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Fluarix

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Fluarix

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barre Syndrome

If Guillain-Barre syndrome (GBS) has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX should be based on careful consideration of the potential benefits and risks.

The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is inconclusive. If influenza vaccine does pose a risk, it is probably slightly more than one additional case/one million persons vaccinated.

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX. 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 administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of FLUARIX.

Altered Immunocompetence

If FLUARIX is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.

Limitations Of Vaccine Effectiveness

Vaccination with FLUARIX may not protect all susceptible individuals.

Persons At Risk Of Bleeding

As with other intramuscular injections, FLUARIX should be given with caution in individuals with bleeding disorders such as hemophilia or on anticoagulant therapy, to avoid the risk of hematoma following the injection.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Use In Specific Populations

Pregnancy

Pregnancy Category B

A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 56 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to FLUARIX. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLUARIX should be given to a pregnant woman only if clearly needed.

In a reproductive and developmental toxicity study, the effect of FLUARIX on embryofetal and pre-weaning development was evaluated in pregnant rats. Animals were administered FLUARIX by intramuscular injection once prior to gestation, and during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 56-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or preweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.

Pregnancy Registry

GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with FLUARIX during pregnancy. Women who receive FLUARIX 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 FLUARIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUARIX is administered to a nursing woman.

Pediatric Use

The immune response to FLUARIX has been evaluated in children 6 months through 4 years of age. In a randomized, controlled study, serum hemagglutination-inhibition (HI) antibody titers were lower in children 6 months through 35 months of age compared to a USlicensed vaccine. Based on these data, FLUARIX is not approved for use in children younger than 3 years of age. Immune responses in children 3 years through 4 years of age receiving FLUARIX or a US-licensed vaccine have been evaluated [see Clinical Studies]. Safety has been evaluated in children 6 months through 17 years of age. The frequencies of solicited and unsolicited adverse events for children 3 years through 4 years of age and for children 5 years through 17 years of age were similar for FLUARIX and the comparator vaccine [see ADVERSE REACTIONS].

Geriatric Use

A randomized, single-blind, active-controlled study evaluated immunological non-inferiority in a cohort of subjects 65 years of age and older who received FLUARIX (N = 606) or another US-licensed trivalent, inactivated influenza vaccine (N = 604) (Sanofi Pasteur SA). In subjects receiving FLUARIX or the comparator vaccine, geometric mean antibody titers post-vaccination were lower in geriatric subjects than in younger subjects (18 through 64 years of age). FLUARIX was non-inferior to the comparator vaccine for each of the 3 influenza strains based on mean antibody titers and seroconversion rates. [See Clinical Studies] Solicited local and general adverse events were similar for FLUARIX and the comparator vaccine among geriatric subjects (Table 3). For both vaccines, the frequency of solicited events in subjects 65 years of age and older was lower than in younger subjects (Table 3). [See ADVERSE REACTIONS]

Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

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