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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.