"The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the preve"...
- Patient Information:
Details with Side Effects
Fever and Febrile Seizures
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age.
If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA 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 unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.
Preventing and Managing Allergic Reactions
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Limitations of Vaccine Effectiveness
Vaccination with AFLURIA may not protect all individuals.
Carcinogenesis, Mutagenesis, Impairment of Fertility
AFLURIA has not been evaluated for carcinogenic or mutagenic potential.
Use In Specific Populations
Pregnancy Category B
A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed.
In the reproductive and developmental toxicity study, the effect of AFLURIA on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered AFLURIA by intramuscular injection twice prior to gestation, once during the period of organogenesis (gestation day 6), and once later in pregnancy (gestation day 20), 0.5 mL/rat/occasion (approximately a 265- 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.
AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman.
AFLURIA is not approved for use in children less than 5 years of age. In a clinical study in which children received AFLURIA or a US-licensed comparator vaccine (Study 1, see Clinical Trials Experience), the incidence of fever in children 6 months to less than 3 years of age following the first and second doses of AFLURIA were 37% and 15%, respectively, as compared to 14% following each dose in the comparator group. Among children 3 years to less than 5 years of age, the incidence of fever following the first and second doses of AFLURIA were 32% and 14%, respectively, as compared to 11% and 16% in the comparator. In an open-label study (Study 2), fever, irritability, loss of appetite, and vomiting/diarrhea occurred more frequently in children 6 months to less than 3 years of age as compared to older children. Across three pediatric studies of AFLURIA (Studies 1, 2, and 3), 1.2% of eligible children (n=1,764) were discontinued from the second vaccination because of severe fever ( ≥ 104°F) within 48 hours of the first vaccination. Across the three pediatric studies, two children, a 7-month old and a 3-year old, experienced vaccine-related febrile seizures (rate of 0.07% across studies), one of which was serious.
Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures, predominantly in children below the age of 5 years as compared to previous years, in postmarketing reports confirmed by postmarketing studies (see WARNINGS AND PRECAUTIONS).
In clinical studies, AFLURIA has been administered to, and safety information collected for, 836 subjects ages 65 years and older (see Clinical Trials Experience). After administration of AFLURIA, hemagglutination-inhibiting antibody responses in persons 65 years of age and older were lower as compared to younger adult subjects (see Clinical Studies).
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Afluria 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 out what women really need.