Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 28 June 2018

Indication(s)

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)

Full Prescribing information

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Advisory information

contraindications
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. (4, 11)
Special warnings and precautions
• Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonicclonic 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)
Adverse reactions
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)

Usage information

Dosing and administration
0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months. (2.1)
Use in special populations
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)

Interactions

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

More information

Category Value
Authorisation number BLA125126
Orphan designation No
Product NDC 0006-4045; 0006-4109; 50090-1523
Date First Approved 08-06-2006
Marketing authorisation holder Merck Sharp & Dohme Corp.