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Flucelvax

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Flucelvax

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barre Syndrome

The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barre syndrome (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 1 additional case per 1 million persons vaccinated.1 If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX should be based on careful consideration of the potential benefits and risks.

Latex

The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latexsensitive individuals. [see DESCRIPTION]

Preventing and Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Altered Immunocompetence

After vaccination with FLUCELVAX, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response. [See Concurrent use with Immunosuppresive Therapies]

Limitations of Vaccine Effectiveness

Vaccination with FLUCELVAX may not protect all vaccine recipients against influenza disease.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

FLUCELVAX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.

FLUCELVAX did not affect female fertility in a rabbit reproductive and developmental toxicity study.

Use In Specific Populations

Pregnancy

Pregnancy Category B

A reproductive and developmental toxicity study has been performed in rabbits with a dose level that was approximately 15 times the human dose based on body weight. The study revealed no evidence of impaired female fertility or harm to the fetus due to FLUCELVAX. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.

In a reproductive and developmental toxicity study, the effect of FLUCELVAX on embryo-fetal and post-natal development was evaluated in pregnant rabbits. Animals were administered FLUCELVAX by intramuscular injection 3 times prior to gestation, during the period of organogenesis (gestation day 7) and later in pregnancy (gestation day 20), 0.5 mL/rabbit/occasion (approximately 15-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, embryo-fetal development, or post-natal development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis.

Nursing Mothers

FLUCELVAX has not been evaluated in nursing mothers. It is not known whether FLUCELVAX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUCELVAX is administered to a nursing woman.

Pediatric Use

Safety and effectiveness have not been established in children less than 18 years of age.

Geriatric Use

Of the total number of subjects who received one dose of FLUCELVAX in clinical studies (6711), 9% (572) were 65 years of age and older and 2% (140) were 75 years or older.

The majority of local and general adverse events were reported less frequently in adults 65 years of age and older as compared to adults < 65 years of age. [See ADVERSE REACTIONS]

Antibody responses to FLUCELVAX were lower in the geriatric (adults 65 years and older) population than in younger subjects. [see Clinical Studies]

REFERENCES

1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998; 339(25):1797-1802.

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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