Skip to main content

Human papillomavirus vaccine, bivalent (Intramuscular route)

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.

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.


Last Updated: 4/4/2014

Copyright © 1984- Thomson Micromedex. All rights reserved.

Thomson & A.D.A.M