-Risk Areas (See ACIP Guidelines, 1990.)
• Military Personnel Identified as Being at Increased Risk
• Morticians and Embalmers
• Persons at Increased Risk of the Disease Due to Their Sexual Practices, ^{1, 16} such as: Persons with more than 1 sexual partner in a 6-month period. Persons who have contracted a sexually transmitted disease. Homosexually active males. Female prostitutes.
• Prisoners
• Users of Illicit Injectable Drugs
• Others:   Police and fire department personnel who render first aid or medical assistance, and any others who, through their work or personal life-style, may be exposed to the hepatitis B virus. Adoptees from countries of high HBV endemicity.

Use With Other Vaccines:    The ACIP states that, in general, simultaneous administration of certain live and inactivated pediatric vaccines has not resulted in impaired antibody responses or increased rates of adverse reactions. ¹⁷ Separate sites and syringes should be used for simultaneous administration of injectable vaccines.

DOSAGE AND ADMINISTRATION

Injection:    ENGERIX-B should be administered by intramuscular injection. Do not inject intravenously or intradermally. In adults, the injection should be given in the deltoid region but it may be preferable to inject in the anterolateral thigh in neonates and infants, who have smaller deltoid muscles. ENGERIX-B should not be administered in the gluteal region; such injections may result in suboptimal response. The attending physician should determine final selection of the injection site and needle size, depending upon the patient's age and the size of the target muscle. A 1-inch, 23-gauge needle is sufficient to penetrate the anterolateral thigh in infants younger than 12 months of age. A 5/8-inch, 25-gauge needle may be used to administer the vaccine in the deltoid region of toddlers and children up to, and including, 10 years of age. The 1-inch, 23-gauge needle is appropriate for use in older children and adults. ¹⁷

ENGERIX-B may be administered subcutaneously to persons at risk of hemorrhage (e.g., hemophiliacs). However, hepatitis B vaccines administered subcutaneously are known to result in lower GMTs. Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, subcutaneous administration should be used only in persons who are at risk of hemorrhage with intramuscular injections.

Preparation for Administration:    Shake well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration. With thorough agitation, ENGERIX-B is a slightly turbid white suspension. Discard if it appears otherwise. The vaccine should be used as supplied; no dilution is necessary. The full recommended dose of the vaccine should be used. Any vaccine remaining in a single-dose vial should be discarded.

Dosing Schedules:    The usual immunization regimen (see Table 1) consists of 3 doses of vaccine given according to the following schedule: first dose: at elected date; second dose: 1 month later; third dose: 6 months after first dose.

For hemodialysis patients, in whom vaccine-induced protection is less complete and may persist only as long as antibody levels remain above 10 mIU/mL, the need for booster doses should be assessed by annual antibody testing. 40 mcg (2 × 20 mcg) booster doses with ENGERIX-B should be given when antibody levels decline below 10 mIU/mL. ¹ Data show individuals given a booster with ENGERIX-B achieve high antibody titers. (See CLINICAL PHARMACOLOGY.)

There are alternate dosing and administration schedules which may be used for specific populations (see Table 2 and accompanying explanations).

Booster Vaccinations:    Whenever administration of a booster dose is appropriate, the dose of ENGERIX-B is 10 mcg for children 10 years of age and younger, 20 mcg for adolescents 11 through 19 years of age, and 20 mcg for adults. Studies have demonstrated a substantial increase in antibody titers after ENGERIX-B booster vaccination following an initial course with both plasma- and yeast-derived vaccines. (See CLINICAL PHARMACOLOGY.)

See previous section for discussion on booster vaccination for adult hemodialysis patients.

Known or Presumed Exposure to Hepatitis B Virus:    Unprotected individuals with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers, others experiencing percutaneous or permucosal exposure) should be given hepatitis B immune globulin (HBIG) in addition to ENGERIX-B in accordance with ACIP recommendations ¹ and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (see above).

STORAGE

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze ; discard if product has been frozen. Do not dilute to administer.

HOW SUPPLIED

ENGERIX-B is supplied as a slightly turbid white suspension in vials and prefilled TIP-LOK® syringes.

