"The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
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Prevention And Management Of Allergic Vaccine Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see CONTRAINDICATIONS].
Hypersensitivity To Latex
The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals [see HOW SUPPLIED/Storage and Handling].
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VAQTA and may not be protected against HAV infection after vaccination [see Use in Specific Populations].
Limitations Of Vaccine Effectiveness
Hepatitis A virus has a relatively long incubation period (approximately 20 to 50 days). VAQTA may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Use In Specific Populations
Pregnancy Category C: Animal reproduction studies have not been conducted with VAQTA. It is also not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA should be given to a pregnant woman only if clearly needed.
It is not known whether VAQTA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VAQTA is administered to a nursing woman.
The safety of VAQTA has been evaluated in 4374 children 12 through 23 months of age, and 2615 children/adolescents 2 through 18 years of age who received at least one 25U dose of VAQTA [see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION].
Safety and effectiveness in infants below 12 months of age have not been established.
In the post-marketing observational safety study which included 42,110 persons who received VAQTA [see ADVERSE REACTIONS], 4769 persons were 65 years of age or older and 1073 persons were 75 years of age or older. There were no adverse events judged by the investigator to be vaccine-related in the geriatric study population. In other clinical studies, 68 subjects 65 years of age or older were vaccinated with VAQTA, 10 of whom were 75 years of age or older. No overall differences in safety and immunogenicity were observed between these subjects and younger subjects; however, greater sensitivity of some older individuals cannot be ruled out. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
Immunocompromised persons may have a diminished immune response to VAQTA and may not be protected against HAV infection.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/1/2016
Additional Vaqta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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