Indications & Uses
Human Papillomavirus Quadrivalent (Gardasil) is a vaccine for girls and women 9 through 26 years of age. It prevents diseases caused by the Human Papillomavirus (HPV) types the vaccine covers. These are cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18, and genital warts (condyloma acuminata) caused by HPV types 6 and 11. It also prevents these precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18: cervical intraepithelial neoplasia (CIN) grade 2/3, cervical adenocarcinoma in situ (AIS), and cervical intraepithelial neoplasia (CIN) grade 1. The list continues with vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, and anal intraepithelial neoplasia (AIN) grades 1, 2 and 3. For boys and men 9 through 45 years of age, Human Papillomavirus Quadrivalent is used to prevent anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58. It also prevents genital warts (condyloma acuminata) caused by HPV types 6 and 11. The precancerous or dysplastic lesions it prevents in this group are anal intraepithelial neoplasia (AIN) grades 1, 2 and 3, caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.
Pharmacology
HPV infects only human beings. Studies in animals with similar animal papillomaviruses suggest that L1 VLP vaccines may work by building up humoral immune responses. In people, Human Papillomavirus Quadrivalent is thought to protect against anogenital diseases linked to the vaccine HPV types through the humoral immune responses the vaccine produces. The exact way it protects is still not known.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For ages 9 through 14 years, the 2-dose schedule is 0 and 6 to 12 months. If the second dose is given earlier than 5 months after the first, give a third dose at least 4 months after the second. The 3-dose schedule is 0, 2 and 6 months. For ages 15 through 45 years, the schedule is 3 doses at 0, 2 and 6 months.
Side Effects
In trials of Human Papillomavirus Quadrivalent vaccine, the most common local and systemic reactions (those seen in 10% or more of people) were as follows. In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0%) and headache (14.6%). In girls 9 through 15 years of age: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%) and headache (11.4%). In women 27 through 45 years of age: injection-site pain (82.8%), injection-site swelling (23.3%), injection-site erythema (16.9%) and headache (13.6%). In boys and men 16 through 26 years of age: injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%). In boys 9 through 15 years of age: injection-site pain (71.5%), injection-site swelling (26.9%) and injection-site erythema (24.9%).
Cautions & Contraindications
Warnings & Precautions
People who receive Human Papillomavirus Quadrivalent vaccine can faint, and sometimes they fall and get hurt. So it's recommended that they are observed for 15 minutes after the vaccine is given. Fainting after vaccination with Human Papillomavirus Quadrivalent has been reported, and in some cases it came with tonic-clonic movements and other seizure-like activity. When fainting does come with tonic-clonic movements, the activity is usually brief. It typically settles once blood flow to the brain is restored, which is done by keeping the person lying flat on their back (supine) or in the Trendelenburg position.
Contraindications
Don't give Human Papillomavirus Quadrivalent vaccine to anyone with hypersensitivity, including severe allergic reactions, to yeast (a vaccine component) or after a previous dose of the vaccine.
Pregnancy & Breastfeeding
Human Papillomavirus Quadrivalent is Pregnancy Category B. Studies in female rats, at doses equal to the recommended human dose, showed no sign that the vaccine impaired female fertility or harmed the fetus. But there are no adequate and well-controlled studies in pregnant women, and animal studies don't always predict how humans will respond. So Human Papillomavirus Quadrivalent should be used during pregnancy only if clearly needed.
It is not known whether the vaccine passes into human milk. Many drugs do pass into human milk, so caution should be taken when Human Papillomavirus Quadrivalent is given to a nursing woman.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Safety and effectiveness haven't been established in pediatric patients below 9 years of age.
Geriatric Use: Human Papillomavirus Quadrivalent hasn't been evaluated for safety and effectiveness in a geriatric population, which means people aged 65 years and over.
Overdose
Some people have been given higher doses of Human Papillomavirus Quadrivalent than the recommended amount. In general, the side effects reported after these higher doses were similar to those seen with the recommended single doses of Human Papillomavirus Quadrivalent.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Human Papillomavirus Quadrivalent in the refrigerator at 2 to 8°C. Don't let it freeze, and keep it away from light. Once it's taken out of the refrigerator, it should be given as soon as possible.
Common questions about Gardasil 0.5 ml
What is Gardasil 0.5 ml IM Injection?
Gardasil 0.5 ml IM Injection is a medicine that contains Human Papillomavirus Quadrivalent. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Vaccines group of medicines.
What is Gardasil used for?
Human Papillomavirus Quadrivalent (Gardasil) is a vaccine for girls and women 9 through 26 years of age. It prevents diseases caused by the Human Papillomavirus (HPV) types the vaccine covers.
What are the side effects of Gardasil?
In trials of Human Papillomavirus Quadrivalent vaccine, the most common local and systemic reactions (those seen in 10% or more of people) were as follows. In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0%) and headache (14.6%).
Can I take Gardasil during pregnancy or while breastfeeding?
Human Papillomavirus Quadrivalent is Pregnancy Category B. Studies in female rats, at doses equal to the recommended human dose, showed no sign that the vaccine impaired female fertility or harmed the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Gardasil?
Some people have been given higher doses of Human Papillomavirus Quadrivalent than the recommended amount. In general, the side effects reported after these higher doses were similar to those seen with the recommended single doses of Human Papillomavirus Quadrivalent. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Gardasil?
Keep Human Papillomavirus Quadrivalent in the refrigerator at 2 to 8°C. Don't let it freeze, and keep it away from light.
Do I need a prescription for Gardasil?
Gardasil is a prescription (Rx) medicine. Take it as your doctor advises.