Select Safety Information for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
Indication
GARDASIL is a vaccine indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, and vaginal cancers and for males and females 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.
GARDASIL does not eliminate the necessity for girls to continue to undergo recommended cervical cancer screening later in life. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care professional.
GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).
GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.
Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18.
Select Safety Information
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.
GARDASIL is not recommended for use in pregnant women.
The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
Dosage and Administration
GARDASIL should be administered in 3 separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a 6-month period with the first dose at an elected date, the second dose 2 months after the first dose, and the third dose 6 months after the first dose.
Before administering GARDASIL, please read the Prescribing Information and Patient Product Information.
