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))

Helps prevents cervical cancer and precancerous diseases caused by human papillomavirus (HPV).

Brand Name(s):

Cervarix

When This Medicine Should Not Be Used:

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 1 month and 6 months later.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This vaccine must 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.

• Some medicines can affect how this vaccine works. Tell your doctor if you are using any of the following:
  • Cancer medicine
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• Tell your doctor if you are receiving radiation treatments.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have an infection or any condition that causes a weak immune system. Tell your doctor if you have a latex allergy.
• This vaccine will not treat cervical cancer, genital warts, or other diseases caused by HPV. It will not protect you against diseases caused by all HPV types. This vaccine will not protect you against sexually transmitted diseases that are not caused by HPV.
• You will need to see your doctor for screening tests (such as pap tests) even after you receive this vaccine.
• This vaccine may cause you to feel faint, lightheaded, or dizzy right after you receive it. It may help to sit or lie down for 15 minutes after you receive the vaccine. Do not drive or do anything else that could be dangerous if you feel dizzy.

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
• Lightheadedness, dizziness, or fainting

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
• Tiredness

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