Pronunciation:

HUE-man pap-ah-LOH-mah-VYE-rus ree-KOM-bi-nant VAX-een bye-VAY-lent (types 16, 18)

Brand Names:

• Cervarix

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Human papillomavirus (HPV) recombinant bivalent vaccine is an active immunizing agent (vaccine) that is used to prevent infection caused by human papillomavirus (types 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 and abnormal or precancerous diseases of the cervix in girls and women 9 to 25 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.

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 bivalent vaccine in children younger than 9 years of age. Safety and efficacy have not been established.

Older adults—

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

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	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.

Breast-feeding—

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.

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:

• 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:

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.

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 1 month and 6 months after the first dose, unless your doctor tells you otherwise.

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.

Precautions While Using This Medicine:

It is very important that you or your child 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 or your child 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.

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 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.

The needle cover of the prefilled syringe contains 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 have a latex allergy 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 or nurse immediately if any of the following side effects occur:

More common

Fever

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

change in the color, amount, or odor of vaginal discharge

chills

cough

diarrhea

difficult, burning, or painful urination

difficulty with breathing

ear congestion

frequent urge to urinate

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nasal congestion

nausea

runny nose

shivering

sneezing

sore throat

sweating

trouble with sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

difficulty with swallowing

dizziness

fainting

fast heartbeat

hives

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red, irritated eyes

shortness of breath

skin rash

sores, ulcers, or white spots in the mouth or on the lips

tightness in the 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

Abdominal or stomach cramps, discomfort, or pain

back pain

constipation

difficulty with moving

hives or welts

indigestion

red streaks on the skin

redness of the skin

swelling, tenderness, or pain at the injection site

swollen joints

swollen mouth and tongue

unpleasant taste

urge to have bowel movement

Less common

Congestion

heavy bleeding

hoarseness

pain

stuffy or runny nose

tender, swollen glands in the neck

trouble with swallowing

voice changes

Rare

Changes in menstrual periods

decreased sexual ability in males

depressed mood

dry skin and hair

dry, puffy skin

feeling cold

hair loss

nervousness

rectal bleeding

red, scaling, or crusted skin

sensitivity to heat

severe abdominal or stomach pain

severe diarrhea

slowed heartbeat

sweating

swelling of the front part of the neck

weight gain

weight loss

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.