Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Gardasil

Descriptions


Human papillomavirus (HPV) recombinant quadrivalent vaccine is an active immunizing agent used to prevent infection caused by human papillomavirus (types 6, 11, 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 anal, cervical, vulvar, or vaginal cancer; genital warts; and abnormal or precancerous diseases of the anus, cervix, vagina, and vulva in girls and women 9 to 26 years of age. This vaccine also helps prevent abnormal or precancerous diseases of the anus, anal cancer, and genital warts in boys and men 9 to 26 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 recombinant quadrivalent 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 recombinant quadrivalent 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 this vaccine. It is given as a shot in the muscle of your upper arm or upper leg.

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

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 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 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.

This vaccine does not replace your routine screening tests for anal cancer or cervical cancer (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 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.

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. Black, tarry stools
  2. bleeding gums
  3. blood in urine or stools
  4. blurred vision
  5. body aches or pain
  6. chills
  7. constipation
  8. cough
  9. depressed mood
  10. difficulty with breathing
  11. dry mouth
  12. dry skin and hair
  13. ear congestion
  14. feeling cold
  15. flushed, dry skin
  16. fruit-like breath odor
  17. headache
  18. hoarseness or husky voice
  19. increased hunger
  20. increased thirst
  21. increased urination
  22. loss of consciousness
  23. loss of voice
  24. muscle cramps and stiffness
  25. nasal congestion
  26. nausea
  27. pinpoint red spots on skin
  28. runny nose
  29. slowed heartbeat
  30. sneezing
  31. sore throat
  32. stomachache
  33. sweating
  34. troubled breathing
  35. unexplained weight loss
  36. unusual bleeding or bruising
  37. unusual tiredness or weakness
  38. vomiting

Rare

  1. Difficulty with swallowing
  2. dizziness
  3. fast heartbeat
  4. hives
  5. itching
  6. noisy breathing
  7. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  8. shortness of breath
  9. skin rash
  10. tightness in the chest
  11. wheezing

Incidence not known

  1. Anxiety
  2. back pain, sudden and severe
  3. back, leg, or stomach pains
  4. bloating
  5. chest pain
  6. convulsions (seizures)
  7. dark urine
  8. fainting
  9. general body swelling
  10. hives or welts
  11. hoarseness
  12. inability to move the arms and legs
  13. indigestion
  14. irritation
  15. joint pain, stiffness, or swelling
  16. loss of appetite
  17. loss of bladder control
  18. muscle spasm or jerking of all extremities
  19. muscle weakness, sudden and progressing
  20. nosebleeds
  21. pain in the stomach, side, or abdomen, possibly radiating to the back
  22. pain, redness, or swelling in the arm or leg
  23. pale skin
  24. paralysis
  25. rash
  26. redness of the skin
  27. shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
  28. sudden loss of consciousness
  29. sudden numbness and weakness in the arms and legs
  30. sudden shortness of breath or troubled breathing
  31. swelling of the eyelids, face, lips, hands, or feet
  32. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  33. yellowing of the eyes or skin

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. Red streaks on the skin, swelling, tenderness, pain, or itching at the injection site

Less common

  1. Changes in skin coloring
  2. cloudy urine
  3. diarrhea
  4. difficulty with moving
  5. general feeling of discomfort or illness
  6. hair loss, thinning of hair
  7. muscle pain or stiffness
  8. pain in the joints
  9. sleeplessness
  10. toothache
  11. trouble with sleeping
  12. unable to sleep

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.