Human papillomavirus (HPV) is a sexually transmitted disease that can cause genital warts. HPV can also cause anal cancer or various cancers of the cervix, vagina, vulva, oropharynx (the middle part of the throat), or head and neck.

HPV 9-valent vaccine is used in children and adults ages 9 through 45 years to prevent genital warts or cancers caused by certain types of HPV.

You may receive this vaccine even if you have already had genital warts, or had a positive HPV test or abnormal pap smear in the past. However, this vaccine will not treat active genital warts or HPV-related cancers, and it will not cure HPV infection.

HPV 9-valent vaccine prevents diseases caused only by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It will not prevent diseases caused by other types of HPV.

The Centers for Disease Control and Prevention (CDC) recommends HPV vaccine for all boys and girls ages 11 or 12 years old. The vaccine is also recommended in teenage boys and girls who have not already received the vaccine or have not completed all booster shots.

Like any vaccine, the HPV 9-valent vaccine may not provide protection from disease in every person.

HPV 9-valent vaccine may also be used for other purposes not listed in this medication guide.

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

You may feel faint during the first 15 minutes after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine.

HPV 9-valent vaccine is given as an injection (shot) into a muscle in your upper arm or thigh. A healthcare provider will give you this injection.

HPV 9-valent vaccine is given in a series of 2 or 3 shots. You may have the first shot at any time as long as you are between the ages of 9 and 45 years old. The second dose is given 2 to 12 months after your first shot. A third dose may be given 6 months after your first shot.

Be sure to receive all recommended doses of this vaccine or you may not be fully protected against disease.

HPV 9-valent vaccine should not be used in place of having a routine pelvic exam, Pap smear, anal, or head and neck exam to screen for cervical, anal, or head and neck cancer.

Usual Adult Dose for Human Papillomavirus Prophylaxis:

Cervarix(R):
Females, up to 25 years old: 0.5 mL, intramuscularly, at 0, 1, and 6 months

Gardasil(R):
Females and males, up to 26 years: 0.5 mL, intramuscularly, at 0, 2, and 6 months

Gardasil 9(R):
Females and males, up to 45 years: 0.5 mL, intramuscularly, at 0, 2, and 6 months

Uses: For the prevention of cervical, vulvar, and anal cancer caused by Human Papillomavirus (HPV) in females, and prevention of anal cancer, genital warts, and anal intraepithelial neoplasia cause by HPV in males.

Usual Pediatric Dose for Human Papillomavirus Prophylaxis:

Cervarix(R):
Females, aged 9 to 25 years: 0.5 mL, intramuscularly, at 0, 1, and 6 months

Gardasil(R):
Females and males, aged 9 to 26 years: 0.5 mL, intramuscularly, at 0, 2, and 6 months

Gardasil 9(R):
Females and males, aged 9 to 14 years: 0.5 mL, intramuscularly, at 0, and 6 to 12 months (2 dose regimen)
OR
Females and males, aged 9 to 14 years: 0.5 mL, intramuscularly, at 0, 2, and 6 months (3 dose regimen)

Females and males, aged 15 to 45 years: 0.5 mL, intramuscularly, at 0, 2, and 6 months

Comments:
-For patients aged 9 to 14: If the second Gardasil 9(R) dose is given earlier than 5 months after the first dose, administer a third dose at least 4 months after the second.


Uses: For the prevention of cervical, vulvar, and anal cancer caused by Human Papillomavirus (HPV) in females, and prevention of anal cancer, genital warts, and anal intraepithelial neoplasia cause by HPV in males.

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot. You may not be able to receive this vaccine if you have a high fever.

HPV 9-valent vaccine will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.

Tell your doctor if you have ever had:

• an allergy to yeast, polysorbate 80, or to other vaccines;

• a weak immune system (caused by conditions such as HIV or cancer); or

• treatment with cancer medicine, steroids, or other drugs that can weaken your immune system.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of HPV 9-valent vaccine on the baby.

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

An overdose of this vaccine is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

You may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Developing cancer from HPV is much more dangerous to your health than receiving the vaccine to protect against it. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Common side effects of human papillomavirus (HPV) vaccine, 9-valent may include:

• pain, swelling, redness, itching, bruising, bleeding, and a lump where the shot was given;

• nausea, diarrhea, stomach pain;

• headache;

• fever;

• sore throat;

• dizziness; or

• tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Your vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.