Twinrix

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex

The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including TWINRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Preventing And Managing Allergic Vaccine Reactions

Prior to immunization, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. [See CONTRAINDICATIONS]

Moderate Or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination with TWINRIX should be postponed in persons with moderate or severe acute febrile illness unless they are at immediate risk of hepatitis A or hepatitis B infection.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to TWINRIX.

Multiple Sclerosis

Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis,1 and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.2

Limitations Of Vaccine Effectiveness

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, vaccination with TWINRIX may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

TWINRIX has not been evaluated for its carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

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 needed.

Pregnancy Registry: GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with TWINRIX during pregnancy. Women who receive TWINRIX during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622.

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 have not been established.

Geriatric Use

Clinical studies of TWINRIX did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects [see Clinical Studies].

REFERENCES

1. 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.

2. Confavreux C, Suissa S, Saddier P, et al. Vaccination and the risk of relapse in multiple sclerosis. N Engl J Med. 2001;344(5):319-326.

Last reviewed on RxList: 8/29/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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