Variation of dosing regimen from clinical studies^a


Administration

• GARDASIL should be administered intramuscularly in the deltoid
  region of the upper arm or in the higher anterolateral area of the thigh in 3 separate 0.5-mL doses.
• No dilution or reconstitution is necessary.
• Syncope (fainting) may follow any vaccination and has occurred after vaccination with GARDASIL, so vaccinees should be observed for approximately 15 minutes after administration of GARDASIL.

GARDASIL is a vaccine indicated in girls and women 9 to 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.

Select Safety Information

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening per standard of care.

GARDASIL is not recommended for use in pregnant women.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

GARDASIL is not intended to be used for treatment of active genital warts, cervical cancer, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

GARDASIL has not been shown to protect against diseases due to non-vaccine HPV types.

The vaccine-related adverse experiences that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were pain, swelling, erythema, fever, nausea, pruritus, and dizziness. In addition, common postmarketing reports include vomiting and syncope.

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.

^aBased on the summary of geometric mean titers (GMTs) for variation of dosing regimen.