Discuss GARDASIL 9 With Appropriate Patients Through Age 45.

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 FOR ADULTS

DISCUSS GARDASIL 9
WITH ADULT PATIENTS
THROUGH AGE 45.

You may be able to help protect them
from certain HPV-related cancers.

Adult Patients May Be at Risk for HPV-related Cancers and Diseases
Adult Patients May Be at Risk for HPV-related Cancers and Diseases

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GARDASIL 9 FOR ADULTS

Discuss GARDASIL 9 With Appropriate Patients Through Age 45.

You may be able to help protect them
from certain HPV-related cancers.

HPV Cancer Incidence

For most people, HPV clears on its own. But, for those who don’t clear the virus, it could cause certain cancers and diseases.1,2,14 There is no way to know which patients who have HPV will develop cancer or other health problems.3

GARDASIL 9 helps protect against certain cancers caused by 7 HPV types

  • CERVICAL
  • VULVAR
  • Oropharyngeal*

*continued approval contingent upon confirmatory trial

  • Vaginal
  • Anal

According to the CDC’s 2012-2016 estimated US model, these HPV types were responsible for:

~31K

Cancer cases per year in
both men and women.16

HPV-related cancers can take years, even decades, to develop after initial infection.1,3,14

US Cancer Statistics assessed incidence of HPV-associated cancers to estimate annual number of cancers caused by HPV, overall, and by state in 2012-2016.16

The estimated number of cancers attributable to HPV was calculated by multiplying the average number of HPV-associated cancers by the percentage of cancers diagnosed from 1993-2005 that were attributable to HPV.16,17

Not all cervical, vulvar, vaginal, anal, and oropharyngeal cancers are caused by HPV.16

Detection of HPV DNA in an HPV study is insufficient to indicate a causal relation with the tumor.17

US HPV Infections

HPV Infections Are Number 1 Most Common STI in the US
1
Estimated 14 Million New HPV Infections Every Year in the US
1
80% of Sexually Active People Will Contract HPV at Some Point in Their Lifetime
18

Abbreviation: STI, sexually transmitted infection.

It’s time to add HPV vaccination to your patient well-visit checklist.

Discussion points:

Patient Well-Visit Checklist Identify appropriate patients through age 45
Item 2 Review transmission of HPV and risks for new infection1
Item 3 Explain the risk of HPV-related cancers for men and women16
Item 4 Discuss vaccine efficacy profile
Item 5 Review safety profile19

It’s time to begin this conversation with patients
through age 45.


ref18

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.
ref1

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.

ref2

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.
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
ref16

Reference

  1. Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human papillomavirus–Attributable Cancers — United States, 2012–2016. MMWR Morb Mortal Wkly Rep. 2019;68:724–728. DOI: http://dx.doi.org/10.15585/mmwr.mm6833a3.
ref17

Reference

  1. Saraiya M, Unger ER, Thompson TD, et al. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. JNCI J Natl Cancer Inst. (2015) 107(6): 1-12. doi: 10.1093/jnci/djv086.
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.
ref19

Reference

  1. Moreira ED Jr, Block SL, Ferris D, et al. Safety profile of the 9-valent HPV vaccine: a combined analysis of 7 phase III clinical trials. Pediatrics. 2016;138(2). pii: e20154387.

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.

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