Drug Database: Human Papillomavirus 9-Valent Vaccine, Recombinant

What is Gardasil 9?What is Gardasil 9?

What is Gardasil 9?

Gardasil 9 is a vaccine approved by the U.S. Food and Drug Administration (FDA) for use in people 9 through 45 years of age to protect against the following diseases caused by certain types of human papillomavirus (HPV):

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

HPV infection is a risk factor for the development of the diseases listed above. HPV infection can be an opportunistic infection (OI) of HIV. An OI is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as people with HIV—than in people with healthy immune systems. To learn more about OIs, read the HIVinfo What is an Opportunistic Infection? fact sheet. To learn how HIV and HPV are connected, read the HIVinfo HIV and Human Papillomavirus fact sheet.

The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV include recommendations on the use of Gardasil 9 in people with HIV. Additionally, the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children With and Exposed to HIV include information on immunizations for preventable diseases, such as HPV vaccination, in children and adolescents with HIV.

What should I tell my health care provider before receiving Gardasil 9?What should I tell my health care provider before receiving Gardasil 9?

What should I tell my health care provider before receiving Gardasil 9?

Before receiving Gardasil 9, tell your health care provider:

• If you or your child is allergic to any ingredients in Gardasil 9 (including yeast, amorphous aluminum hydroxyphosphate sulfate, or polysorbate 80) or any medicines.
• If you or your child has ever had any reactions to a previous dose of Gardasil 9 or any other HPV vaccine.
• About any medical conditions you or your child has or has had, including:
  • Fever over 100°F (37.8°C).
  • History of fainting while receiving a vaccination
  • Immune problems, such has HIV or cancer
• If you or your child takes medicines that might affect the immune system.
• About any health condition that may prevent you or your child from receiving medicine by injection.
• If you are pregnant, or plan to become pregnant. Talk to your health care provider about the risks and benefits of receiving Gardasil 9 during pregnancy. The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV may include other recommendations on the use of Gardasil 9 during pregnancy. Please refer to these guidelines for additional information.
• If you are breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you or your child is taking or plans to take. Gardasil 9 may affect the way other medicines or products work, and other medicines or products may affect how Gardasil 9 works. Ask your health care provider if there are interactions between Gardasil 9 and the medicines you or your child takes.

How is Gardasil 9 given?How is Gardasil 9 given?

How is Gardasil 9 given?

A health care provider gives the Gardasil 9 vaccine. The vaccine is usually given in the upper-arm or thigh muscle. In people with HIV, vaccination with Gardasil 9 is usually given as a series of three vaccine shots over a 6-month period. Your health care provider will decide how many shots you or your child will need and when to get them. Read any printed information that your health care provider gives you about HPV vaccines.

What side effects can Gardasil 9 cause?What side effects can Gardasil 9 cause?

What side effects can Gardasil 9 cause?

Gardasil 9 may cause side effects that can be mild or serious. To learn about possible side effects, see the FDA drug label or talk to your health care provider or pharmacist. Tell your health care professional if you have any side effect that bothers you or that does not go away. Your health care professional may be able to tell you about ways to prevent or reduce some side effects.

You may report vaccine side effects using the Vaccine Adverse Event Reporting System online.

Where can I find more information about Gardasil 9?Where can I find more information about Gardasil 9?

Where can I find more information about Gardasil 9?

• Recommendations on the use of Gardasil 9 in people with HIV, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children With and Exposed to HIV.
• This Patient Version drug summary is based on the following FDA label(s): Injection (suspension). The Patient Information section includes information for people receiving Gardasil 9.
• Vaccine Information Statement (VIS) for HPV (Human Papillomavirus) Vaccine available from the Centers for Disease Control and Prevention (CDC).
• The American Hospital Formulary Service (AHFS) Patient Medication Information for human papillomavirus (HPV) vaccine available from MedlinePlus.
• Gardasil 9-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)