Gardasil



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Generic Name: human papillomavirus (HPV) vaccine
(HYOO man pap il OH ma VI rus vax EEN)

What is Gardasil vaccine?

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

HPV vaccine is used to preventgenital warts and cervical/vaginal cancers caused by certain types of HPV (types 6, 11, 16, and 18) in girls and young women.

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.

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 treatactive 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 is the most important information I should know about Gardasil vaccine?

Before receiving HPV 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.

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 treatactive genital warts or HPV-related cancers, and it will not cure HPV infection.

You may feel faint after receiving this vaccine, especially within the first 15 minutes after injection.

Becoming infected with 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 should I discuss with my health care provider before receiving Gardasil vaccine?

Before receiving HPV 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. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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 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 Gardasil 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 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 by the health department of the state you live in. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

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 Gardasil 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 Gardasil vaccine?

Becoming infected with 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.

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.

You may feel faint after receiving this vaccine, especially within the first 15 minutes after injection.

Other side effects may include:

  • pain, swelling, redness, or itching where the shot was given
  • mild fever
  • nausea, vomiting, diarrhea, upset stomach
  • dizziness, tired feeling
  • runny or stuffy nose, sore throat, cough; or
  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gardasil vaccine?

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
  • 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 there may be other drugs that can interact with this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.