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These highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9. GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 2014
Medication labelWhy this: Advisory · dailymed-other
GARDASIL®9 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 Genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS) Cervical intraepithelial neoplasia (CIN) grade 1 Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 GARDASIL 9 is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases: Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 Genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL 9 should continue to undergo cervical cancer screening per standard of care. [See Patient Counseling Information (17).] Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider [see Patient Counseling Information (17)]. GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity. GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN. Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 does not protect against genital diseases not caused by HPV. Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. Safety and effectiveness of GARDASIL 9 have not been assessed in individuals older than 26 years of age.
- generic_name
- human papillomavirus 9-valent vaccine, recombinant
- product_names
- Human Papillomavirus 9-valent Vaccine, Recombinant
- ndc
- 50090-2443, 0006-4119, 50090-2443-0
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en