GARDASIL Understanding how to prevent cerviical cancer

The main ingredients are highly purified inactive proteins from Human Papillomavirus Types 6, 11, 16, and 18.¹

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1. What are cervical cancer, precancerous lesions, and genital warts?
2. What is HPV?
3. What is GARDASIL and what is it used for?
4. What are the ingredients in GARDASIL?
5. Why is vaccination with GARDASIL important?
6. Who should receive GARDASIL?
7. How is GARDASIL given?
8. Will sexually active females benefit from the vaccine?
9. Should girls/women be screened before getting vaccinated?
10. Will girls/women who have been vaccinated still need cervical cancer screening?
11. What are the possible side effects of GARDASIL?
12. Does this vaccine contain thimerosal or mercury?
13. Some girls or women should not get HPV vaccine or should wait
14. What other important information about GARDASIL should I know?
15. Are there other ways to prevent cervical caner?

What are cervical cancer, precancerous lesions, and genital warts?

Cancer of the cervix is a serious and sometimes life-threatening disease. It begins when a female catches certain types of Human Papillomavirus. These types 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.¹ You or your daughter cannot get cervical cancer without first having a Human Papillomavirus infection.²

Worldwide, cervical cancer is the second most common cancer among women, causing 250,000 deaths per year. There are more than 500,000 new cases of cervical cancer diagnosed each year. Genital warts are caused by certain types of Human Papillomavirus. They commonly appear as skin-colored, irregular growths. They are found on the inside or outside of the genitals in both males and females. They can hurt, itch, bleed, and cause discomfort. Sometimes they can come back after treatment.^2,3

What is HPV?

Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States.
There are about 40 types of HPV. About 20 million people in the U.S. are infected, and about 6.2 million more get infected each year. HPV is spread through sexual contact. Most HPV infections don’t cause any symptoms, and go away on their own. But HPV is important mainly because it can cause cervical cancer in women. Every year in the U.S. about 10,000 women get cervical cancer and 3,700 die from it. It is the 2nd leading cause of cancer deaths among women around the world.
HPV is also associated with several less common types of cancer in both men and women. It can also cause genital warts and warts in the upper respiratory tract.
More than 50% of sexually active men and women are infected with HPV at sometime in their lives.
There is no treatment for HPV infection, but the conditions it causes can be treated. ^1,4

What is GARDASIL and what is it used for?

GARDASIL is an inactivated (not live) vaccine that helps protect against the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18.

	Cervical cancer
	Abnormal and precancerous lesions
	Vaginal and vulvar precancerous lesions
	Genital warts

Protection from HPV vaccine is expected to be long-lasting. But vaccinated women still need cervical cancer screening because the vaccine does not protect against all HPV types that cause cervical cancer.
You or your daughter cannot get these diseases from GARDASIL.
GARDASIL helps prevent, but does not treat these diseases.^1,3

What are the ingredients in GARDASIL?

Why is vaccination with GARDASIL important?

In the absence of vaccination, it is estimated that the majority of sexually active people will catch Human Papillomavirus 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. The only way to fully protect yourself from Human Papillomavirus is to avoid this kind of sexual activity. Many people who have Human Papillomavirus may not show any signs or symptoms. This means that they can transmit (pass on) the virus to others without knowing it.^2,4

Who should receive GARDASIL?

Girls or women above 9 years old.⁴

How is GARDASIL given?

GARDASIL is given as an injection.
You or your daughter will receive 3 doses of the vaccine.
Ideally the doses are given as:

	First dose: at a date you and your doctor or health-care provider choose
	Second dose: 2 months after the first dose
	Third dose: 6 months after the first dose

Make sure that you or your daughter gets all 3 doses. This allows you or your daughter to get the full benefits of GARDASIL. If you or your daughter misses a dose, your doctor or health-care provider will decide when to give the missed dose.^1,2

Will sexually active females benefit from the vaccine?

Females who are sexually active may also benefit from the vaccine. But they may get less benefit from the vaccine since they may have already acquired one or more HPV type(s) covered by the vaccine. Few young women are infected with all four of these HPV types. So they would still get protection from those types they have not acquired.^3,4

Should girls/women be screened before getting vaccinated?