Adult Dose

20 mcg/mL in Single-Dose Vials in packages of 1 and 25 vials

NDC 58160-857-01 (package of 1)

NDC 58160-857-16 (package of 25)

20 mcg/mL in Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-857-46 (package of 5)

NDC 58160-857-50 (package of 25)

Pediatric/Adolescent Doses

10 mcg/0.5 mL in Single-Dose Vials in packages of 1 and 10 vials

NDC 58160-856-01 (package of 1)

NDC 58160-856-11 (package of 10)

10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

NDC 58160-856-46 (package of 5)

NDC 58160-856-50 (package of 25)

10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes with 1-inch 25-gauge SAFETYGLIDE™ needles

NDC 58160-856-56 (package of 25)

10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes with 1-inch 23-gauge SAFETYGLIDE needles

NDC 58160-856-58 (package of 25)

10 mcg/0.5 mL in Single-Dose Prefilled Disposable TIP-LOK Syringes with 5/8-inch 25-gauge SAFETYGLIDE needles

NDC 58160-856-57 (package of 25)

REFERENCES

1. Centers for Disease Control and Prevention. Hepatitis B. In: Atkinson W, Wolfe C, Humiston S, Nelson R, eds. Epidemiology and prevention of vaccine-preventable diseases. 6th ed. Atlanta, GA: Public Health Foundation; 2000:207-229.
2. Beasley RP, Hwang L-Y, Stevens CE, et al. Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of hepatitis B virus carrier state: Final report of a randomized double-blind, placebo-controlled trial. Hepatology 1983;3(2):135-141.
3. Centers for Disease Control and Prevention. New vaccine information materials for hepatitis B, haemophilus influenzae type B (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Federal Register February 23, 1999;64(35):9044-9045.
4. Chang M-H, Chen C-J, Lai M-S, et al. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. N Engl J Med 1997;336(26):1855-1859.
5. Lee M-S, Kim D-H, Kim H, et al. Hepatitis B vaccination and reduced risk of primary liver cancer among male adults: A cohort study in Korea. Int J Epidemiol 1998;27(2):316-319.
6. Centers for Disease Control and Prevention. Effectiveness of a Seventh Grade school entry vaccination requirement -- Statewide and Orange County, Florida, 1997-1998. MMWR 1998;47(34):711-715.
7. American Academy of Pediatrics. Universal hepatitis B immunization. Pediatrics 1992;89(4):795-800.
8. Centers for Disease Control and Prevention. Immunization of adolescents: Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. MMWR 1996;45(RR-13):1-16.
9. American Academy of Pediatrics. Immunization of adolescents: Recommendations of the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Medical Association. Pediatrics 1997;99(3):479-488.
10. André FE and Safary A. Clinical experience with a yeast-derived hepatitis B vaccine. In: Zuckerman AJ, ed. Viral hepatitis and liver disease. New York, NY: Alan R Liss, Inc.; 1988:1025-1030.
11. Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA 1989;261(22):3278-3281.
12. Stevens CE, Alter HJ, Taylor PE, et al. Hepatitis B vaccine in patients receiving hemodialysis. N Engl J Med 1984;311(8):496-501.
13. Hauser P, Voet P, Simoen E, et al. Immunological properties of recombinant HBsAg produced in yeast. Postgrad Med J 1987;63(Suppl 2):83-91.
14. Bush LM, Moonsammy GI, Boscia JA. Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another. Vaccine 1991;9(11):807-809.
15. Goilav C, Prinsen H, Safary A, et al. Immunization of homosexual men with a recombinant DNA vaccine against hepatitis B: Immunogenicity and protection. In: Zuckerman AJ, ed. Viral hepatitis and liver disease. New York, NY: Alan R Liss, Inc.; 1988:1057-1058.
16. Centers for Disease Control and Prevention. 1998 Guidelines for treatment of sexually transmitted diseases. MMWR 1998;47(RR-1):102.
17. Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994;43(RR-1):1-38.
18. Centers for Disease Control. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37 (13):197-200.
19. Public Health Service. National Vaccine Injury Compensation Program: Revision of the vaccine injury table. Federal Register February 8, 1995;60(26):7694.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, US License No. 1617

Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

ENGERIX-B and TIP-LOK are registered trademarks of GlaxoSmithKline

RECOMBIVAX HB is a registered trademark of Merck & Co.

SAFETYGLIDE is a trademark of Becton, Dickinson and Company.

©2003, GlaxoSmithKline. All rights reserved.

August 2003/EB:L34