Gardasil (HPV Vaccine)
Omudhome Ogbru, PharmD
Omudhome Ogbru, PharmD
Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.
Medical and Pharmacy Editor:
GENERIC NAME: Recombinant Human Papillomavirus Quadrivalent Vaccine
BRAND NAME: Gardasil
DRUG CLASS AND MECHANISM: 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.
GENERIC AVAILABLE: No
PREPARATIONS: Injection: 0.5 ml single-dose vial and pre-filled syringe
STORAGE: Gardasil should be stored refrigerated at 2 to 8 C (36 to 46 F) and should be protected from light and not frozen.
PRESCRIBED FOR: Gardasil is used for the prevention of infection with HPV types 6, 11, 16, and 18 in girls and women 9 to 26 years of age.
It also is approved for preventing genital warts caused by HPV types 6 and 11 and anal cancer caused by HPV types 16 and 18 in males 9 to 26 years old.
Gardasil protects against cervical cancer (cancer of the lower end of the uterus or womb); abnormal and precancerous cervical lesions; abnormal and precancerous vaginal lesions; abnormal and precancerous vulvar lesions; precancerous anal lesions and genital warts.
Gardasil does not treat active cervical cancer, active genital warts, or other active genital lesions caused by HPV.
Individuals with a compromised immune system will not respond as well to Gardasil as individuals with a normal immune system.
Women should continue cervical cancer screening even after receiving vaccination with Gardasil.
DOSING: 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.
DRUG INTERACTIONS: 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.
PREGNANCY: Gardasil has not been adequately evaluated in pregnant women. It should only be used in pregnant women if it is clearly needed.
NURSING MOTHERS: It is not known whether Gardasil or the antibodies induced by Gardasil are excreted in breast milk.
SIDE EFFECTS: The most common side effects of Gardasil are fever, nausea, vomiting, fainting, dizziness, and 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.
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