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Gardasil

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Gardasil

PATIENT INFORMATION

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ®
(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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . You (the person getting GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .

What is GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ?

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) cannot protect you from a disease that is caused by other types of HPV, other viruses, or bacteria.
    • GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) does not treat HPV infection.
    • You cannot get HPV or any of the above diseases from GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) is used for boys and men 9 through 26 years of age to help protect against genital warts.

What important information about GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) should I know?

  • You should continue to get routine cervical cancer screening.
  • GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) may not fully protect everyone who gets the vaccine.
  • GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) will not protect against HPV types that you already have.

Who should not get GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ?

You should not get GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) if you have, or have had:

  • an allergic reaction after getting a dose of GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .
  • a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

What should I tell my health care provider before getting GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ?

Tell your health care provider if you:

  • are pregnant or planning to get pregnant. GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .
  • 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) given?

GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) ?

The most common side effects with GARDASIL (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) are:

  • pain, swelling, itching, bruising, and redness at the injection site
  • headache
  • fever
  • nausea
  • dizziness
  • vomiting
  • fainting

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)
  • joint pain
  • unusual tiredness, weakness, or confusion
  • chills
  • generally feeling unwell
  • leg 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 (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) . If you would like more information, please talk to your health care provider or visit www.gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) .com.

Last reviewed on RxList: 1/26/2010
This monograph has been modified to include the generic and brand name in many instances.

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