Product Features for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
Product Features
 
  Homepage for GARDASIL
Product Features
  Indications
  HPV and Your Patients
  Efficacy Data and
    Duration of Protection
  Safety and Tolerability
  Dosage and Administration
  Storage and Handling
  FAQs About GARDASIL
  Prescribing Information
  Patient Product Information
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    Patients and Parents
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  Complimentary Resources
  Disease Information
 
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Exceptional Protection—Cervical Cancer
In combined worldwide clinical studies over a period of 3 to 4 years of young women 16 to 26 years of age naïve to HPV Type 6, 11, 16, or 18,a GARDASIL was 98% effective against HPV 16– and 18–related CIN 2/3 or AIS.

HPV=human papillomavirus.
CIN=cervical intraepithelial neoplasia.
AIS=adenocarcinoma in situ.

Learn more about cervical cancer

A Commitment to Demonstrating Lasting Protection
In a phase 2 extension study, GARDASIL demonstrated efficacy through 5 years. Prophylactic efficacy against overall cervical and genital disease related to HPV Types 6, 11, 16, and 18 in an extension of a phase 2 study (Study 2) was 100% [95% CI, 12.3–100.0] among subjects in the per-protocol population naïve to the relevant HPV types (n=235).1 The duration of protection of GARDASIL is unknown at present.

CI=confidence interval.

Learn more about the duration of protection of GARDASIL


More Protection—Genital Warts and Other HPV Cancers
In combined worldwide clinical studies over a period of 3 to 4 years of young women 16 to 26 years of age naïve to HPV Type 6, 11, 16, or 18,a GARDASIL was 99% effective against HPV 6– and 11–related genital warts and 100% effective against HPV 16– and 18–related VIN 2/3 and VaIN 2/3.

Learn more about genital warts and vulvar/vaginal cancer

Favorable Tolerability Profile
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.

Learn more about tolerability

Dosage and Administration
GARDASIL is given in 3 doses. The first dose is given the day your patient is in the office. The second dose is given 2 months after the first dose, and the third dose is given 6 months after the first dose.

Learn more about administering GARDASIL

Indications

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

GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening.

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

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

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

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

Select Safety Information

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

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 and Patient Product Information.

GARDASIL is a registered trademark of Merck & Co., Inc.

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