"The Seasonal Flu Vaccine: What You Need to Know
- Why get vaccinated?
- Inactivated influenza vaccine
- Who should get inactivated influenza vaccine?
- When should I get influenza vaccine?
If Guillain-Barré syndrome 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.
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.
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 to allow an assessment of benefits and risks. Appropriate medical treatment, including epinephrine, and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Limitations of Vaccine Effectiveness
Vaccination with FLULAVAL may not protect all susceptible individuals.
Carcinogenesis, Mutagenesis, Impairment of Fertility
FLULAVAL has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Use In Specific Populations
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 FLULAVAL. There are, however, no adequate and well-controlled 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 pregnant 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/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 pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.
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.
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.
Safety and effectiveness of FLULAVAL in pediatric patients have not been established.
In clinical trials, there were 330 subjects who were ≥ 65 years of age and received FLULAVAL; 142 of these subjects were ≥ 75 years of age. Hemagglutination-inhibiting (HI) 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: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Flulaval Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.