WARNINGS
There have been rare reports of anaphylaxis/anaphylactoid reactions following routine clinical use of TWINRIX. (See CONTRAINDICATIONS.)
The vial stopper is latex-free. The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
Hepatitis A and hepatitis B have relatively long incubation periods. The vaccine may not prevent hepatitis A or hepatitis B infection in individuals who have an unrecognized hepatitis A or hepatitis B infection at the time of vaccination. Additionally, it may not prevent infection in individuals who do not achieve protective antibody titers.
PRECAUTIONS
General: As with other vaccines, although a moderate or severe acute illness is sufficient reason to postpone vac-cination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications. 22 Multiple Sclerosis: Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis,23 and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.24
TWINRIX should be administered with caution to people on anticoagulants, and those with thrombocytopenia or a bleeding disorder since bleeding may occur following intramuscular administration to these subjects.
As with any vaccine, if administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected immune response may not be obtained. 25
Before the injection of any vaccine, the physician should take all reasonable precautions to prevent allergic or other adverse reactions, including understanding the use of the vaccine concerned, and the nature of the side effects and adverse reactions that may follow its use.
Prior to immunization with any vaccine, the patient's history should be reviewed. The physician should review the patient's immunization history for possible vaccine sensitivity, previous vaccination-related adverse reactions, and occurrence of any adverse event-related symptoms and/or signs in order to determine the existence of any contraindication to immunization with TWINRIX and to allow an assessment of benefits and risks. As with any parenteral vaccine, epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
A separate sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent the transmission of infectious agents from person to person. Needles should be disposed of properly and should not be recapped. Information for Patients: Patients should be informed of the benefits and risks of immunization with TWINRIX, and of the importance of completing the immunization series. As with any vaccine, it is important when a subject returns for the next dose in a series that he or she be questioned concerning the occurrence of any symptoms and/or signs after a previous dose of the same vaccine and that adverse events be reported. The US Department of Health and Human Services has established the Vaccine Adverse Events Reporting System (VAERS) to accept reports of suspected adverse events after the administration of any vaccine including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS forms and information is 1-800-822-7967. 26 Carcinogenesis, Mutagenesis, Impairment of Fertility: TWINRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with TWINRIX. It is also not known whether TWINRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TWINRIX should be given to a pregnant woman only if clearly indicated (see INDICATIONS AND USAGE).
Pregnancy Exposure Registry: Health care providers are encouraged to register pregnant women who receive TWINRIX in the GlaxoSmithKline vaccination pregnancy registry by calling 1-888-825-5249. Nursing Mothers: It is not known whether TWINRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TWINRIX is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years has not been established. Geriatric Use: Clinical studies of TWINRIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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