Twinrix

Twinrix

WARNINGS

There have been rare reports of anaphylaxis/anaphylactoid reactions following routine clinical use of TWINRIX. (See ADVERSE REACTIONS, Postmarketing Reports.)

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. The vial stopper is latex-free.

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: Prior to immunization with TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) , the patient's current health status and medical 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 (hepatitis a inactivated & hepatitis b (recombinant) vaccine) and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available. As with other vaccines, although a moderate or severe acute illness is sufficient reason to postpone vaccination, minor illnesses such as mild upper respiratory infections with or without low-grade fever are not contraindications.20

TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) should be given with caution in persons with bleeding disorders such as hemophilia or thrombocytopenia and in persons on anticoagulant therapy, with steps taken to avoid the risk of hematoma following the injection.20

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent the transmission of other infectious agents from person to person. Needles should be disposed of properly and should not be recapped.

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

Multiple Sclerosis: Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis,21 and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.22

Carcinogenesis, Mutagenesis, Impairment of Fertility: TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) 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 (hepatitis a inactivated & hepatitis b (recombinant) vaccine) . It is also not known whether TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) 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: Healthcare providers are encouraged to register pregnant women who receive TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) in the GlaxoSmithKline vaccination pregnancy registry by calling 1-888-825-5249.

Nursing Mothers: It is not known whether TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric Use: Clinical studies of TWINRIX (hepatitis a inactivated & hepatitis b (recombinant) vaccine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

References

20. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.
21. Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med 2001;344(5):327-332.
22. Confavreux C, Suissa S, Saddier P, et al. Vaccination and the risk of relapse in multiplesclerosis. N Engl J Med 2001;344(5):319-326.

Last reviewed on RxList: 4/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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