Engerix-b

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Engerix-b Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hepatitis B vaccine (recombinant) 10mcg/0.5mL, 20mcg/mL; susp; aluminum hydroxide adsorbed; IM inj; preservative-free.

    Pharmacological Class

    HB.

    How Supplied

    Single-dose prefilled Tip-Lok syringes (Pediatric/Adolescent dose)—1, 10 (without needles); Single-dose prefilled Tip-Lok syringes (Adult dose)—1, 10 (without needles); Single-dose vials (Adult dose)—1, 10

    Storage

    Store refrigerated between 2° and 8° C (36° and 46° F). 

    Do not freeze; discard if the product has been frozen. Do not dilute to administer.

    Manufacturer

    GlaxoSmithKline

    Generic Availability

    NO

    Mechanism of Action

    Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Antibody concentrations ≥10mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.

    Engerix-b Indications

    Indications

    Hepatitis B immunization.

    Engerix-b Dosage and Administration

    Adult

    Give IM in deltoid muscle. 11–19yrs: 10mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later, or 20mcg at elected date and repeat 1 and 6 months later. ≥20yrs: 20mcg at elected date and repeat 1 and 6 months later, or 20mcg at elected date and repeat 1, 2, and 12 months later. Hemodialysis: 40mcg at elected date and repeat 1, 2, and 6 months later. High-risk or known/presumed exposure: consider hepatitis B immune globulin also. Booster dose: when appropriate, may use 20mcg for persons 11yrs of age and older; hemodialysis patients booster dose is 40mcg.

    Children

    Give IM in anterolateral thigh or deltoid; see full labeling. Infants (mothers are HBsAG negative): 10mcg at birth and repeat 1 and 6 months later; infants (mothers are HBsAG positive) and children through age 10yrs: 10mcg at elected date and repeat 1 and 6 months later, or 10mcg at elected date and repeat 1, 2, and 12 months later. High risk or known/presumed exposure: consider hepatitis B immune globulin also. Booster doses: when appropriate, may use 10mcg for children age 10yrs or younger, or 20mcg for ages 11yrs and older.

    Administration

    Administer Engerix-B by intramuscular injection. The preferred administration site is the anterolateral aspect of the thigh for infants younger than 1 year and the deltoid muscle in older children and adults. Do not administer Engerix-B in the gluteal region; may result in suboptimal response.

    Engerix-B may be given subcutaneously to persons at risk of hemorrhage (eg, hemophiliacs). However, hepatitis B vaccines given subcutaneously are known to result in a lower antibody response. 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.

    Do not administer this product intravenously or intradermally.

    Engerix-b Contraindications

    Contraindications

    Yeast hypersensitivity.

    Engerix-b Boxed Warnings

    Not Applicable

    Engerix-b Warnings/Precautions

    Warnings/Precautions

    May defer in acute febrile illness or active infection. May be given SC only if risk of hemorrhage. Have epinephrine inj available. Immunocompromised. Latex allergy (prefilled syringes). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Syncope

    • Syncope can occur with administration of injectable vaccines, including Engerix-B.
    • Syncope can be accompanied by transient neurological signs (eg, visual disturbance, paresthesia, tonic-clonic limb movements).
    • Have procedures in place to avoid falling injury and to restore cerebral perfusion following syncope.

    Infants Weighing <2,000 g at Birth

    • Defer Hepatitis B vaccine for infants with a birth weight <2,000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Vaccination can commence at chronological age 1 month or hospital discharge.
    • Infants born weighing <2,000 g to HBsAg-positive mothers should receive vaccine and HBIG within 12 hours after birth.
    • Infants born weighing <2,000 g to mothers of unknown HBsAg status should receive vaccine and HBIG within 12 hours after birth if the mother’s HBsAg status cannot be determined within the first 12 hours of life.
    • The birth dose in infants born weighing <2,000 g should not be counted as the first dose in the vaccine series; it should be followed with a full 3-dose standard regimen (total of 4 doses).

    Apnea in Premature Infants

    • Apnea following intramuscular vaccination has been seen in some infants born prematurely.
    • Consider the infant’s medical status, and the potential benefits and possible risks of vaccination in making decisions about when to give an intramuscular vaccine to infants born prematurely. For Engerix-B, this assessment should include consideration of the mother’s hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born of mothers who are HBsAg positive if vaccination is delayed.

    Preventing and Managing Allergic Vaccine Reactions

    • Review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks prior to immunization.
    • Have epinephrine and other appropriate agents used for the control of immediate allergic reactions immediately available should an acute anaphylactic reaction occur. 

    Moderate or Severe Acute Illness

    • Postpone vaccination in persons with moderate or severe acute febrile illness, unless they are at immediate risk of hepatitis B infection (eg, infants born of HBsAg-positive mothers) to avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects.

    Pregnancy Considerations

    There are no adequate and well-controlled studies of Engerix-B in pregnant women in the US. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received Engerix-B during pregnancy.

    Nursing Mother Considerations

    There is no information regarding the presence of Engerix-B in human milk, the effects on the breastfed child, or the effects on milk production. Consider the benefits of breastfeeding along with the mother’s need for Engerix-B and any potential adverse effects on the breastfed child.

    Pediatric Considerations

    The timing of the first dose in infants weighing <2,000 g at birth depends on the HBsAg status of the mother.

    Geriatric Considerations

    Clinical studies of Engerix-B did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Later studies has shown that a diminished antibody response and seroprotective levels can be expected in persons >60 years.

