Cervarix

Human papillomavirus (HPV) vaccine is an active immunizing agent used to prevent infection caused by human papillomavirus. 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:

• Anal, cervical, vulvar, or vaginal cancer
• Genital warts
• Abnormal or precancerous diseases of the anus, cervix, vagina, and vulva

in girls and women 9 to 26 years of age.

This vaccine also helps prevent abnormal or precancerous diseases of the anus, anal cancer, and 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

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 Population

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

Geriatric Population

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

Pregnancy

All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 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.

A nurse or other trained health professional will give you or your child 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 or your child's dosing schedule will be specific to the brand of HPV vaccine.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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.

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 has

• a rash,
• itching,
• swelling of the tongue and throat,
• trouble with breathing

after you get the injection.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

This vaccine does not replace your routine screening tests for anal cancer or cervical cancer (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 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.

The needle cover of the prefilled syringe may contain dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child has a latex allergy before you receive this vaccine.

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

Less common

• Fever

Incidence not known

• Anxiety
• back, leg, or stomach pains
• bleeding gums
• chest pain
• chills
• cough
• dark urine
• difficulty with breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast heartbeat
• general body swelling
• headache
• hives or welts, itching, or skin rash
• loss of appetite
• nausea or vomiting
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• seizures
• sore throat
• sudden shortness of breath or troubled breathing
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• tightness in the chest
• unusual tiredness or weakness
• 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

• Headache

Less common

• Diarrhea
• difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• sore throat
• swollen joints
• upper abdominal or stomach pain

Rare

• Body aches or pain
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing

Incidence not known

• Bloating
• constipation
• darkened urine
• difficulty with moving
• fast heartbeat
• indigestion
• loss of appetite
• muscle pain or stiffness
• pain in the joints pain, swelling, or redness at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back

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.