Patient Information about GARDASIL®

Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Read this information with care before you or your child gets GARDASIL*. You or your child will need 3 doses of the vaccine. It is important to read this leaflet when you receive each dose. This leaflet does not take the place of talking with your health care professional about GARDASIL.

What is GARDASIL and what is it used for?

GARDASIL is a vaccine (injection/shot) that helps protect against the following diseases caused by
Human Papillomavirus (HPV) Types in the vaccine (6, 11, 16, and 18):

  • Cervical cancer (cancer of the lower end of the uterus or womb).
  • Abnormal and precancerous cervical lesions.
  • Abnormal and precancerous vaginal lesions.
  • Abnormal and precancerous vulvar lesions.
  • Genital warts.

GARDASIL helps prevent these diseases – but it will not treat them. You or your child cannot get these diseases from GARDASIL.

What other key information about GARDASIL should I know?

  • Vaccination does not substitute for routine cervical cancer screening. Females who receive GARDASIL should continue cervical cancer screening.
  • As with all vaccines, GARDASIL may not fully protect everyone who gets the vaccine.
  • Gardasil will not protect against diseases due to non-vaccine HPV types. There are more than 100 HPV types; GARDASIL helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for GARDASIL because they cause approximately 70% of cervical cancers and 90% of genital warts.
  • This vaccine will not protect you against HPV types to which you may have already been exposed.
  • GARDASIL also will not protect against other diseases that are not caused by HPV.
  • GARDASIL works best when given before you or your child has any contact with certain types of
  • HPV (i.e., HPV types 6, 11, 16, and 18).

Who can receive GARDASIL?

GARDASIL is for girls and women 9 through 26 years of age.
See “Who should not receive GARDASIL?” below.

Who should NOT receive GARDASIL?

Anyone who:

  • is aklergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
  • has an allergic reaction after getting a dose of the vaccine.

What should I tell my health care professional before I am vaccinated or my child is vaccinated with GARDASIL?

[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 96823052

It is very important to tell your health care professional if you or your child:

  • has had an allergic reaction to the vaccine.
  • has a bleeding disorder and cannot receive injections in the arm.
  • has a weakened immune system, for example, due to a genetic defect or HIV infection.
  • is pregnant or is planning to get pregnant. GARDASIL is not recommended for use in pregnant women.
  • has any illness with a fever more than 100°F (37.8°C).
  • takes or plans to take any medicines, even those you can buy over the counter.

Your health care professional will decide if you or your child should receive the vaccine.

How is GARDASIL given?

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

  • First dose: at a date you and your health care professional choose.
  • Second dose: 2 months after the first dose.