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.
VIN=vulvar intraepithelial neoplasia.
VaIN=vaginal intraepithelial neoplasia.
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.
aStudy
Design: Four placebo-controlled, double-blind,
randomized clinical studiesb evaluated the efficacy
of GARDASIL in women 16 to 26 years of age at enrollment.
Efficacy was measured after 1 month postdose 3, with
median duration of follow-up from 3 to 4 years. Subjects
received vaccine or placebo on the day of enrollment,
and 2 and 6 months thereafter.
bThe first phase 2 study evaluated
the HPV 16 component of GARDASIL (n=2,391),
and the second evaluated all 4 components
of GARDASIL (n=551). The phase 3 studies,
called FUTURE (Females United To Unilaterally
Reduce Endo/Ectocervical Disease), evaluated
GARDASIL in 5,442 (FUTURE I) and 12,157 (FUTURE
II) women.
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