USPPI
9883613
Patient Inform ation about
GARDASIL? (pronounced "gard-Ah-sill")
Generic name: [Human Papillom avirus Q uadrivalent (Types 6,11,16, and 18) Vaccine, Recom binant]
Can other vaccines and medications be given at the same
Read this information with care before getting GARDASIL.1
You (the person getting GARDASIL) will need
3
doses of the
vaccine. It is important to read this leaflet when you get each
dose. This leaflet does not take the place of talking with your
health care provider about GARDASIL.
What is GARDASIL?
GARDASIL is a vaccine (injection/shot) that is used for girls
and women
9
through
26
years of age to help protect against
the following diseases caused by Human Papillomavirus (HPV):
• Cervical cancer
• Vulvar and vaginal cancers
• Genital warts
• Abnorm al and precancerous cervical, vaginal, and vulvar
lesions
o The diseases listed above have many causes, and
GARDASIL only protects against diseases caused by
certain kinds of HPV (called Type 6,Type
11
,Type
16
, and
Type
18
). Most of the time, these
4
types of HPV are
responsible for the diseases listed above,
o GARDASIL cannot protect you from a disease that is
caused by other types of HPV, other viruses, or bacteria,
o GARDASIL does not treat HPV infection,
o You cannot get HPV or any of the above diseases from
GARDASIL.
GARDASIL is used for boys and men
9
through
26
years of
age to help protect against genital warts.
What important information about GARDASIL should I know?
• You should continue to get routine cervical cancer screening.
• GARDASIL may not fully protect everyone who gets the
vaccine.
• GARDASIL will not protect against HPV types that you
already have.
Who should not get GARDASIL?
You should not get GARDASIL if you have, or have had:
• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, am orphous aluminum
hydroxyphosphate sulfate, polysorbate
80
.
What should I tell my health care provider before getting
GARDASIL?
Tell your health care provider if you:
• are pregnant or planning to get pregnant. GARDASIL is
not recommended for use in pregnant women.
• have immune problem s, like HIV infection, cancer, or you
take m edicines that affect your immune system.
• have a fever over
100
°F (
37
.
8
°C).
• had an allergic reaction to another dose of GARDASIL.
• take any medicines, even those you can buy over the counter.
Your health care provider will help decide if you should get
the vaccine.
How is GARDASIL given?
GARDASIL is a shot that is usually given in the arm muscle.
You will need
3
shots given on the following schedule:
• Dose
1
: at a date you and your health care provider
choose.
• Dose
2
:
2
months after Dose
1
.
• Dose
3
: 6 months after Dose
1
.
Fainting can happen after getting GARDASIL. Sometimes
people who faint can fall and hurt them selves. For this
reason, your health care provider may ask you to sit or lie
down for
15
minutes after you get GARDASIL. Som e people
who faint might shake or become stiff. This may require
evaluation or treatment by your health care provider.
time as GARDASIL?
GARDASIL can be given at the same time as RECOMBIVAX
H B '1
(hepatitis B vaccine (recombinant)) or Menactra
(M eningococcal (Groups A, C, Y and W-
135
) Polysaccharide
Diphtheria Toxoid Conjugate Vaccine] and Adacel (Tetanus
Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis
Vaccine Adsorbed (Tdap)].
What are the possible side effects of GARDASIL?
The most common side effects with GARDASIL are:
• pain, swelling, itching, bruising, and redness at the
injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting
There w as no increase in side effects when GARDASIL was
given at the same time as RECOMBIVAX HB (hepatitis B
vaccine (recombinant)].
There w as more injection-site swelling at the injection site
for GARDASIL when GARDASIL was given at the same time
as Menactra [Meningococcal (Groups A, C, Y and W-
135
)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and
Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and
Acellular Pertussis Vaccine Adsorbed (Tdap)].
Tell your health care provider if you have any of the following
problem s because these may be signs of an allergic reaction:
• difficulty breathing
• wheezing (bronchospasm )
• hives
• rash
Tell your health care provider if you have:
• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching m uscles
• m uscle weakness
• seizure
• bad stomach ache
• bleeding or bruising more easily than normal
Contact your health care provider right away if you get any
sym ptom s that concern you, even several months after
getting the vaccine.
For a more complete list of side effects, ask your health care
provider.
What are the ingredients in GARDASIL?
The ingredients are proteins of HPV Types 6,
11
,
16
, and
18
,
am orphous aluminum hydroxyphosphate sulfate, yeast
protein, sodium chloride, L-histidine, polysorbate
80
, sodium
borate, and water for injection.
This leaflet is a sum m ary of information about GARDASIL.
If you would like more information, please talk to your health
care provider or visit w w w .gardasil.com .
Make sure that you get all
3
doses on time so that you get the best
protection. If you m iss a dose, talk to your health care provider.
’ Registered tradem ark of M ERCK & CO., Inc.
W h iteh ouse Station, N J 08889, USA
C O P Y R IG H T © 2006 , 2009 M ERCK & CO., Inc.
All rights reserved
Issued June
2010
Manufactured and Distributed by:
MERCK & CO., Inc.
W hitehouse Station, NJ
08889
, USA
21002221
(
11
)(
613
)-GRD-CON
