Gardasil

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, vulvar, or vaginal 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 also helps prevent genital warts in boys and men 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 sexually transmitted diseases that are not caused by HPV.

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

This product is available in the following dosage forms:

• Suspension

Before Using

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.

Pediatric

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.

Geriatric

Appropriate studies on the relationship of age to the effects of human papillomavirus recombinant quadrivalent vaccine have not been performed in the geriatric population. Safety and efficacy have not been established.

Drug Interactions

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:

• Immune deficiency condition, or family history ofa€”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 fevera€”The symptoms of this condition may be confused with the possible side effects of the vaccine .

Proper Use

A nurse or other trained health professional will give you this vaccine . It is given as a shot in the muscle of your upper arm or upper leg.

To get the best possible protection against infection with the HPV virus, you should complete the vaccine dosing schedule, even if you are not directly exposed to HPV.

This vaccine is usually given as three shots. You will need another dose at 2 months and 6 months after the first dose, unless your doctor tells you otherwise.

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

It is very important that you return to your doctor`s office at the right time for all of the doses. Be sure to notify your doctor of any side effects that occur after you receive this vaccine .

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble with breathing after you get the injection .

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

You or your child may feel faint, lightheaded, or dizzy right after you receive this vaccine . Sitting or lying down for 15 minutes after you receive the vaccine may also help. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert. If this problem continues or gets worse, check with your doctor .

Side Effects

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 or nurse immediately if any of the following side effects occur:

More common

• Fever

Less common

• Body aches or pain


• Chills


• Cough


• Difficulty with breathing


• Ear congestion


• Headache


• Loss of voice


• Nasal congestion


• Runny nose


• Sneezing


• Sore throat


• Unusual tiredness or weakness

Rare

• Difficulty with swallowing


• Dizziness


• Fast heartbeat


• Hives


• Itching


• Noisy breathing


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Shortness of breath


• Skin rash


• Tightness in the chest


• Wheezing

Incidence not known

• Anxiety


• Back pain, sudden and severe


• Back, leg, or stomach pains


• Bleeding gums


• Bloating


• Chest pain


• Constipation


• Convulsions


• Dark urine


• Fainting


• Fatigue


• General body swelling


• Hives or welts


• Hoarseness


• Inability to move the arms and legs


• Indigestion


• Irritation


• Joint pain, stiffness, or swelling


• Loss of appetite


• Loss of bladder control


• Muscle spasm or jerking of all extremities


• Muscle weakness, sudden and progressing


• Nausea or vomiting


• Nosebleeds


• Pain in the stomach, side, or abdomen, possibly radiating to the back


• Pain, redness, or swelling in the arm or leg


• Pale skin


• Paralysis


• Rash


• Redness of the skin


• Shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination


• Sudden loss of consciousness


• Sudden numbness and weakness in the arms and legs


• Sudden shortness of breath or troubled breathing


• Swelling of the eyelids, face, lips, hands, or feet


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin


• Yellowing of the eyes or skin

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 the skin, swelling, tenderness, pain, or itching at the injection site

Less common

• Diarrhea


• Difficulty with moving


• General feeling of discomfort or illness


• Muscle pain or stiffness


• Pain in the joints


• Sleeplessness


• Toothache


• Trouble with sleeping


• Unable to sleep

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.