Engerix
Indications and Usage
ENGERIX-B is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.
Dosage and Administration
- ENGERIX-B is administered by intramuscular injection.
- Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, 6-month schedule.
- Persons 20 years of age and older: A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
Adults on hemodialysis: A series of 4 doses (2 mL each) given as a single 2-mL dose or as two 1-mL doses on a 0-, 1-, 2-, 6-month schedule.
Dosage Forms and Strengths
ENGERIX-B is a sterile suspension available in the following presentations:
1. 0.5-mL (10 mcg) single-dose vials and prefilled syringes (3)
2. 1-mL (20 mcg) single-dose vials and prefilled syringes (3)
Contraindications
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of ENGERIX-B, including yeast.
Warnings and Precaution
- ENGERIX-B is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. Use of these syringes may cause allergic reactions in latex-sensitive individuals.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including ENGERIX-B. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including ENGERIX-B, to infants born prematurely should be based on consideration of the infant’s medical status, and the potential benefits and possible risks of vaccination.
Adverse Reactions
The most common solicited adverse events were injection-site soreness (22%) and fatigue (14%).
Use in Specific Populations
1. Safety has not been established in pregnant women. ENGERIX-B should only be given to a pregnant woman if clearly needed.
2. Antibody responses are lower in persons older than 60 years of age than in younger adults.
Engerix™-B
Manufacturer: GlaxoSmithKline
Distributor: Zuellig
Contents: Hepatitis (rDNA) B vaccine (adsorbed)
Indications / Uses: Active immunization against HBV infection caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV.
Dosage / Direction for Use
Intramuscular; Adult ≥20 yr 20 mcg dose. Neonate, infant & childn ≤19 yr 10 mcg dose.
Primary immunization 3 doses at 0, 1 & 6 month gives optimal protection at month 7 or an accelerated schedule at 0, 1 & 2 month administered w/ a 4th dose at 12 month.
Patient ≥20 yr Rapid immunization 3 doses at 0, 7 & 21 days administered w/ a 4th dose 12 month after 1st dose. Patient 11-15 yr w/ low risk of hepatitis B infection 20 mcg at 0 & 6 month. Patient w/ renal insufficiency & those undergoing hemodialysis ≥16 yr 2 x 20 mcg at 1, 2 & 6 month after 1st dose; ≤15 yr including neonate 10 mcg at 0, 1, 2 & 12 month or 0, 1 & 6 month.
Known or presumed exposure to HBV Administer 1st dose w/ HBIg (separate inj site) at 0, 1, 2 & 12 month. Neonate born of HBV-carrier mothers 10 mcg starting at birth following either the 0, 1, 2 & 12 month or 0, 1 & 6 month schedule.
Contraindications: Hypersensitivity. Do not administer intravascularly.
Special Precautions: Postpone vaccination in patients w/ acute severe febrile illness. Possible infection. Consider additional doses in adults >40 yr; patients undergoing hemodialysis, HIV-infected patients, impaired immunity. Should be administered subcutaneously in patients w/ thrombocytopenia or bleeding disorders. Do not administer intradermally or in the buttock. Consider respiratory monitoring for 48-72 hr in very premature infants (born ≤28 wk of gestation) particularly those w/ history of respiratory immaturity. Pregnancy & lactation.
Side Effects / Adverse Reactions
Irritability; pain & redness at injection site, fatigue. Loss of appetite; headache, drowsiness; GI symptoms (eg nausea, vomiting, diarrhea, abdominal pain); swelling & induration at injection site; malaise, fever (≥37.5°C).
Preg Safety (US)
Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
