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Human papillomavirus vaccine, quadrivalent (Intramuscular route)

Pronunciation:

HUE-man pap-ah-LOH-mah-VYE-rus ree-KOM-bi-nant VAX-een kwa-drah-VAY-lent (types 6,11,16,18)

Brand Names:

  • Gardasil

Dosage Forms:

  • Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

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.

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 recombinant quadrivalent 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 recombinant quadrivalent 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 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 While Using This Medicine:

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 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
Black, tarry stools
bleeding gums
blood in urine or stools
blurred vision
body aches or pain
chills
constipation
cough
depressed mood
difficulty with breathing
dry mouth
dry skin and hair
ear congestion
feeling cold
flushed, dry skin
fruit-like breath odor
headache
hoarseness or husky voice
increased hunger
increased thirst
increased urination
loss of consciousness
loss of voice
muscle cramps and stiffness
nasal congestion
nausea
pinpoint red spots on skin
runny nose
slowed heartbeat
sneezing
sore throat
stomachache
sweating
troubled breathing
unexplained weight loss
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Rare
Difficulty with swallowing
dizziness
fast heartbeat
hives
itching
noisy breathing
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash
tightness in the chest
wheezing
Incidence not known
Anxiety
back pain, sudden and severe
back, leg, or stomach pains
bloating
chest pain
convulsions (seizures)
dark urine
fainting
general body swelling
hives or welts
hoarseness
inability to move the arms and legs
indigestion
irritation
joint pain, stiffness, or swelling
loss of appetite
loss of bladder control
muscle spasm or jerking of all extremities
muscle weakness, sudden and progressing
nosebleeds
pain in the stomach, side, or abdomen, possibly radiating to the back
pain, redness, or swelling in the arm or leg
pale skin
paralysis
rash
redness of the skin
shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
sudden loss of consciousness
sudden numbness and weakness in the arms and legs
sudden shortness of breath or troubled breathing
swelling of the eyelids, face, lips, hands, or feet
swollen, painful, or tender lymph glands in the neck, armpit, or groin
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
Red streaks on the skin, swelling, tenderness, pain, or itching at the injection site
Less common
Changes in skin coloring
cloudy urine
diarrhea
difficulty with moving
general feeling of discomfort or illness
hair loss, thinning of hair
muscle pain or stiffness
pain in the joints
sleeplessness
toothache
trouble with sleeping
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.


Last Updated: 4/4/2014

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