Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Cervarix

Descriptions


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.

This product is available in the following dosage forms:

  • Suspension

Before Using

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

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.

Geriatric

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.

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.

Proper Use

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

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

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

  1. Fever

Less common

  1. Bladder pain
  2. bloody or cloudy urine
  3. body aches or pain
  4. change in the color, amount, or odor of vaginal discharge
  5. chills
  6. cough
  7. diarrhea
  8. difficult, burning, or painful urination
  9. difficulty with breathing
  10. ear congestion
  11. frequent urge to urinate
  12. general feeling of discomfort or illness
  13. headache
  14. joint pain
  15. loss of appetite
  16. loss of voice
  17. lower back or side pain
  18. muscle aches and pains
  19. nasal congestion
  20. nausea
  21. runny nose
  22. shivering
  23. sneezing
  24. sore throat
  25. sweating
  26. trouble with sleeping
  27. unusual tiredness or weakness
  28. vomiting

Incidence not known

  1. Blistering, peeling, or loosening of the skin
  2. difficulty with swallowing
  3. dizziness
  4. fainting
  5. fast heartbeat
  6. hives
  7. itching
  8. joint or muscle pain
  9. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  10. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  11. red, irritated eyes
  12. shortness of breath
  13. skin rash
  14. sores, ulcers, or white spots in the mouth or on the lips
  15. tightness in the chest
  16. 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

  1. Abdominal or stomach cramps, discomfort, or pain
  2. back pain
  3. constipation
  4. difficulty with moving
  5. hives or welts
  6. indigestion
  7. red streaks on the skin
  8. redness of the skin
  9. swelling, tenderness, or pain at the injection site
  10. swollen joints
  11. swollen mouth and tongue
  12. unpleasant taste
  13. urge to have bowel movement

Less common

  1. Congestion
  2. heavy bleeding
  3. hoarseness
  4. pain
  5. stuffy or runny nose
  6. tender, swollen glands in the neck
  7. trouble with swallowing
  8. voice changes

Rare

  1. Changes in menstrual periods
  2. decreased sexual ability in males
  3. depressed mood
  4. dry skin and hair
  5. dry, puffy skin
  6. feeling cold
  7. hair loss
  8. nervousness
  9. rectal bleeding
  10. red, scaling, or crusted skin
  11. sensitivity to heat
  12. severe abdominal or stomach pain
  13. severe diarrhea
  14. slowed heartbeat
  15. sweating
  16. swelling of the front part of the neck
  17. weight gain
  18. 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.