* '''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.
[[File:Gardasil_vaccine_and_box_new.jpg|thumb|right|Gardasil vaccine and packaging]]
'''Gardasil''' is a [[vaccine]] designed to prevent certain strains of the [[human papillomavirus]] (HPV), which are associated with the development of [[cervical cancer]], [[genital warts]], and other HPV-related conditions. It is a recombinant vaccine that targets four major types of HPV: 6, 11, 16, and 18.
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==Development and Approval==
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Gardasil was developed by the pharmaceutical company [[Merck & Co.]] and was first approved by the [[United States Food and Drug Administration]] (FDA) in 2006. The vaccine was a significant advancement in the prevention of HPV-related diseases, particularly cervical cancer, which is one of the most common cancers affecting women worldwide.
Gardasil works by stimulating the body's [[immune system]] to produce antibodies against the HPV types included in the vaccine. These antibodies help prevent infection by neutralizing the virus before it can infect cells. The vaccine is administered as an [[intramuscular injection]], typically in a series of three doses over six months.
== '''What are the uses of this medicine?''' ==
==Indications==
Gardasil is recommended for use in both [[females]] and [[males]] to prevent HPV-related diseases. It is most effective when administered before the onset of [[sexual activity]], as it does not treat existing HPV infections. The vaccine is typically recommended for preteens and young adults, but it can be given to individuals up to 45 years of age.
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|Human Papilloma virus]] (HPV):
==Efficacy==
* [[Cervical cancer]]
Clinical trials have demonstrated that Gardasil is highly effective in preventing infections with HPV types 6, 11, 16, and 18. These types are responsible for the majority of cervical cancer cases and genital warts. The vaccine has also shown efficacy in preventing other HPV-related cancers, such as [[anal cancer]] and [[oropharyngeal cancer]].
* [[Vulvar]] and [[Vaginal cancer|vaginal cancers]]
* [[Anal cancer]]
* [[Genital warts]]
* Precancerous cervical, vaginal, vulvar, and anal [[lesions]]
GARDASIL is used for b'''oys and men 9 through 26 years of age''' to help protect against the following diseases caused by HPV:
==Safety and Side Effects==
* [[Anal cancer]]
Gardasil has been extensively studied for safety and is generally well-tolerated. Common side effects include [[pain]] at the injection site, [[fever]], [[headache]], and [[nausea]]. Serious side effects are rare, and the benefits of vaccination in preventing HPV-related diseases outweigh the risks.
* [[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.
==Public Health Impact==
The introduction of Gardasil has had a significant impact on public health by reducing the incidence of HPV-related diseases. Vaccination programs have led to a decrease in the prevalence of HPV infections and a reduction in the rates of cervical cancer and genital warts in vaccinated populations.
'''Limitations of use:'''
==Related pages==
* GARDASIL cannot protect you from a disease that is caused by other types of [[HPV]], other viruses, or [[bacteria]].
* [[Human papillomavirus]]
* GARDASIL does not treat HPV infection.
* [[Cervical cancer]]
* You cannot get HPV or any of the above diseases from GARDASIL.
* 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, [[Polysorbates|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|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.
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Latest revision as of 11:34, 15 February 2025
Gardasil vaccine and packaging
Gardasil is a vaccine designed to prevent certain strains of the human papillomavirus (HPV), which are associated with the development of cervical cancer, genital warts, and other HPV-related conditions. It is a recombinant vaccine that targets four major types of HPV: 6, 11, 16, and 18.
Gardasil was developed by the pharmaceutical company Merck & Co. and was first approved by the United States Food and Drug Administration (FDA) in 2006. The vaccine was a significant advancement in the prevention of HPV-related diseases, particularly cervical cancer, which is one of the most common cancers affecting women worldwide.
Gardasil works by stimulating the body's immune system to produce antibodies against the HPV types included in the vaccine. These antibodies help prevent infection by neutralizing the virus before it can infect cells. The vaccine is administered as an intramuscular injection, typically in a series of three doses over six months.
Gardasil is recommended for use in both females and males to prevent HPV-related diseases. It is most effective when administered before the onset of sexual activity, as it does not treat existing HPV infections. The vaccine is typically recommended for preteens and young adults, but it can be given to individuals up to 45 years of age.
Clinical trials have demonstrated that Gardasil is highly effective in preventing infections with HPV types 6, 11, 16, and 18. These types are responsible for the majority of cervical cancer cases and genital warts. The vaccine has also shown efficacy in preventing other HPV-related cancers, such as anal cancer and oropharyngeal cancer.
Gardasil has been extensively studied for safety and is generally well-tolerated. Common side effects include pain at the injection site, fever, headache, and nausea. Serious side effects are rare, and the benefits of vaccination in preventing HPV-related diseases outweigh the risks.
The introduction of Gardasil has had a significant impact on public health by reducing the incidence of HPV-related diseases. Vaccination programs have led to a decrease in the prevalence of HPV infections and a reduction in the rates of cervical cancer and genital warts in vaccinated populations.
