Trade name: Engerix-b, RECOMBIVAX HB®
Generic names: Hepatitis B Vaccine (Recombinant) injectable suspension for intramuscular use.
Indication and Usage: The FDA has approved this vaccine for immunization against infection caused by all known subtypes of hepatitis B virus.
Ingredients:
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) is a sterile suspension of non-infectious subunit viral vaccine derived from HBsAg produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is adsorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. The vaccine contains <15 mcg/mL residual formaldehyde.
- Pediatric/Adolescent Formulation (Without Preservative), 10 mcg/mL: each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
- Adult Formulation (Without Preservative), 10 mcg/mL: each 1 mL dose contains 10 mcg of hepatitis B surface antigen.
- Dialysis Formulation (Without Preservative), 40 mcg/mL: each 1 mL dose contains 40 mcg of hepatitis B surface antigen.
ENGERIX-B [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious HBsAg for intramuscular administration. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. ENGERIX-B contains the following excipients: Sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).
Manufacturer-listed adverse reactions | Hep B vaccine can cause:
Engerix-b can cause: Herpes zoster (Shingles), Meningitis, Thrombocytopenia, Allergic/anaphylactoid reaction, anaphylaxis, Hypersensitivity syndrome (serum sickness-like), Arthralgia/arthritis, Fever, Urticaria (hives), Erythema multiforme/nodosum, Ecchymoses, Encephalitis, Visual disturbances, Earache, Tinnitus, Vertigo, Palpitations, Tachycardia, Vasculitis, Apnea, Bronchospasm including asthma-like symptoms, Dyspepsia, Alopecia (baldness), Angioedema, Encephalopathy, Migraine, Multiple sclerosis, Neuritis, Paralysis, Paresis, Seizures, Syncope (fainting), Transverse myelitis, Conjunctivitis (pink eye), Keratitis, Eczema, Erythema multiforme including Stevens-Johnson syndrome, Lichen planus, Purpura, Arthritis, Muscular weakness, Injection site reaction, Abnormal liver function tests, Neuropathy: hypoesthesia, paresthesia, Guillain-Barré syndrome, Bell’s palsy, optic neuritis.
RECOMBIVAX HB® can cause: Anaphylactic/anaphylactoid reactions, Bronchospasm, Urticaria (Hives), Hypersensitivity syndrome (serum-sickness-like), Arthralgia/arthritis, Fever, Erythema multiforme, Ecchymoses and erythema nodosum, Systemic lupus erythematosus (SLE), Lupus-like syndrome, Vasculitis, Polyarteritis nodosa, Elevation of liver enzymes, Constipation, Guillain-Barré syndrome, Multiple sclerosis, Transverse myelitis, Seizure/febrile seizure, Radiculopathy, Herpes zoster (Shingles), Migraine, Muscle weakness, Hypesthesia, Encephalitis, Stevens-Johnson syndrome, Alopecia (baldness), Petechiae, Eczema, Pain in extremity, Increased erythrocyte sedimentation rate, Thrombocytopenia, Irritability, Agitation, Somnolence, Optic neuritis, Tinnitus (ringing ears), Conjunctivitis (Pink eye), Visual disturbances, Uveitis, Syncope (Fainting), Tachycardia, and Peripheral neuropathy including Bell’s Palsy.
Need more info? Click the link below for a helpful infographic you can view + save on your device.
