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Human papillomavirus

Every day, ~17,000 new HPV infections occur in the United States1,a,b

  • HPV will infect an estimated 75% to 80% of males and females in their lifetime.2,3,a

Though most HPV infections clear on their own, persistence of certain HPV types can lead to cervical, vulvar, vaginal, and anal cancers, while other HPV types can cause genital warts1

Clinical photo of invasive cervical cancer caused by human papillomavirus Invasive cervical cancer
Clinical photo of female genital warts caused by human papillomavirus Female genital warts
Clinical photo of male genital warts caused by human papillomavirus Male genital wartsc
In the United States, it is estimated that annually there are:

~12,200 new cases of cervical cancer4
~1 million new cases of genital warts5

aNumber represents more than 30 HPV types, not just Types 6, 11, 16, and 18.
bNumber includes both men and women.
cReproduced with permission from DermNetNZ.org. © 2009 New Zealand Dermatological Society Incorporated.

Indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

GARDASIL is a vaccine indicated in females 9 through 26 years of age for the prevention of cervical, vulvar, and vaginal cancers and for males and females 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus (HPV) Types 6, 11, 16, and 18.

GARDASIL does not eliminate the necessity for girls to continue to undergo recommended cervical cancer screening later in life. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care professional.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18.

Select Safety Information for GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

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 vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

GARDASIL is not recommended for use in pregnant women.

The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0% and greater than placebo were fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.

Dosage and Administration for GARDASIL

GARDASIL should be administered in 3 separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a 6-month period with the first dose at an elected date, the second dose 2 months after the first dose, and the third dose 6 months after the first dose.

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

About VARIVAX® (Varicella Virus Vaccine Live)

VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.

Children 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously; if a second 0.5-mL dose is administered, it should be given a minimum of 3 months later.

Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at elected date and a second 0.5-mL dose 4 to 8 weeks later.

Select Safety Information for VARIVAX

VARIVAX is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; an immunodeficient condition or receiving immunosuppressive therapy; active, untreated tuberculosis; active febrile illness; or those who are pregnant.

In children, adolescents, and adults monitored for up to 42 days, the adverse effects most frequently reported were as follows: fever, injection-site complaints, varicella-like rash (injection site), and varicella-like rash (generalized).

In a clinical trial involving children who received 2 doses of VARIVAX 3 months apart, the incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher post-dose 2 (overall incidence 25.4%) than post-dose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower post-dose 2 (66.3%) than post-dose 1 (85.8%).

There are insufficient data to assess the rate of protection of VARIVAX against the serious complications of chickenpox (eg, encephalitis, hepatitis, pneumonia), and during pregnancy (congenital varicella syndrome).

The duration of protection from varicella infection after vaccination with VARIVAX is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination.

Vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.

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

References: 1. Centers for Disease Control and Prevention (CDC). Human papillomavirus. In: Atkinson W, Wolfe C, Hamborsky J, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 11th rev ed. Washington, DC: Public Health Foundation; 2009:123–134. 2. Weaver BA. Epidemiology and natural history of genital human papillomavirus infection. J Am Osteopath Assoc. 2006;106(3, suppl 1):S2–S8. 3. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med. 1997;102(5A):3–8. 4. American Cancer Society (ACS). Cancer Facts & Figures 2010. Atlanta, GA: American Cancer Society; 2010. 5. Fleischer AB Jr, Parrish CA, Glenn R, et al. Condylomata acuminata (genital warts): patient demographics and treating physicians. Sex Transm Dis. 2001;28(11):643–647.