Gardasil 9

What is Gardasil 9?

• Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a vaccine used to prevent anal, cervical, vaginal, and vulvar cancer caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58 and genital warts caused by HPV types 6 and 11. It is also used to prevent lesions that may lead to anal, cervical, vaginal, or vulvar cancer.

What are the uses of this medicine?

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).

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.

Limitations of use: 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.

How does this medicine work?

• Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses.
• Efficacy of GARDASIL 9 against anogenital diseases related to the vaccine HPV types in human beings is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients 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 drug interactions can this medicine cause?

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to 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)]

Is this medicine FDA approved?

• In 2014, the U.S. Food and Drug Administration (FDA) approved a nine-valent version, Gardasil 9, to protect against infection with the strains covered by the first generation of Gardasil as well as five other HPV strains responsible for 20% of cervical cancers (types 31, 33, 45, 52, and 58).
• In 2018, the FDA approved expanded use of Gardasil 9 for individuals aged 27 through 45 years old.

How should this medicine be used?

Recommended dosage:

• Each dose of GARDASIL 9 is 0.5-mL.

Administer GARDASIL 9 as follows:

9 through 14 years old:

• you will need 2-shots given as
• Dose 1: first shot
• Dose 2: second shot given between 6 and 12 months after the first shot

or

• 3-shots† given as
• Dose 1: first shot
• Dose 2: second shot given 2 months after the first shot
• Dose 3: third shot given 6 months after the first shot

15 through 45 years old: you will need 3-shots given as

• Dose 1: first shot
• Dose 2: second shot given 2 months after the first shot
• Dose 3: third shot given 6 months after the first shot

Administration:

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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.5-mL suspension for injection as a single-dose vial and prefilled syringe.

This medicine is available in fallowing brand namesː

• GARDASIL 9

What side effects can this medication cause?

The most common side effects of this medicine include:

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

What special precautions should I follow?

• Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
• Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL 9.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of GARDASIL 9 in pregnant women.
• Available human data do not demonstrate vaccine-associated increase in risk of major birth defects and miscarriages when GARDASIL 9 is administered during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients below 9 years of age.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

Manuf. and Dist. by:

• Merck Sharp & Dohme Corp., a subsidiary of
• MERCK & CO., INC., Whitehouse Station, NJ , USA

What should I know about storage and disposal of this medication?

• Store refrigerated at 2 to 8°C (36 to 46°F).
• Do not freeze.
• Protect from light.
• GARDASIL 9 should be administered as soon as possible after being removed from refrigeration.
• GARDASIL 9 can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours.
• Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours.
• These are not, however, recommendations for storage.

• Dailymed label info on Gardasil 9
• FDA Gardasil 9

Gardasil 9 Resources
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