Gardasil 9 Vaccine

What is Gardasil 9 Vaccine?

Gardasil 9 is a vaccine (injection/shot) given to individuals 9 through 45 years of age to help protect against diseases caused by some types of Human Papillomavirus (HPV).

What diseases can Gardasil 9 help protect against?

In girls and women 9 through 45 years of age, Gardasil 9 helps protect against:

• Cervical cancer
• Vulvar and vaginal cancers
• Anal cancer
• Certain head and neck cancers, such as throat and back of mouth cancers
• Precancerous cervical, vulvar, vaginal and anal lesions
• Genital warts

In boys and men 9 through 45 years of age, Gardasil 9 helps protect against:

• Anal cancer
• Certain head and neck cancers, such as throat and back of mouth cancers
• Precancerous anal lesions
• Genital warts

These diseases may have many causes, including HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Gardasil 9 only protects against diseases caused by these nine types of HPV.

People cannot get HPV or any of these diseases from Gardasil 9.

What is the most important information I should know about Gardasil 9 Vaccine?

Gardasil 9:

• Does not remove the need for screening for cervical, vulvar, vaginal, anal, and certain head and neck cancers, such as throat and back of mouth cancers as recommended by a health care professional; women should still get routine cervical cancer screening.
• Does not protect the person getting Gardasil 9 from a disease that is caused by other types of HPV, other viruses or bacteria.
• Does not treat HPV infection.
• Does not protect the person getting Gardasil 9 from HPV types that he/she may already have.

Gardasil 9 may not fully protect each person who gets it.

Who should not take Gardasil 9 Vaccine?

Anyone with an allergic reaction to:

• A previous dose of Gardasil 9
• A previous dose of Gardasil
• Yeast (severe allergic reaction)
• Amorphous aluminum hydroxyphosphate sulfate
• Polysorbate 80

What should I tell my healthcare provider before taking Gardasil 9 Vaccine?

Tell the health care professional if you or your child (the person getting Gardasil 9):

• Are pregnant or planning to get pregnant.
• Have immune problems, like HIV or cancer.
• Take medicines that affect the immune system.
• Have a fever over 100°F (37.8°C).
• Might have had an allergic reaction to a previous dose of Gardasil 9 or Gardasil.
• Take any medicines, even those you can buy over the counter.

The health care professional will help decide if you or your child should get the vaccine.

How should I take Gardasil 9 Vaccine?

Gardasil 9 is a shot that is usually given in the arm muscle. Gardasil 9 may be given as 2 or 3 shots.

* If the second shot is given earlier than 5 months after the first shot, you will need to get a third shot at least 4 months after the second shot was given.

† The need to use a 3-dose schedule instead of a 2-dose schedule will be determined by your health care professional.

Make sure that you or your child gets all doses recommended by your health care professional so that you or your child gets the best protection. If the person getting Gardasil 9 misses a dose, tell the health care professional and they will decide when to give the missed dose. It is important that you follow the instructions of your health care professional regarding return visits for the follow-up doses.

Fainting can happen after getting an HPV vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, the health care professional may ask the person getting Gardasil 9 to sit or lie down for 15 minutes after getting the vaccine. Some people who faint might shake or become stiff. The health care professional may need to treat the person getting Gardasil 9.

Can I get Gardasil 9 if I have already gotten Gardasil?

If you have already gotten Gardasil, talk to your health care professional to see if Gardasil 9 is right for you.

Can I get Gardasil 9 with other vaccines?

Gardasil 9 can be given at the same time as:

• Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine]
• Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

What are the possible side effects of Gardasil 9 Vaccine?

The most common side effects seen with Gardasil 9 are:

• pain, swelling, redness, itching, bruising, bleeding, and a lump where you got the shot
• headache
• fever
• nausea
• dizziness
• tiredness
• diarrhea
• abdominal pain
• sore throat

Studies show that there was more swelling where the shot was given when Gardasil 9 was given at the same time as Menactra and/or Adacel.

Tell the health care professional if you have any of these problems because these may be signs of an allergic reaction:

• difficulty breathing
• wheezing (bronchospasm)
• hives
• rash

Additional side effects that have been reported during general use for Gardasil 9 are shown below. Side effects reported during the general use of Gardasil are also shown below. Gardasil side effects are reported as they may be relevant to Gardasil 9 since the vaccines are similar in composition.

Gardasil 9:

• vomiting
• hives

Additionally, these side effects have been seen with the general use of Gardasil.

Gardasil:

• swollen glands (neck, armpit, or groin)
• joint pain
• unusual tiredness, weakness, or confusion
• chills
• generally feeling unwell
• leg pain
• shortness of breath
• chest pain
• aching muscles
• muscle weakness
• seizure
• bad stomach ache
• bleeding or bruising more easily than normal
• skin infection

You should contact your health care professional right away if you get any symptoms that bother you.

For a more complete list of side effects, ask the health care professional.

Call your health care professional for medical advice about side effects. You may also report any side effects to your doctor or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Gardasil 9 was not studied in women who knew they were pregnant. A pregnancy registry is available. You are encouraged to contact the registry as soon as you become aware of your pregnancy by calling 1-800-986-8999, or ask your health care professional to contact the registry for you.

General information about the safe and effective use of Gardasil 9 Vaccine

This document is a summary of information about Gardasil 9.
To learn more about Gardasil 9, please talk to the health care professional or visit www.GARDASIL9.com.

What are the ingredients in Gardasil 9 Vaccine?

Gardasil 9 contains:

• Proteins of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
• Amorphous aluminum hydroxyphosphate sulfate
• Yeast protein
• Sodium chloride
• L-histidine
• Polysorbate 80
• Sodium borate
• Water