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Human papillomavirus vaccine, bivalent (Injection)

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

Prevents cancer and abnormal or precancerous diseases of the cervix caused by 2 specific types of human papillomavirus (HPV), in girls and women 10 to 25 years of age.

Brand Name(s):

Cervarix

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

You should not receive this vaccine if you have had an allergic reaction to human papillomavirus vaccine.

How to Use This Medicine:

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
  • A nurse or other health provider will give you this medicine.
  • This vaccine must be given as 3 doses. After the first dose, two more doses are given at 1 month and 6 months later, unless your doctor tells you otherwise.

If a dose is missed:

  • This vaccine needs to be given on a fixed schedule. If you miss your scheduled shot, call your doctor to make another appointment as soon as possible.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you are receiving a treatment or using a medicine that causes a weak immune system. This may include radiation treatment, steroid medicines (such as cortisone, dexamethasone, prednisone, Cortef®, or Medrol®), or cancer medicines (such as cyclophosphamide, doxorubicin, etoposide, Adriamycin®, or Cytoxan®).

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have a weak immune system because of a disease (such as HIV infection or a genetic defect) or a medicine (such as steroids). Tell your doctor if you or your child have an active infection that is causing fever or chills.
  • This vaccine will not treat cervical cancer, genital warts, or other diseases caused by HPV. It will not protect you against diseases that are caused by HPV types that are not in the vaccine. This vaccine will not protect you against sexually transmitted diseases that are not caused by HPV.
  • 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. 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.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Fever, chills, runny or stuffy nose, cough, sore throat, and body aches.
  • Lightheadedness, dizziness, or fainting.
  • Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

  • Diarrhea, nausea, vomiting, or stomach pain.
  • Headache.
  • Joint or muscle pain.
  • Pain, redness, itching, burning, swelling, or a lump under your skin where the shot is given.
  • Rash or itching skin.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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


Last Updated: 9/4/2014


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