Gardasil

What is Gardasil?

• Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) is a vaccine used to prevent anal, cervical, vaginal, and vulvar cancer caused by human papilloma virus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11.

What are the uses of this medicine?

GARDASIL is a vaccine (injection/shot) that is used for girls and women 9 through 26 years of age to help protect against the following diseases caused by Human Papilloma virus (HPV):

• Cervical cancer
• Vulvar and vaginal cancers
• Anal cancer
• Genital warts
• Precancerous cervical, vaginal, vulvar, and anal lesions

GARDASIL is used for boys and men 9 through 26 years of age to help protect against the following diseases caused by HPV:

• Anal cancer
• Genital warts
• Precancerous anal lesions

• The diseases listed above have many causes, and GARDASIL only protects against diseases caused by certain kinds of HPV (called Type 6, Type 11, Type 16, and Type 18). Most of the time, these 4 types of HPV are responsible for the diseases listed above.

Limitations of use:

• GARDASIL cannot protect you from a disease that is caused by other types of HPV, other viruses, or bacteria.
• GARDASIL does not treat HPV infection.
• You cannot get HPV or any of the above diseases from GARDASIL.

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.
• Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• an allergic reaction after getting a dose of GARDASIL.
• a severe allergic reaction to yeast, 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 can be given at the same time as RECOMBIVAX HB®1 [hepatitis B vaccine (recombinant)] or Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)].

Is this medicine FDA approved?

• The vaccine was approved for medical use in the United States in 2006, initially for use in females aged 9–26.
• In 2007, the Advisory Committee on Immunization Practices (ACIP) recommended gardasil for routine vaccination of girls aged 11 and 12 years.
• As of August 2009, vaccination was recommended for both males and females before adolescence and the beginning of potential sexual activity.

How should this medicine be used?

Recommended dosage:

• GARDASIL should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months.

Administration: GARDASIL is a shot that is usually given in the arm muscle. You will need 3 shots given on the following schedule:

• Dose 1: at a date you and your health care provider choose.
• Dose 2: 2 months after Dose 1.
• Dose 3: 6 months after Dose 1.

• Fainting can happen after getting GARDASIL.
• Sometimes people who faint can fall and hurt themselves.
• For this reason, your health care provider may ask you to sit or lie down for 15 minutes after you get GARDASIL.
• Some people who faint might shake or become stiff.
• This may require evaluation or treatment by your health care provider.
• Make sure that you get all 3 doses on time so that you get the best protection.
• If you miss a dose, talk to your health care provider.

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

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain, swelling, itching, bruising, and redness at the injection site
• headache
• fever
• nausea
• dizziness
• vomiting
• fainting

What special precautions should I follow?

• Because vaccinees 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 vaccination with GARDASIL. 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• In general, the adverse event profile reported with overdose was comparable to recommended single doses of GARDASIL.

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human responses, GARDASIL should be used during pregnancy only if clearly needed.

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?

• The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.

Who manufactures and distributes this medicine?

Manufactured and Distributed 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 should be administered as soon as possible after being removed from refrigeration.
• GARDASIL can be out of refrigeration (at temperatures at or below 25°C/77°F), for a total time of not more than 72 hours.

• Dailymed label info on Gardasil
• FDA Gardasil