GARDASIL

As a mom, your daughter’s health is one of your top concerns. So it’s no surprise that you may have a few more questions you want answered about GARDASIL and human papillomavirus (HPV). Here are some answers to questions we’ve heard from moms just like you.

Also talk to your daughter’s doctor or healthcare professional for more information about GARDASIL and HPV. In addition, read the Patient Product Information or the Prescribing Information for GARDASIL.

1. How safe is GARDASIL?

2. What are the side effects of GARDASIL?

3. Could my daughter get HPV or any disease caused by HPV from GARDASIL?

4. Have any medical organizations recommended HPV vaccination?

5. Why do I need to vaccinate my daughter now if she is not sexually active?

6. I have daughters aged 11 and 12. Aren’t they too young to be vaccinated with GARDASIL?

7. Does GARDASIL protect against more than cervical cancer?

8. Why should I also help protect my daughter against genital warts?

9. What if I can’t afford GARDASIL?

10. Will my daughter still need to get Pap tests in the future?

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How safe is GARDASIL?

It's no surprise that you want to know more about the safety of GARDASIL before your daughter is vaccinated. The safety of a vaccine is an important part of its story.

The common side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting has been accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity. This may require evaluation or treatment by your daughter's doctor or health care professional.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have reviewed all the safety information available to them. Based on data available to them as of May 2009, the CDC and FDA determined that GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks. In August 2009, the CDC reaffirmed its continued recommendation for vaccination with GARDASIL.

For more information on GARDASIL, talk to your daughter’s doctor or healthcare professional.

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What are the 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, bruising, and redness at the injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting

Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity.

Tell your health care professional 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 professional if you have:

• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness or weakness
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache

Contact your health care professional right away if you get any symptoms that concern you, even several months after getting the vaccine.

The safety of the vaccine is something that is being monitored on an ongoing basis.

For a complete list of GARDASIL side effects, ask your daughter's doctor or health care professional.

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Could my daughter get HPV or any disease caused by HPV from GARDASIL?

No. She cannot get HPV or any disease caused by HPV from GARDASIL. That’s because there is no live virus in the vaccine.

Instead, GARDASIL contains a protein that helps the body’s immune system produce antibodies against HPV—without causing an infection.

For more information on GARDASIL, talk to your daughter’s doctor or healthcare professional.

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Have any medical organizations recommended HPV vaccination?

Yes, a number of national organizations have recommended HPV vaccination. They include:

• American Academy of Pediatrics
• Centers for Disease Control and Prevention (CDC)
• American Academy of Family Physicians
• American College of Obstetricians and Gynecologists

For more information on GARDASIL, talk to your daughter’s doctor or healthcare professional.

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Why do I need to vaccinate my daughter now if she is not sexually active?

It may be hard to think about your daughter even having to worry about coming into contact with HPV. After all, she isn’t sexually active.

But, like other vaccines your daughter may have received, GARDASIL works to help prevent illness. That means GARDASIL works best when given before there is any contact with HPV Types 6, 11, 16, and 18. It’s important to help guard your daughter now, before she’s old enough to be exposed to HPV.

For more information on GARDASIL and HPV, talk to your daughter’s doctor or healthcare professional.

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I have daughters aged 11 and 12. Aren’t they too young to be vaccinated with GARDASIL?

GARDASIL works best when given before there is any contact with HPV Types 6, 11, 16, and 18.

Like other vaccines, GARDASIL works to help prevent illness. That’s why it’s recommended that girls 11 to 12 years of age get vaccinated. HPV vaccination is a part of the recommended vaccination schedule defined by the Centers for Disease Control and Prevention (CDC).

For more information on GARDASIL, talk to your daughter’s doctor or healthcare professional.

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Does GARDASIL protect against more than cervical cancer?

Yes. GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of HPV: 2 types that cause 70% of all cervical cancer cases, and 2 more types that cause 90% of genital warts cases.

By getting your daughter vaccinated with GARDASIL, you’re guarding her against more diseases caused by HPV.

For more information on GARDASIL and HPV, talk to your daughter’s doctor or healthcare professional.

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Why should I also help protect my daughter against genital warts?

It’s simple. You do everything you can to help protect your daughter. There are 1 million new cases of genital warts in men and women in the United States each year. By getting your daughter vaccinated with GARDASIL you’ll help guard her against HPV Types 6 and 11, which cause about 90% of genital warts cases.

For more information on GARDASIL and HPV, talk to your daughter’s doctor or healthcare professional.

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What if I can’t afford GARDASIL?

Merck has created a vaccine patient assistance program for its line of vaccines for use in adults, including GARDASIL. Through this program, Merck provides free vaccines to adults who are 19 and older who are uninsured or unable to afford vaccines.

Additional information regarding the Merck Vaccine Patient Assistance Program can be found at http://www.merck.com/merckhelps/vaccines/home.html.

GARDASIL is also part of the Vaccines for Children program, a federal program that helps to provide free vaccines to children and adolescents 18 years and younger who are either Medicaid eligible, American Indian or Alaskan Native, or uninsured, or whose health insurance does not cover shots.

Additional information regarding the Vaccines for Children program can be found at www.cdc.gov/vaccines/programs/vfcBy clicking on this link, you will be leaving this siteThis link will take you to a site outside of Merck & Co., Inc. Merck does not review or control the content of any non-Merck site. Merck does not endorse and is not responsible for the accuracy, content, practices, or standards of any non-Merck site.
Proceed.

For more information on GARDASIL, talk to your daughter’s doctor or healthcare professional.

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Will my daughter still need to get Pap tests in the future?

Yes. Pap tests (cervical cancer screenings) will play a key role in protecting your daughter’s health as she gets older since GARDASIL does not protect against all types of HPV. Pap tests are proven to help save lives by looking for abnormal cells in the lining of the cervix before they have the chance to become precancers or cancer.

Your daughter’s doctor or healthcare professional can tell you when your daughter’s first Pap test should be. In the meantime, it’s never too early to teach your daughter good healthcare habits.

For more information on GARDASIL and HPV, talk to your daughter’s doctor or healthcare professional.

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IMPORTANT INFORMATION ABOUT GARDASIL

GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases. GARDASIL is for girls and young women ages 9 to 26.

GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts. GARDASIL will not protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL is given as 3 injections over 6 months.

SELECT SAFETY INFORMATION

Anyone who is allergic to the ingredients of GARDASIL, including those severely allergic to yeast, should not receive the vaccine. GARDASIL is not for women who are pregnant.

The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity. Only a doctor or health care professional can decide if GARDASIL is right for you or your daughter.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Read the Patient Product Information or the Prescribing Information for GARDASIL.