This medication belongs to the family of medications known as vaccines. It is used to prevent cervical cancer and certain precancerous lesions of the cervix caused by infection with the human papillomavirus (HPV types 16, and 18) in girls and women 9 to 45 years of age. The HPV vaccine works by helping the immune system protect against an HPV infection.

HPV infections are sexually transmitted. The HPV vaccine does not help prevent other types of sexually transmitted infections (STIs).

HPV types 16 and 18 are responsible for approximately 70% of all cervical cancer cases. Cervical cancer can be caused by other HPV types. The human papillomavirus bivalent vaccine does not protect against all cancers or other diseases caused by these or other types of HPV.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop receiving this medication without consulting your doctor.

This medication is given as 3 separate 0.5 mL injections into the upper arm muscle. The second dose is usually given 1 month after the first dose, and the third dose is usually given 6 months after the first dose. If needed, the vaccination schedule can be more flexible with the second dose given between 1 month and 2.5 months after the first dose and the third dose given 5 months to 12 months after the second one. The injections are given by a health care professional in a clinic or similar setting.

For girls 9 to 14 years of age, your doctor may choose to give a 2 dose vaccination schedule instead. The medication is given as 2 separate 0.5 mL injections into the upper arm muscle. The second dose is usually given 6 months after the first dose. If needed, the vaccination schedule can be more flexible with the second dose given between 5 and 7 months after the first dose.

It is important to receive this medication exactly as recommended by your doctor. If you miss an appointment to receive a dose, contact your doctor as soon as possible to reschedule your appointment. If you do not receive all three vaccinations, your protection against cervical cancer may be reduced.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

This medication is stored in the refrigerator and should not be allowed to freeze. It should be protected from light and kept out of the reach of children.

Each 0.5 mL dose of sterile preparation for intramuscular administration contains approximately 20 µg HPV type 16 L1 protein and 20 µg HPV type 18 L1 protein. Nonmedicinal ingredients: 3-0-desacyl-4'- monophosphoryl lipid A (MPL), aluminum hydroxide, sodium chloride, sodium dihydrogen phosphate dihydrate, and sterile water for injection.

Do not take this medication if you are allergic to HPV bivalent vaccine or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• a general feeling of discomfort or illness
• abdominal pain
• aching muscles, muscle tenderness, or weakness (not caused by exercise)
• diarrhea
• dizziness
• fever
• headache
• joint pain
• nausea
• pain, swelling, itching, or redness at the place of injection
• tiredness
• vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a severe allergic reaction (e.g., itching, rash, hives, swelling of the face or lips, chest tightness, shortness of breath, or wheezing)
• fainting that may be accompanied by shaking or stiffness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding disorders: If you have any bleeding problems (such as hemophilia) or are taking blood thinners, such as warfarin, tell your doctor before receiving this medication.

Fainting: People receiving vaccines may faint. Tell your doctor if you have previously fainted while receiving an injection. It is recommended to wait in your doctor's office for 15 minutes after receiving the vaccine.

Fever: Your doctor may decide to delay vaccination if you have a severe fever or infection. You can still receive the vaccine if you have a minor infection such as a cold.

Health exams: You will still need to have regular health exams after having the vaccine, including Pap tests, HPV DNA tests, or other tests as recommended by your doctor.

Immune system: People with weakened immune systems (e.g., those with cancer, HIV, or taking immunosuppressive therapy) may not get the full benefits of the vaccine.

Vaccine protection: This vaccine protects only against certain types of HPV and, as with other vaccines, may not provide 100% protection for everyone who receives the vaccine. The HPV vaccine should not be used for treatment of active genital warts or cervical and vaginal cancers. It does not prevent any other STIs, such as chlamydia, gonorrhea, or HIV. Condoms should still be used to prevent STIs even after you have received the vaccine. The vaccine should not be a substitute for regular cervical screening (i.e., Pap tests).

Pregnancy: This medication is not recommended during pregnancy. If you become pregnant while receiving this medication, contact your doctor immediately. It is also recommended to avoid becoming pregnant for 2 months after vaccination with human papillomavirus bivalent vaccine.

Breast-feeding: It is not known if HPV vaccine passes into breast milk. If you are a breast-feeding mother and are receiving this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children under 9 years of age.

Adults older than 25 years: The safety and efficacy of this medication have not been established for adults over 25 years of age.

There may be an interaction between human papillomavirus bivalent vaccine and any of the following:

• certain other vaccines
• immunosuppressive therapy medications that weaken the immune system (e.g., certain cancer medications, transplant medications)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.