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Flulaval

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Flulaval

Flulaval

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 FLULAVAL should be based on careful consideration of the potential benefits and risks.

The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, 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 FLULAVAL. 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 FLULAVAL.

Altered Immunocompetence

If FLULAVAL 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 FLULAVAL may not protect all susceptible individuals.

Persons at Risk of Bleeding

As with other intramuscular injections, FLULAVAL 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

FLULAVAL has not been evaluated for carcinogenic or mutagenic potential. Vaccination of female rats with FLULAVAL, at doses shown to be immunogenic in the rat, had no effect on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B

A reproductive and developmental toxicity study has been performed in female rats at a dose 40-fold the human dose (on a mg/kg basis) and showed no evidence of impaired female fertility or harm to the fetus due to FLULAVAL. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLULAVAL should be given to a pregnant woman only if clearly needed.

In a reproductive and developmental toxicity study, the effect of FLULAVAL on embryo-fetal and pre-weaning development was evaluated in rats. Animals were administered FLULAVAL by intramuscular injection once prior to gestation, and during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/dose/rat (approximately 40-fold higher than the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning 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 FLULAVAL during pregnancy. Women who receive FLULAVAL 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 FLULAVAL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLULAVAL is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of FLULAVAL in children younger than 3 years of age have not been established.

Safety and immunogenicity of FLULAVAL in children 3 through 17 years of age have been evaluated [see ADVERSE REACTIONS and Clinical Studies].

Geriatric Use

In clinical trials, there were 330 subjects 65 years of age and older who received FLULAVAL; 142 of these subjects were 75 years of age and older. Hemagglutination inhibition antibody responses were lower in geriatric subjects than younger subjects after administration of FLULAVAL. [See Clinical Studies] Solicited adverse events were similar in frequency to those reported in younger subjects [see ADVERSE REACTIONS].

Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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