Gardasil (HPV Vaccine): Drug Facts, Side Effects and Dosing

What is Gardasil Vaccine (HPV), and how does it work (mechanism of action)?

Gardasil is a human papillomavirus (HPV) vaccine. Gardasil is a sterile preparation for intramuscular injection and contains purified inactive proteins from HPV types 6, 11, 16, and 18. The proteins in Gardasil are structural, virus-like proteins (VLP) that resemble the HPV virus. The proteins can activate the immune system but cannot give rise to replicating virus. Viral proteins used in Gardasil are manufactured in yeast cells (S. cerevisiae) using recombinant technology. Once released from yeast cells, the VLPs are purified, combined with a catalyst (amorphous aluminum hydroxyphosphate sulfate) and a purification buffer. Human papillomavirus causes cervical cancer, cervical adenocarcinoma, vaginal cancer, genital warts, and anal cancer. Gardasil works by stimulating the immune system to attack HPV types 6, 11, 16, and 18. Once Gardasil is administered, the body's immune system recognizes the viral proteins in Gardasil as foreign, and develops antibodies against them, thus providing immunity from future infections. In the event of HPV exposure following vaccination, the body will already be primed to fight the infection. HPV types 6, 11, 16, and 18 are commonly associated with HPV infections. HPV 16 and 18 cause 70% of cervical cancer and HPV 6, 11, 16 and 18 cause approximately 90% of genital warts. The FDA approved Gardasil in June 2007.

What brand names are available for Gardasil Vaccine (HPV)?

Gardasil

Is Gardasil Vaccine (HPV) available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for Gardasil Vaccine (HPV)?

Yes

What are the uses for Gardasil Vaccine (HPV)?

In girls and women

Gardasil is a vaccine used in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV):

Cervical, vulvar, vaginal, and anal cancer
Genital warts (condyloma acuminata)

And the following precancerous or dysplastic lesions:

Cervical intraepithelial neoplasia (CIN)
Cervical adenocarcinoma in situ (AIS)
Vulvar intraepithelial neoplasia (VIN)
Vaginal intraepithelial neoplasia (VaIN)
Anal intraepithelial neoplasia (AIN)

In boys and men

Gardasil is used in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV:

Anal cancer
Genital warts (condyloma acuminata)

And the following precancerous or dysplastic lesions:

Anal intraepithelial neoplasia (AIN)

What are the side effects of Gardasil Vaccine (HPV)?

The most common side effects of Gardasil are:

fever,
nausea,
vomiting,
fainting,
dizziness,
mild or moderate pain,
swelling,
itching, and
redness at the injection site.

Patients should be observed for 15 minutes after injection because of the possibility of fainting. Allergic reactions, which may be severe, also occur.

Other important side effects include:

swollen glands,
Guillain-Barre syndrome,
headache,
joint pain,
aching muscles,
tiredness,
weakness.

People allergic to any component in Gardasil should not use Gardasil.

What is the dosage for Gardasil Vaccine (HPV)?

Gardasil 0.5 ml is injected intramuscularly as three separate doses. The first dose is administered at the patient's convenience, the second dose two months after the first dose, and the third dose six months after the first dose.

QUESTION

Condoms are the best protection from sexually transmitted diseases (STDs).
See Answer

Which drugs or supplements interact with Gardasil Vaccine (HPV)?

Gardasil may be administered concomitantly (at different sites) with hepatitis B vaccine, Menactra (Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine), and Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed). The use of immunosuppressive drugs reduces the efficacy of Gardasil. Hormonal contraceptives do not interact with Gardasil.

Is Gardasil Vaccine (HPV) safe to take if I’m pregnant or breastfeeding?

Gardasil has not been adequately evaluated in pregnant women. It should only be used in pregnant women if it is clearly needed.

It is not known whether Gardasil or the antibodies induced by Gardasil are excreted in breast milk.

What else should I know about Gardasil Vaccine (HPV)?

What preparations of Gardasil Vaccine (HPV) are available?

Injection: 0.5 ml single-dose vial and pre-filled syringe

How should I keep Gardasil Vaccine (HPV) stored?

Gardasil should be stored refrigerated at 2 C to 8 C (36 F to 46 F) and should be protected from light and not frozen.