Data from FDA - Curated by Toby Galbraith - Last updated 18 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Visit Transplantation

Psoriasis

See information on psoriasis pathophysiology, signs and symptoms, comorbidities, treatment options, and more

Visit Psoriasis

Advisory information

contraindications
CONTRAINDICATIONS Hypersensitivity to any component of the vaccine, including yeast, is a contraindication (see DESCRIPTION). This vaccine is contraindicated in patients with previous hypersensitivity to any hepatitis B-containing vaccine.
Special warnings and precautions

PRECAUTIONS General: As with other vaccines, although a moderate or severe febrile illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.17 Prior to immunization, the patient 's medical history should be reviewed.

The physician should review the patient 's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions, and occurrence of any adverse event-related symptoms and/or signs in order to determine the existence of any contraindication to immunization with ENGERIX-B and to allow an assessment of benefits and risks.

Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another.

Needles should be disposed of properly and should not be recapped.

Special care should be taken to prevent injection into a blood vessel.

As with any vaccine administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

For individuals receiving immunosuppressive therapy, deferral of vaccination for at least 3 months after therapy may be considered.17 The potential risk of apnea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunization series to very premature infants (born?28 weeks of gestation) who remain hospitalized at the time of vaccination and particularly for those with a previous history of respiratory immaturity.

It is generally understood that the benefit of vaccination is high in very premature infants.

The decision to vaccinate should be based on careful consideration of the potential benefits and possible risks.

Multiple Sclerosis: Although no causal relationship has been established, rare instances of exacerbation of multiple sclerosis have been reported following administration of hepatitis B vaccines and other vaccines.

In persons with multiple sclerosis, the benefit of immunization for prevention of hepatitis B infection and sequelae must be weighed against the risk of exacerbation of the disease.

Information for the Patient: Patients, parents, or guardians should be informed of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series.

As with any vaccine, it is important when a subject returns for the next dose in a series that he or she be questioned concerning occurrence of any symptoms and/or signs of an adverse reaction after a previous dose of the same vaccine.

Patients, parents, or guardians should be told to report severe or unusual adverse reactions to their healthcare provider.

The parent or guardian should be given the Vaccine Information Materials, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization.

Drug Interactions: For information regarding simultaneous administration with other vaccines, refer to INDICATIONS AND USAGE. Carcinogenesis, Mutagenesis, Impairment of Fertility: ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with ENGERIX-B.

It is also not known whether ENGERIX-B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

ENGERIX-B should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether ENGERIX-B is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when ENGERIX-B is administered to a nursing woman.

Pediatric Use: ENGERIX-B has been shown to be well tolerated and highly immunogenic in infants and children of all ages.

Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine.

(See CLINICAL PHARMACOLOGY for seroconversion rates and titers in neonates and children.

See DOSAGE AND ADMINISTRATION for recommended pediatric dosage and for recommended dosage for infants born of HBsAg-positive mothers.)

Geriatric Use: Clinical studies of ENGERIX-B did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects.

Other reports from the clinical literature indicate that hepatitis B vaccines are less immunogenic in adults 65 years of age and older than in younger individuals.

Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.

Adverse reactions

ADVERSE REACTIONS ENGERIX-B is generally well tolerated.

As with any vaccine, however, it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.

Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines.

In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates.

All subjects were monitored for 4 days post-administration.

Frequency of adverse experiences tended to decrease with successive doses of ENGERIX-B.

Using a symptom checklist,† the most frequently reported adverse reactions were injection site soreness (22 %) and fatigue† (14 %).

Other reactions are listed below.

Incidence 1 % to 10 % of Injections: Nervous System Disorders: Dizziness†, headache.† General Disorders and

Administration Site

Conditions: Fever (>37.5°C), injection site erythema, injection site induration, injection site swelling.

†Parent or guardian completed forms for children and neonates.

Neonatal checklist did not include headache, fatigue, or dizziness.

Incidence <1 % of Injections: Infections and Infestations: Upper respiratory tract illnesses.

Blood and Lymphatic System Disorders: Lymphadenopathy.

Metabolism and Nutrition Disorders: Anorexia.

Psychiatric Disorders: Agitation, insomnia.

Nervous System Disorders: Somnolence, tingling.

Vascular Disorders: Flushing, hypotension.

