USPPI
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Patient Information about
GARDASIL (pronounced "gard-Ah-sill")
Generic name: [Human Papillomavirus Quadrivalent (Types 6,11,16, and 18) Vaccine, Recombinant]
Read this in form a tio n w ith care before getting GARDASIL
.1
You (the person g e ttin g GARDASIL) w ill need 3 doses
o f the vaccine. It is im p o rta n t to read this leaflet w hen
you get each dose. T his leaflet does not take the place of
ta lkin g w ith y o u r health care p ro v id e r a b o u t GARDASIL.
W hat is G A R D A SIL?
G ARDASIL is a vaccine (in je ctio n /sh o t) th a t is used
fo r g irls and w o m e n 9 th ro u g h 26 years o f age to help
p ro te ct against the fo llo w in g diseases caused by H um an
P a p illom avirus (HPV):
• C ervical cancer
• V ulvar and vaginal cancers
• G enital w a rts
• A b n o rm a l and precancerous cervical, vaginal, and
v u lv a r lesions
o
The diseases listed above have m any causes, and
G ARDASIL o n ly p ro te cts against diseases caused
by certain kinds of HPV (called Type
6
,Type 11,Type 16,
and Type 18). M o st o f the tim e, these 4 typ e s o f HPV
are responsible fo r the diseases listed above,
o GARDASIL cannot pro te ct you fro m a disease th a t is
caused by other types of HPV, other viruses, or bacteria,
o G ARDASIL does not tre a t HPV in fectio n .
° You cannot get HPV or any o f the above diseases
fro m GARDASIL.
G ARDASIL is used fo r boys and m en 9 th ro u g h 26 years
o f age to help p ro te ct against genital w arts.
W hat im portant inform ation about G A R D A SIL should
I know ?
• You should co n tin u e to get ro u tin e cervical cancer
screening.
• G ARDASIL m ay not fu lly p ro te ct everyone w h o gets
the vaccine.
• G ARDASIL w ill not p ro te ct against HPV typ e s th a t
you already have.
W ho should not get G A R D A SIL?
You should not get G ARDASIL if you have, or have had:
• an allergic reaction a fte r g e ttin g a dose o f GARDASIL.
• a severe a lle rg ic reaction to yeast, a m o rp h o u s
a lu m in u m h yd ro xyp h o sp h a te sulfate, p o lyso rb a te 80.
W hat should I tell m y health care provider before
getting G A R D A SIL?
Tell y o u r health care p ro vid e r if you:
• are p regnant or p lanning to get pregnant. GARDASIL
is not re com m ended fo r use in p regnant w om e n .
• have im m u n e p roblem s, like HIV in fe ctio n , cancer, or
you take m edicines th a t a ffe ct y o u r im m u n e system .
• have a fe ve r over 100°F (37.8°C).
• had an allergic reaction to another dose o f GARDASIL.
• take any m edicines, even those you can buy over the
counter.
Your health care p ro vid e r w ill help decide if you should
get the vaccine.
F ainting can happen a fte r g e ttin g G ARDASIL.
S o m e tim e s p e o p le w h o fa in t can fa ll and h u rt
th e m se lve s. For this reason, y o u r health care p ro v id e r
m ay ask you to sit or lie d o w n fo r 15 m in u te s a fte r you
get G ARDASIL. S om e people w h o fa in t m ig h t shake or
becom e s tiff. T his m ay require e va lu a tion o r tre a tm e n t
by y o u r health care provider.
M ake sure th a t you get all 3 doses on tim e so th a t you
get the best p ro te ctio n . If you m iss a dose, talk to yo u r
health care provider.
W hat are the possible side effects of G A R D A SIL?
The m o st co m m o n side e ffects w ith G ARDASIL are:
• pain, sw ellin g, itch in g , b ru isin g , and redness at the
in je ctio n site
• headache
• fever
• nausea
• dizziness
• v o m itin g
• fa in tin g
Tell y o u r health care p ro vid e r if you have any o f the
fo llo w in g p ro b le m s because these m ay be signs o f an
a lle rg ic reaction:
• d iffic u lty breathing
• w heezing (bronchospasm )
• hives
• rash
Tell y o u r health care p ro vid e r if you have:
• sw o lle n glands (neck, a rm p it, or groin)
• jo in t pain
• unusual tiredness, w eakness, or co n fu sio n
• chills
• g e n e ra lly feeling unw ell
• leg pain
• shortness o f breath
• chest pain
• aching m uscles
• m uscle w eakness
• seizure
• bad stom ach ache
• bleeding or b ru isin g m ore easily than norm al
C ontact yo u r health care p ro v id e r rig h t aw ay if you get
any sym p to m s th a t concern you, even several m onths
a fte r g e ttin g the vaccine.
For a m ore co m p le te list o f side e ffects, ask yo u r health
care provider.
W hat are the ingredients in G A R D A SIL?
The in g re d ie n ts are p ro te in s o f HPV Types
6
, 11, 16, and
18, a m o rp h o u s a lu m in u m h yd ro xyp h o sp h a te sulfate,
yeast protein, sodium chloride, L-histidine, polysorbate 80,
sodium borate, and w a te r fo r injection.
How is G A R D A SIL given?
GARDASIL is a shot that is usually given in the arm m uscle.
You w ill need 3 shots given on the fo llo w in g schedule:
• Dose 1: at a date you and yo u r health care p ro vid e r
choose.
• Dose 2: 2 m o n th s a fte r Dose 1.
• Dose 3:
6
m o n th s a fte r Dose 1.
’ R e g iste re d tra d e m a rk o f M E R C K & C O ., In c.
W h ite h o u se S ta tio n , N J 0 8 8 8 9 , U S A
C O P Y R IG H T © 2 0 0 9 M E R C K & C O ., In c.
A ll rig h ts re se rv e d
This leaflet is a su m m ary o f in fo rm a tio n about GARDASIL.
If you w o u ld like m ore in fo rm a tio n , please ta lk to yo u r
health care p ro vid e r or v is it w w w .g a rd a s il.c o m .
Issued O ctober 2009
M an ufa ctu re d and D istrib u te d by:
MERCK & CO., Inc.
W h ite ho u se S tation, NJ 08889, USA
21002221 (5)(612)-GRD-CON