No. Girls/women do not need to get an HPV test or Pap test to find out if they should get the vaccine. An HPV test or a Pap test can tell that a woman may have HPV, but these tests cannot tell the specific HPV type(s) that a woman has. Even girls/women with one HPV type could get protection from the other vaccine HPV types they have not yet acquired.^3,4

Will girls/women who have been vaccinated still need cervical cancer screening?

Yes. There are three reasons why women will still need regular cervical cancer screening. First, the vaccine will NOT protect against all types of HPV that cause cervical cancer, so vaccinated women will still be at risk from some cancers. Second, some women may not get all required doses of the vaccine (or they may not get them at the right times), so they may not get the vaccine’s full benefits. Third, women may not get the full benefit of the vaccine if they receive it after they’ve already acquired one of the four HPY types.^3,4

What are the possible side effects of GARDASIL?

Any vaccine may have unintended or undesirable effects, so-called side effects. GARDASIL has been shown to be generally well tolerated. The most commonly reported side effects include injection-site reactions such as pain, swelling, bleeding, itching, and redness, and generalized reactions including fever.⁴ If you or your daughter has any unusual or severe symptoms after receiving GARDASIL, contact your doctor or health-care provider right away.¹

Does this vaccine contain thimerosal or mercury?

No. There is no thimerosal or mercury in the HPV vaccine. It is made up of proteins from the outer coat of the virus (HPV). There is no infectious material in this vaccine.³

Some girls or women should not get HPV vaccine or should wait

	Anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine. Tell your doctor if the person getting the vaccine has any severe allergies.
	Pregnant women should not get the vaccine. The vaccine appears to be safe for both the mother and the unborn baby, but it is still being studied. Receiving HPV vaccine when pregnant is not a reason to consider terminating the pregnancy. Women who are breast feeding may safely get the vaccine.
	People who are mildly ill when the shot is scheduled can still get HPV vaccine. People with moderate or severe illnesses should wait until they recover.^2,3

What other important information about GARDASIL should I know?

There are more than 100 Human Papillomavirus types:
GARDASIL will not protect against all types. Human Papillomavirus Types 6, 11, 16, and 18 have been selected for GARDASIL because they cause over 70% of cervical cancers and 90% of genital warts worldwide.
As with any vaccine, GARDASIL may not fully protect everyone who gets the vaccine. Continue to follow your doctor or health-care provider's instructions on regular Pap tests.
GARDASIL will not protect against diseases that are not caused by HPV.¹

Are there other ways to prevent cervical caner?

Regular Pap tests and follow-up can prevent most, but not all, cases of cervical cancer. Pap tests can detect cell changes in the cervix before they turn into cancer. Pap tests can also detect most, but not all, cervical cancers at an early, curable stage. There is also an HPV DNA test available for use with the Pap test, as part of cervical cancer screening. This test is used for women over 30 or for women who get an unclear (borderline) Pap test result. While this test can tell if a woman has HPV on her cervix, it cannot tell which types of HPV she has.
The only sure way to prevent HPV is to abstain from all sexual activity. Sexually active adults can reduce their risk by being in a mutually faithful relationship with someone who has had no other or few sex partners, or by limiting their number of sex partners. But even persons with only one lifetime sex partner can get HPV, if their partner has had previous partners.
It is not known how much protection condoms provide again HPV, since areas that are not covered by a condom can be exposed to the virus. However, condoms may reduce the risk of genital warts and cervical cancer. They can also reduce the risk of HIV and some other STIs, when used all the time and the right way.^3,4

References:

Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: http://www.fda.gov/cber/products/hpvmer060806qa.htm
World Health Organization. Human papillomavirus infection and cervical cancer. Available at: http://www.who.int/vaccine_research/diseases/hpv/en
HPV Vaccine Questions and Answer. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/std/hpv/hpv-vaccine.pdf
American Cancer Society. Frequently Asked Questions about Human Papilloma Virus (HPV) Vaccines. Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_6x_FAQ_HPV_Vaccines.asp.


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