Gastrointestinal Disorders: Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting.

Skin and Subcutaneous Tissue Disorders: Erythema, petechiae, pruritus, rash, sweating, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck.

General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness.

Postmarketing Reports: Additional adverse experiences have been reported with the commercial use of ENGERIX-B.

Those listed below are to serve as alerting information to physicians.

Infections and Infestations: Herpes zoster, meningitis.

Blood and Lymphatic System Disorders: Thrombocytopenia.

Immune System Disorders: Allergic reaction, anaphylactoid reaction, anaphylaxis.

An apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum (see CONTRAINDICATIONS).

Nervous System Disorders: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, paresthesia, Guillain-Barr?

syndrome and Bell 's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis.

Eye Disorders: Conjunctivitis, keratitis, visual disturbances.

Ear and Labyrinth Disorders: Earache, tinnitus, vertigo.

Cardiac Disorders: Palpitations, tachycardia.

Vascular Disorders: Vasculitis.

Respiratory, Thoracic and Mediastinal Disorders: Apnea, bronchospasm including asthma-like symptoms.

Gastrointestinal Disorders: Dyspepsia.

Skin and Subcutaneous Tissue Disorders: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura.

Musculoskeletal and Connective Tissue Disorders: Arthritis, muscular weakness.

General Disorders and Administration Site Conditions: Injection site reaction.

Investigations: Abnormal liver function tests.

Reporting Adverse Events: The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare provider in the vaccine recipient 's permanent medical record, along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine.18 The Act further requires the healthcare provider to report to the US Department of Health and Human Services via VAERS the occurrence following immunization of any event set forth in the Vaccine Injury Table including: Anaphylaxis or anaphylactic shock within 4 hours, encephalopathy or encephalitis within 72 hours, or any sequelae thereof (including death).

18,19 In addition, any event considered a contraindication to further doses should be reported.

The VAERS toll-free number is 1-800-822-7967.

Usage information

Dosing and administration

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.

Inspect ENGERIX-B visually for particulate matter, discoloration and cracks in the vial or syringe prior to administration, whenever solution and container permit.

If any of these conditions exist, the vaccine should not be administered.

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.

Table 1.

Recommended Dosage and Administration Schedules Group Dose Schedules Infants born of: HBsAg-negative mothers 10 mcg/0.5 mL 0, 1, 6 months HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 6 months Children: Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 6 months Adolescents: 11 through 19 years of age 10 mcg/0.5 mL 0, 1, 6 months Adults (>19 years) 20 mcg/1.0 mL 0, 1, 6 months Adult hemodialysis 40 mcg/2.0 mLa 0, 1, 2, 6 months aTwo?

20 mcg in 1 or 2 injections.

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).

Table 2.

Alternate Dosage and Administration Schedules Group Dose Schedules Infants born of: HBsAg-positive mothers 10 mcg/0.5 mL 0, 1, 2, 12 monthsa Children: Birth through 10 years of age 10 mcg/0.5 mL 0, 1, 2, 12 monthsa 5 through 10 years of age 10 mcg/0.5 mL 0, 12, 24 monthsb Adolescents: 11 through 16 years of age 10 mcg/0.5 mL 0, 12, 24 monthsb 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 6 months 11 through 19 years of age 20 mcg/1.0 mL 0, 1, 2, 12 monthsa Adults (>19 years) 20 mcg/1.0 mL 0, 1, 2, 12 monthsa aThis schedule is designed for certain populations (e.g., neonates born of hepatitis

B-infected mothers, others who have or might have been recently exposed to the virus, certain travelers to high-risk areas.

See INDICATIONS AND USAGE).

On this alternate schedule, an additional dose at 12 months is recommended for prolonged maintenance of protective titers.

bFor children and adolescents for whom an extended administration schedule is acceptable based on risk of exposure.

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 recommendations1 and with the package insert for HBIG. ENGERIX-B can be given on either dosing schedule (see above).

Pregnancy and lactation
Nursing Mothers: It is not known whether ENGERIX-B is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ENGERIX-B is administered to a nursing woman.

More information

Category Value
Authorisation number BLA103239
Orphan designation No
Product NDC 68258-3042
Date Last Revised 02-03-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 1658157
Storage and handling 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.
Marketing authorisation holder Dispensing Solutions Inc.

Related Content