GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58;

Recommending HPV Vaccination for 19- to 26-Year-Olds

Help protect appropriate patients against certain HPV-related cancers and diseases

YOUR PATIENTS MAY BE AT
RISK FOR NEW HPV INFECTIONS
AND CERTAIN RELATED
CANCERS1,2,8

Adult Patients May Be at Risk for HPV-related Cancers and Diseases
HPV Infections in the United States

An estimated 14 million new anogenital HPV infections occur every year in the US.2

HPV-related Cervical Cancers

ACCORDING TO A MODELING STUDY, HPV infections acquired by about age 20 account for approximately half of all HPV-related cervical cancers absent primary or secondary intervention.17

FOR MOST PEOPLE, HPV CLEARS ON ITS OWN. But, for those who don’t clear the virus, it could cause certain cancers and diseases.1,2,3 There is no way to know which patients who have HPV will develop cancer.18

In a 2017 survey, the CDC estimated that among adults ages 19 to 26: ~48% of females and ~78% of males had not received any dose of the HPV vaccine.19,a

  1. aSubset of data from National Health Interview Survey (NHIS) surveys of 19- to 26-year-olds (females n=1,322; males n=1,200). Response rate was 53% (total adult sample=26,430).19

Vaccinate your appropriate male and female patients to help protect them from certain HPV-related cancers.1,8

CDC=Centers for Disease Control and Prevention; HPV=human papillomavirus.

ref1

Reference

  1. Centers for Disease Control and Prevention (CDC). 2015 sexually transmitted diseases treatment guidelines: human papillomavirus (HPV) infection. https://www.cdc.gov/std/tg2015/hpv.htm. Last reviewed June 4, 2015. Accessed February 3, 2020.

ref2

Reference

  1. Centers for Disease Control and Prevention (CDC). Human papillomavirus. In: Hamborsky J, Kroger A, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington DC: Public Health Foundation; 2015:175-186.

ref3

Reference

  1. Centers for Disease Control and Prevention (CDC). HPV and oropharyngeal cancer. https://www.cdc.gov/cancer/hpv/ basic_info/hpv_oropharyngeal.htm. Published March 14, 2018. Accessed January 21, 2020.
ref8

Reference

  1. Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human papillomavirus vaccination for adults: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68(32):698-702.
ref17

Reference

  1. Burger EA, Kim JJ, Sy S, Castle PE. Age of acquiring causal human papillomavirus (HPV) infections: leveraging simulation models to explore the natural history of HPV-induced cervical cancer. Clin Infect Dis. 2017;65(6):893-899.
ref18

Reference

  1. Centers for Disease Control and Prevention (CDC). Types of cancer caused by HPV. https://www.cdc.gov/hpv/parents/cancer.html. Published April 29, 2019. Accessed March 9, 2020.
ref19

Reference

  1. Centers for Disease Control and Prevention (CDC). AdultVaxView Vaccination Coverage Among Adults In the United States, National Health Interview Survey, 2017. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/NHIS-2017.html. Published February 8, 2018. Accessed January 24, 2020.

Indication for GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

GARDASIL ®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

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.

Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema.

The duration of immunity of GARDASIL 9 has not been established.

Dosage and Administration for GARDASIL 9

GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

  • For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months.
  • For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months.

Before administering GARDASIL 9, please read the Prescribing Information. The Patient Information also is available.

GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.

GARDASIL 9 has not been demonstrated to provide protection against diseases caused by:

  • HPV types not covered by the vaccine
  • HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.


US-GSL-01920 06/20