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Gardasil
USPPI
Patient Information about
GARDASILฎ (pronounced gard-Ah-sill)
Generic name: [Quadrivalent Human Papillomavirus (Types 6,
11, 16, 18) Recombinant Vaccine]
Read this information with care before you or your child
gets GARDASIL*. You or your child will need 3 doses of the
vaccine. It is important to read this leaflet when you
receive each dose. This leaflet does not take the place of
talking with your health care professional about GARDASIL.
What is GARDASIL and what is it used for?
GARDASIL is a vaccine (injection/shot) that helps
protect against the following diseases caused by Human
Papillomavirus (HPV) Types in the vaccine (6, 11, 16, and
18):
Cervical cancer (cancer of the lower end of the uterus
or womb).
Abnormal and precancerous cervical lesions.
Abnormal and precancerous vaginal lesions.
Abnormal and precancerous vulvar lesions.
Genital warts.
GARDASIL helps prevent these diseases but it will not
treat them. You or your child cannot get these diseases from
GARDASIL.
What other key information about GARDASIL should
I know?
Vaccination does not substitute for routine
cervical cancer screening. Females who receive GARDASIL
should continue cervical cancer screening.
As with all vaccines, GARDASIL may not fully protect
everyone who gets the vaccine.
Gardasil will not protect against diseases due to
non-vaccine HPV types. There are more than 100 HPV types;
GARDASIL helps protect against 4 types (6, 11, 16, and 18).
These 4 types have been selected for GARDASIL because they
cause approximately 70% of cervical cancers and 90% of
genital warts.
This vaccine will not protect you against HPV types to
which you may have already been exposed.
GARDASIL also will not protect against other diseases
that are not caused by HPV.
GARDASIL works best when given before you or your child
has any contact with certain types of HPV (i.e., HPV types
6, 11, 16, and 18).
Who can receive GARDASIL?
GARDASIL is for girls and women 9 through 26 years
of age. See Who should not receive GARDASIL? below.
Who should not receive GARDASIL?
Anyone who:
is allergic to any of the ingredients in the vaccine. A
list of ingredients can be found at the end of this leaflet.
has an allergic reaction after getting a dose of the
vaccine.
What should I tell my health care professional
before I am vaccinated or my child is vaccinated with
GARDASIL?
It is very important to tell your health care
professional if you or your child:
has had an allergic reaction to the vaccine.
has a bleeding disorder and cannot receive injections in
the arm.
has a weakened immune system, for example, due to a
genetic defect or HIV infection.
is pregnant or is planning to get pregnant. GARDASIL is
not recommended for use in pregnant women.
has any illness with a fever more than 100ฐF (37.8ฐC).
takes or plans to take any medicines, even those you can
buy over the counter.
Your health care professional will decide if you or your
child should receive the vaccine.
How is GARDASIL given?
GARDASIL is given as an injection.
You or your child will receive 3 doses of the vaccine.
Ideally the doses are given as:
First dose: at a date you and your health care
professional choose.
Second dose: 2 months after the first dose.
Third dose: 6 months after the first dose.
Make sure that you or your child gets all 3 doses. This
allows you or your child to get the full benefits of
GARDASIL. If you or your child misses a dose, your health
care professional will decide when to give the missed dose.
What are the possible side effects of GARDASIL?
As with all vaccines, there may be some side
effects with GARDASIL. GARDASIL has been shown to be
generally well tolerated in women and girls as young as 9
years of age. The most commonly reported side effects
included:
pain, swelling, itching, and redness at the injection
site.
fever.
Difficulty breathing (bronchospasm) has been reported very
rarely.
If you or your child has any unusual or severe symptoms
after receiving GARDASIL, contact your health
care professional right away. For a more complete list of
side effects, ask your health care professional.
What are the ingredients in GARDASIL?
The main ingredients are purified inactive proteins
that come from HPV Types 6, 11, 16, and 18. It also contains
amorphous aluminum hydroxyphosphate sulfate, sodium
chloride, L-histidine, polysorbate 80, sodium borate, and
water for injection.
What are cervical cancer, precancerous lesions,
and genital warts?
Cancer of the cervix is a serious disease that can
be life-threatening. This disease is caused by certain HPV
types that can cause the cells in the lining of the cervix
to change from normal to precancerous lesions. If these are
not treated, they can turn cancerous. Genital warts are
caused by certain types of HPV. They often appear as
skin-colored growths. They are found on the inside or
outside of the genitals. They can hurt, itch, bleed, and
cause discomfort. These lesions are usually not precancerous.
Sometimes, it takes multiple treatments to eliminate these
lesions.
What is Human Papillomavirus (HPV)?
HPV is a common virus. In 2005, the Centers for
Disease Control and Prevention (CDC) estimated that 20
million people in the United States had this virus. There
are many different types of HPV; some cause no harm. Others
can cause diseases of the genital area. For most people the
virus goes away on its own. When the virus does not go away
it can develop into cervical cancer, precancerous lesions,
or genital warts, depending on the HPV type. See What
other key information about GARDASIL should I know?
Who is at risk for Human Papillomavirus?
In 2005, the CDC estimated that at least 50% of
sexually active people catch HPV during their lifetime. A
male or female of any age who takes part in any kind of
sexual activity that involves genital contact is at risk.
Many people who have HPV may not show any signs or symptoms.
This means that they can pass on the virus to others and not
know it.
Will GARDASIL help me if I already have Human
Papillomavirus?
You may benefit from GARDASIL if you already have
HPV. This is because most people are not infected with all
four types of HPV contained in the vaccine. In clinical
trials, individuals with current or past infection with one
or more vaccine-related HPV types prior to vaccination were
protected from disease caused by the remaining vaccine HPV
types. GARDASIL is not intended to be used for treatment for
the above mentioned diseases. Talk to your health care
professional for more information. This leaflet is a summary
of information about GARDASIL. If you would like more
information, please talk to your health care professional (www.passporthealthFL.com)
or visit www.gardasil.com.
Issued June 2006
Manufactured and Distributed by: MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA
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