Brand Names:

• Gardasil

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Human papillomavirus (HPV) recombinant quadrivalent vaccine is an active immunizing agent used to prevent infection caused by human papillomavirus (types 6, 11, 16, and 18). It works by causing your body to produce its own protection (antibodies) against the virus .

HPV infection is usually a sexually transmitted disease (STD) and is easily spread by having sex with an infected person. This vaccine helps prevent cervical cancer, genital warts, and abnormal or precancerous diseases of the cervix, vagina, and vulva in girls and women 9 to 26 years of age. This vaccine will NOT treat these diseases or protect you against diseases that are caused by other HPV types. The vaccine will also not protect you against other diseases that are not caused by HPV .

This vaccine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of human papillomavirus recombinant quadrivalent vaccine in children younger than 9 years of age. Safety and efficacy have not been established .

Older adults—

Studies on this vaccine have been done only in patients younger than 26 years of age, and there is no specific information comparing use of this vaccine in the elderly with use in other age groups .

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Hemophilia—This vaccine should NOT be used in patients with these conditions .

• Immune deficiency condition, or family history of—This condition may increase the chance and severity of side effects with the vaccine and/or may decrease the useful effects of the vaccine .

• Severe illness with fever—The symptoms of this condition may be confused with the possible side effects of the vaccine .

Proper Use of This Medicine:

To get the best possible protection against infection with HPV types 6, 11, 16, and 18, you should complete the vaccine dosing schedule, even if you are not directly exposed to HPV .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For prevention of HPV infection:
    • Adults and children over 9 years of age—One dose injected into the upper arm or upper leg, followed by a second dose 2 months later, and a third dose 6 months after the first dose.
    • Children below 9 years of age—Use and dose must be determined by your doctor .

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

This vaccine does not replace your routine cervical cancer screening. You will need to see your doctor for screening tests even after receiving this vaccine .

You should tell your doctor if you are pregnant, planning to get pregnant, or breast-feeding before you receive this vaccine .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More Common

Fever

Rare

Cough

difficulty breathing

noisy breathing

shortness of breath

tightness in chest

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Red streaks on skin, swelling, tenderness, pain, or itching at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.