9883612
USPPI
Patient Information about
GARDASIL® (pronounced “gard-Ah-sill")
Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
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
• Abnormal and precancerous cervical, vaginal, and
vulvar lesions
° 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.
° GARDASIL cannot protect you from a disease that is
caused by other types of HPV, other viruses, or bacteria.
° GARDASIL does not treat HPV infection.
° 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, amorphous
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 problems, like HIV infection, cancer, or
you take medicines that affect your immune system.
• have a fever over 100°F (37.8°C).
• had an allergic reaction to another dose of GARDASIL.
• t ake 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
themselves. For this reason, your health care provider
may ask you to sit or lie down for 15 minutes after you
get GARDASIL. Some people who faint might shake or
become stiff. This may require evaluation or treatment
by your health care provider.
Make sure that you get all 3 doses on time so that you
get the best protection. If you miss a dose, talk to your
health care provider.
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
• f ever
• nausea
• dizziness
• vomiting
• f ainting
Tell your health care provider if you have any of the
following problems 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)
• t oint pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unwell
• l eg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache
• bleeding or bruising more easily than normal
Contact your health care provider right away if you get
any symptoms 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, amorphous aluminum hydroxyphosphate sulfate,
yeast protein, sodium chloride, L-histidine, polysorbate 80,
sodium borate, and water for injection.
This leaflet is a summary of information about GARDASIL.
If you would like more information, please talk to your
health care provider or visit www.gardasil.com.
Issued October 2009
Manufactured and Distributed by:
''Registered trademark of MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA
COPYRIGHT © 2009 MERCK & CO., Inc.
All rights reserved
MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA
21002221(3)(612)-GRD-CON
