GARDASIL 9 FOR ADOLESCENTS

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;
Vaccinating Before Exposure to HPV May Help Prevent Cancers Later in Life

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GARDASIL 9 FOR ADOLESCENTS

Take a Stand

Against Certain HPV-Related Cancers

Vaccinating May Help Prevent These Cancers Later in Life1,2,3

Actor Portrayals

Why vaccinate at ages 11-12?

Vaccinate Well Before Exposure—HPV vaccination is a type of cancer prevention. Adolescents can be exposed to HPV through any sexual activity, including skin‐to‐skin contact.1,12,13

For most people, HPV clears on its own. But for those who don’t clear the virus, it could cause certain cancers and diseases later in life.1,2,3,14

Routine Visits May Decline—As your patients get older, they may be less likely to come in for routine well-visits.15

The CDC recommends vaccinating at ages 11-12.6

‘How to Recommend’ Video Series

The Foundation of a Strong Recommendation
The Four Essential Components of a Strong Recommendation
Addressing Parental Hesitation: Using Motivational Interviewing Techniques
Addressing Parental Hesitation: Discussing Whether or Not “This Can Wait”

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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.

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Reference

  1. Centers for Disease Control and Prevention (CDC). HPV and oropharyngeal cancer. https://www.cdc.gov/cancer/hpv/ basic_info/hpv_oropharyngeal.htm. Last reviewed March 14, 2018. Accessed September 10, 2020.
ref3

Reference

  1. Centers for Disease Control and Prevention (CDC). Types of cancer caused by HPV. https://www.cdc.gov/hpv/parents/cancer.html. Last reviewed April 29, 2019. Accessed September 16, 2020.
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Reference

  1. Centers for Disease Control and Prevention (CDC). Human papillomavirus (HPV). Reasons to get vaccinated. https://www.cdc.gov/hpv/parents/vaccine/six-reasons.html. Last reviewed March 26, 2019. Accessed September 16, 2020.
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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.
ref12

Reference

  1. Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance  — United States, 2017. MMWR Surveill Summ. 2018;67(No. SS-8):1 -114. DOI:http://dx.doi.org/10.15585/mmwr.ss6708a1
ref13

Reference

  1. Centers for Disease Control and Prevention (CDC). Human Papillomavirus (HPV) – About HPV. https://www.cdc.gov/hpv/parents/about-hpv.html. Last Reviewed April 29, 2019. Accessed September 16, 2020.
ref14

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 September 16, 2020.
ref15

Reference

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-GSL-01415.

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-02513 10/20