Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 19 January 2018

Indication(s)

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. (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, 18, 31, 33, 45, 52, and 58:
• 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 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. (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, 18, 31, 33, 45, 52, and 58:
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)

Limitations of Use and Effectiveness:
• GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. (1.3, 17)
• Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider. (1.3, 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. (1.3)
• 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. (1.3)
• GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN. (1.3)
• 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. (1.3)
• GARDASIL 9 does not protect against genital diseases not caused by HPV. (1.3)
• Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. (1.3)
• Safety and effectiveness of GARDASIL 9 have not been assessed in individuals older than 26 years of age. (1.3)

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 9 or 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 tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. 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 (≥10%) local and systemic adverse reactions reported:
• In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0%) and headache (14.6%). (6.1)
• In girls 9 through 15 years of age: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%) and headache (11.4%). (6.1)
• In boys and men 16 through 26 years of age: injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%). (6.1)
• In boys 9 through 15 years of age: injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site erythema (24.9%). (6.1)

Usage information

Dosing and administration
For intramuscular administration only. (2)
Each dose of GARDASIL 9 is 0.5-mL
Administer GARDASIL 9 as follows: (2.1)
 
Age Regimen Schedule
9 through 14 years 2-dose 0, 6 to 12 months*
3-dose 0, 2, 6 months
15 through 26 years 3-dose 0, 2, 6 months

*If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose. (14.2 and 14.5)

Use in special populations
Pregnancy registry: available at 1-800-986-8999. (8.1)

Safety and effectiveness of GARDASIL 9 have not been established in the following populations:
• Children below the age of 9 years. (8.4)
• Immunocompromised individuals. Response to GARDASIL 9 may be diminished. (8.6)

More information

Category Value
Authorisation number BLA125508
Orphan designation No
Product NDC 0006-4119; 0006-4121
Date First Approved 10-12-2014
Marketing authorisation holder Merck Sharp & Dohme Corp.