ADVERSE REACTIONS
RECOMBIVAX HB and RECOMBIVAX HB Dialysis Formulation are generally well-tolerated. No serious adverse reactions attributable to the vaccine have been reported during the course of clinical trials. No adverse experiences were reported during clinical trials which could be related to changes in the titers of antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.
In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever (>/=101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.
In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.
In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported: Incidence Equal to or Greater Than 1% of Injections LOCAL REACTION (INJECTION SITE)
Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, and nodule formation.
BODY AS A WHOLE
The most frequent systemic complaints include fatigue/ weakness; headache; fever (>/=100°F); and malaise.
DIGESTIVE SYSTEM
Nausea; and diarrhea
RESPIRATORY SYSTEM
Pharyngitis; and upper respiratory infection
INCIDENCE LESS THAN 1% OF INJECTIONS
BODY AS A WHOLE
Sweating; achiness; sensation of warmth; lightheadedness; chills; and flushing
DIGESTIVE SYSTEM
Vomiting; abdominal pains/cramps; dyspepsia; and diminished appetite
RESPIRATORY SYSTEM
Rhinitis; influenza; and cough
NERVOUS SYSTEM
Vertigo/dizziness; and paresthesia
INTEGUMENTARY SYSTEM
Pruritus; rash (non-specified); angioedema; and urticaria
MUSCULOSKELETAL SYSTEM
Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; and neck stiffness
HEMIC/LYMPHATIC SYSTEM
Lymphadenopathy
PSYCHIATRIC/BEHAVIORAL
Insomnia/Disturbed sleep
SPECIAL SENSES
Earache
UROGENITAL SYSTEM
Dysuria
CARDIOVASCULAR SYSTEM
Hypotension
MARKETED EXPERIENCE
The following additional adverse reactions have been reported with use of the marketed vaccine. In many instances, the relationship to the vaccine was unclear.
HYPERSENSITIVITY
Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, or symptoms consistent with a hypotensive episode have been reported within the first few hours after vaccination. 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 WARNINGS and PRECAUTIONS).
DIGESTIVE SYSTEM
Elevation of liver enzymes; constipation
NERVOUS SYSTEM
Guillain-Barré Syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis
INTEGUMENTARY SYSTEM
Stevens-Johnson Syndrome; petechiae
MUSCULOSKELETAL SYSTEM
Arthritis
HEMATOLOGIC
Increased erythrocyte sedimentation rate; thrombocytopenia
IMMUNE SYSTEM
Systemic lupus erythematosus (SLE); lupus-like syndrome; vasculitis
PSYCHIATRIC/BEHAVIORAL
Irritability; agitation; somnolence
SPECIAL SENSES
Optic neuritis; tinnitus; conjunctivitis; visual disturbances
CARDIOVASCULAR SYSTEM
Syncope; tachycardia.
The following adverse reaction has been reported with another Heaptitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.
Patients, parents and guardians should be instructed to report any serious adverse reactions to their healthcare provider, who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.
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