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human papillomavirus (HPV) vaccine, quadrivalent

Pronunciation: HYOO man pap il OH ma VI rus vax EEN, kwa dri VAY lent

Brand: Gardasil

What is the most important information I should know about human papillomavirus vaccine?

The quadrivalent (kwa-dri-VAY-lent) form of HPV vaccine (Gardasil) is used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females. This medication guide provides information only for Gardasil.

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You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Before receiving HPV quadrivalent vaccine, tell your doctor if you have a high fever or signs of infection, a weak immune system, a bleeding disorder such as hemophilia, or if you are taking a blood thinner such as warfarin (Coumadin).

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.

HPV vaccine should not be used in place of having a routine pelvic exam and Pap smear to screen for cervical cancer.

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You may receive this vaccine even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

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You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

HPV vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

What is human papillomavirus vaccine?

Human papillomavirus (HPV) can cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina.

The quadrivalent (kwa-dri-VAY-lent) form of HPV vaccine (Gardasil) is used in both females and males. Another form of HPV vaccine (Cervarix) is used only in females. This medication guide provides information only for Gardasil.

HPV quadrivalent vaccine (Gardasil) is used to prevent genital warts and cervical/vaginal/anal cancers caused by certain types of HPV (types 6, 11, 16, and 18) in girls and young women ages 9 through 26.

HPV quadrivalent vaccine is also used to prevent genital warts caused by HPV types 6 and 11 in boys and young men ages 9 through 26.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all girls ages 11 or 12 years old. The vaccine is also recommended in girls and women ages 13 through 26 years old who have not already received the vaccine or have not completed all booster shots.

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You may receive this vaccine even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

HPV vaccine may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before receiving human papillomavirus vaccine?

Before receiving this vaccine, tell your doctor if you have:

  • high fever, or signs of infection;
  • a weak immune system;
  • a bleeding or blood-clotting disorder, such as hemophilia; or
  • if you are taking a blood thinner such as warfarin (Coumadin).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. However, you should not receive HPV vaccine without telling your doctor if you are pregnant or plan to become pregnant before you have received all doses of this vaccine.

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It is not known whether HPV vaccine passes into breast milk or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

HPV vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

HPV quadrivalent vaccine will not prevent diseases caused by HPV types other than types 6, 11, 16, and 18. There are over 100 different types of HPV.

How is human papillomavirus vaccine given?

HPV vaccine is given as an injection (shot) into a muscle in your upper arm or thigh. You will receive this injection in a doctor's office or other clinic setting.

HPV quadrivalent vaccine is given in a series of 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 26 years old. Then you will need to receive a second dose 2 months after your first shot, and a third dose 6 months after your first shot.

Be sure to receive all doses of this vaccine recommended by your healthcare provider or your state's health department. You may not be fully protected if you do not receive the full series.

HPV vaccine should not be used in place of having a routine pelvic exam and Pap smear to screen for cervical cancer.

What happens if I miss a dose?

Contact your doctor if you will miss an HPV vaccine booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid while receiving human papillomavirus vaccine?

There may be certain other vaccines that should not be given at the same time as the HPV vaccine. Until you have completed the series of 3 HPV vaccines, do not receive any other vaccine (including a flu shot) without first asking your doctor.

What are the possible side effects of human papillomavirus vaccine?

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You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

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Call your doctor at once if you have a serious side effect such as:

  • severe stomach pain;
  • swollen glands;
  • easy bruising or bleeding, confusion, unusual weakness;
  • fever, chills, body aches, general ill feeling;
  • chest pain; or
  • feeling short of breath.

Less serious side effects may include:

  • pain, swelling, redness, bruising, or itching where the shot was given;
  • mild fever, headache, dizziness, tired feeling;
  • nausea, vomiting, diarrhea;
  • sleep problems (insomnia);
  • runny or stuffy nose, sore throat, cough; or
  • tooth pain, joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect human papillomavirus vaccine?

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Before receiving the HPV vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • chemotherapy or radiation;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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