human papillomavirus vaccine,9-valent (PF) 0.5 mL IM suspension

Generic name:
Human papillomavirus vaccine - injection

Brand name(s)
Gardasil , Gardasil 9

This medication is a vaccine used to prevent cancer of the anus, abnormal tissue growth of the anus, genital warts, or certain head and neck cancers. In girls and women, it is also used to prevent cancer of the cervix/vagina/vulva and abnormal tissue growth in these areas that can lead to cancer. These conditions are commonly caused by certain types of human papillomavirus (HPV). Vaccines work by increasing the body's natural defense (immunity) against the virus.

This vaccine does not protect against all types of HPV, only the types in the vaccine. It is used to prevent the diseases and will not treat active anal/cervical/head/neck/vaginal/vulvar cancer, genital warts, or other diseases caused by the types of HPV in the vaccine.

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by injection into the muscle of the thigh or upper arm by a health care professional.

This vaccine is usually given as 3 separate doses. The second dose should be given 2 months after the first dose, and the third dose should be given 6 months after the first dose. For children younger than 15 years, this vaccine may also be given as 2 separate doses with the second dose given 6 to 12 months after the first dose. The vaccination schedule should be followed closely for the vaccine to be most effective.

Redness, itching, swelling, bruising, and pain at the injection site may occur. Fever and headache may also occur. If any of these effects last or get worse, tell your health care professional promptly.

Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Seizure-like movements may also rarely happen after injection with this vaccine. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.

Remember that this medication has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.

Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before receiving this vaccine, tell the health care professional if you are allergic to it; or to yeast; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before receiving this vaccination, tell your health care professional your medical history, especially of:

• immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)
• current fever/illness

This vaccine is not recommended for use during pregnancy. Consult your health care professional for more details.

It is unknown if this vaccine passes into breast milk. Consult your health care professional before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this vaccine include:

• drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone)

This vaccine can be given at the same time as other vaccines, using separate injection sites and separate syringes.

Not applicable.

As with any vaccine, this vaccine may not fully protect everyone who receives it.

Getting this vaccine does not replace cervical cancer screening. Continue to have regular obstetrician/gynecologist checkups.

If you miss a dose in the vaccination schedule, contact your health care professional right away.

Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.