    Engerix-b Pharmacokinetics

    See Literature

    Engerix-b Interactions

    Not Applicable

    Engerix-b Adverse Reactions

    Adverse Reactions

    Injection site reactions (eg, soreness, erythema, induration, swelling), fatigue, dizziness, headache; syncope, anaphylaxis.

    Engerix-b Clinical Trials

    Clinical Trials

    Efficacy in Neonates

    • Protective efficacy with Engerix-B was demonstrated in a clinical trial in neonates at high risk of hepatitis B infection.
    • Fifty-eight neonates born of mothers who were both HBsAg-positive and hepatitis B “e” antigen (HBeAg)-positive were given Engerix-B (10 mcg/0.5 mL) at 0, 1, and 2 months, without concomitant hepatitis B immune globulin (HBIG).
    • Two infants became chronic carriers in the 12-month follow-up period after initial inoculation. Assuming an expected carrier rate of 70%, the protective efficacy rate against the chronic carrier state during the first 12 months of life was 95%.

    Immunogenicity in Neonates

    • In clinical studies, neonates were given Engerix-B (10 mcg/0.5 mL) at age 0, 1, and 6 months or at age 0, 1, and 2 months. The immune response to vaccination was evaluated in sera obtained 1 month after the third dose of Engerix-B.
    • Among infants given Engerix-B at age 0, 1, and 6 months, 100% of evaluable subjects (n=52) seroconverted by Month 7. The geometric mean antibody titer (GMT) was 713 mIU/mL. Of these, 97% had seroprotective levels (≥10 mIU/mL).
    • Among infants enrolled (n=381) to receive Engerix-B at age 0, 1, and 2 months, 96% had seroprotective levels (≥10 mIU/mL) by Month 4. The GMT among seroconverters (n=311) (antibody titer ≥1 mIU/mL) was 210 mIU/mL. A subset of these children received a fourth dose of Engerix-B at age 12 months. One month following this dose, seroconverters (n=126) had a GMT of 2941 mIU/mL.

    Immunogenicity in Children and Adults

    Persons Aged 6 Months through 10 Years

    • In clinical trials, children (N=242) aged 6 months through 10 years were given Engerix-B (10 mcg/0.5 mL) at 0, 1, and 6 months. One to 2 months after the third dose, the seroprotection rate was 98% and the GMT of seroconverters was 4023 mIU/mL.

    Persons Aged 5 through 16 Years

    • In a separate clinical trial including both children and adolescents aged 5 through 16 years, Engerix-B (10 mcg/0.5 mL) was administered at 0, 1, and 6 months (n=181) or 0, 12, and 24 months (n=161). Immediately before the third dose of vaccine, seroprotection was achieved in 92.3% of patients vaccinated on the 0-, 1-, and 6-month schedule and 88.8% of patients on the 0-, 12-, and 24-month schedule (GMT: 118 mIU/mL vs 162 mIU/mL, respectively, P =0.18). One month following the third dose, seroprotection was achieved in 99.5% of children vaccinated on the 0-, 1-, and 6-month schedule compared with 98.1% of those on the 0-, 12-, and 24-month schedule. GMTs were higher (P =0.02) for children receiving vaccine on the 0-, 1-, and 6-month schedule compared with those on the 0-, 12-, and 24-month schedule (5687 mIU/mL vs 3159 mIU/mL, respectively).

    Persons Aged 11 through 19 Years

    • In clinical trials with healthy adolescent patients (aged 11 through 19 years), Engerix-B (10 mcg/0.5 mL) given at 0, 1, and 6 months produced a seroprotection rate of 97% at Month 8 (n=119) with a GMT of 1989 mIU/mL (n=118; 95% CI, 1318-3020). Immunization with Engerix-B (20 mcg/1 mL) at 0, 1, and 6 months produced a seroprotection rate of 99% at Month 8 (n=122) with a GMT of 7672 mIU/mL (n=122; 95% CI, 5248-10965).

    Persons Aged 16 through 65 Years

    • Clinical trials in healthy adult and adolescent patients (aged 16 through 65 years) have shown that following a course of 3 doses of Engerix-B (20 mcg/1 mL) given at 0, 1, and 6 months, the seroprotection (antibody titers ≥10 mIU/mL) rate for all individuals was 79% at Month 6 (5 months after second dose) and 96% at Month 7 (1 month after third dose); the GMT for seroconverters was 2204 mIU/mL at Month 7 (n=110).
    • An alternate 3-dose schedule (20 mcg/1 mL given at 0, 1, and 2 months) designed for certain populations (eg, individuals who have or might have been recently exposed to the virus and travelers to high-risk areas) was also evaluated. At Month 3 (1 month after third dose), 99% of all individuals were seroprotected and remained protected through Month 12. On the alternate schedule, a fourth dose of Engerix-B (20 mcg/1 mL) at 12 months produced a GMT of 9163 mIU/mL at Month 13 (1 month after fourth dose) (n=373).

    Persons Aged 40 Years and Older

    • Among patients aged 40 years and older given Engerix-B (20 mcg/1 mL) at 0, 1, and 6 months, the seroprotection rate 1 month after the third dose was 88% and the GMT for seroconverters was 610 mIU/mL (n=50). In adults aged older than 40 years, Engerix-B produced anti-HBsAg antibody titers that were lower than those in younger adults.

    Engerix-b Note

    Not Applicable

    Engerix-b Patient Counseling

    Patient Counseling

    Inform vaccine recipients and parents or guardians:

    • The potential benefits and risks of immunization with Engerix-B.
    • Emphasize the potential side effects, that Engerix-B contains non-infectious purified HBsAg and cannot cause hepatitis B infection.
    • Instruct to report any adverse events to their healthcare provider.

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