Pronunciation:

HUE-man pap-ah-LOH-mah-VYE-rus VAX-een

Brand Names:

• Cervarix
• Gardasil
• Gardasil 9

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Human papillomavirus (HPV) vaccine helps prevent anal, cervical, vulvar, vaginal, oropharyngeal (mouth and throat), or head and neck cancer, genital warts, and abnormal or precancerous diseases of the anus, cervix, vagina, and vulva in girls and women 9 to 45 years of age.

This vaccine also helps prevent anal, oropharyngeal (mouth and throat), or head and neck cancer, genital warts, and abnormal or precancerous diseases of the anus in boys and men 9 to 45 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 not protect you against other sexually transmitted diseases that are not caused by HPV.

Human papillomavirus (HPV) vaccine is an active immunizing agent used to prevent infection caused by human papillomavirus. 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 is to be given only by or under the direct supervision of your doctor.

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 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 vaccine have not been performed in the geriatric population. Safety and efficacy have not been established.

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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Teplizumab-mzwv
• Ublituximab-xiiy

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:

• Allergy to yeast, history of—Should not be used in patients with this condition.

• Immune deficiency condition, or family history of—This condition may increase the chance and severity of side effects with the vaccine 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 or your child this vaccine. It is given as a shot in the muscle of your upper arm or upper leg.

Your doctor may want you to stay for at least 15 minutes after receiving a shot of Gardasil® 9 to check for unwanted effects.

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 2 or 3 shots based on the brand and your age. You or your child's dosing schedule will be specific to the brand of HPV vaccine.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Read it again each time you receive a shot in case there is new information. Ask your doctor if you have any questions.

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 may occur after you receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has 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 or do anything else that could be dangerous until you know how this medicine affects you. If this problem continues or gets worse, check with your doctor.

The needle cover of the Cervarix® prefilled syringe may contain 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 has a latex allergy before you receive this vaccine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Less common

Fever

Incidence not known

Anxiety

back, leg, or stomach pains

bleeding gums

chest pain

chills

cough

dark urine

difficulty with breathing

difficulty with swallowing

dizziness or lightheadedness

fainting

fast heartbeat

general body swelling

headache

hives or welts, itching, or skin rash

loss of appetite

nausea

nosebleeds

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

sore throat

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

tightness in the chest

unusual tiredness or weakness

vomiting

yellow 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

Pain, redness, itching, or swelling at the injection site

Less common

Bleeding, bruising, or lumps at the injection site

diarrhea

difficulty with moving

joint pain or swelling

muscle ache, cramps, pain, or stiffness

upper abdominal or stomach pain

Rare

Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, numbness, rash, redness, scarring, soreness, stinging, tenderness, tingling, ulceration, or warmth at the injection site

body aches or pain

ear congestion

loss of voice

sneezing

stuffy or runny nose

Incidence not known

Bloating

constipation

dark urine

difficulty with moving

indigestion

pains in the stomach, side, or abdomen, possibly radiating to the back

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.