FDA label 1e70e010-b946-4dff-b5c8-ab712eeddd75

WARNINGS 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. The vial stopper does not contain latex. (See HOW SUPPLIED.) 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 individual infant’s medical status, and the potential benefits and possible risks of vaccination. 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. Hepatitis B has a long incubation period. Hepatitis B vaccination may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.

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-Barré 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.