GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

• Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18 (1.1)
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11 (1.1)

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

• Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS) (1.1)
• Cervical intraepithelial neoplasia (CIN) grade 1 (1.1)
• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 (1.1)
• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 (1.1)
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 (1.1)

GARDASIL is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

• Anal cancer caused by HPV types 16 and 18 (1.2)
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11 (1.2)

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)

Limitations of GARDASIL Use and Effectiveness:

• GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. (1.3, 17)
• Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider. (1.3, 17)
• GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. (1.3, 14.4, 14.5)
• GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN, or AIN. (1.3)
• GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. (1.3, 14.4, 14.5)
• 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 16 and 18. (1.3)
• GARDASIL does not protect against genital diseases not caused by HPV. (1.3)
• Vaccination with GARDASIL may not result in protection in all vaccine recipients. (1.3)
• GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. (14.7)

• 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 by maintaining a supine or Trendelenburg position. (5.1)

The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

GARDASIL may be administered concomitantly with RECOMBIVAX HB® (7.1) or with Menactra and Adacel. (7.2)

Safety and effectiveness of GARDASIL have not been established in the following populations:

• Pregnant women. Women who receive GARDASIL during pregnancy are encouraged to contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231. (8.1)
• Children below the age of 9 years. (8.4)
• Immunocompromised individuals. Response to GARDASIL may be diminished. (8.6)