JUST THE FACTS
HPV (HUMAN PAPILLOMAVIRUS)
HPV (HUMAN PAPILLOMAVIRUS)
Human Papillomavirus (HPV) "GARDASIL 9" is made by vaccine manufacturer Merck. 3- doses of GARDASIL 9 vaccine are recommended for girls and women 9 through 26 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Genital warts (condyloma acuminate) caused by HPV types 6 and 11. Initial U.S Approval: 2014
SYMPTOMS of HPV:
Painless warts, Genital or anal discharge, bleeding, itching, or pain, Pain when you urinate
HPV occurs from sexual contact. About 50 percent of sexually active men and women acquire genital HPV infection at some point in their lives. Most people never know they have HPV and over 95% of cases heal themselves.
Amino Acids - (CARBON, HYDROGEN, OXYGEN, NITROGEN)
Amorphous Aluminum - (ALUMINUM)
Hydroxyphosphate Sulfate - (ALUMINUM PHOSPHATE)
Sodium Chloride - (SALT)
L-Histidine - (AMINO ACID)
Polysorbate 80 - (SURFACTANT and EMULSIFIER)
Sodium Borate - (BORAX)
Yeast Protein - (FUNGUS)
YOU SHOULD NOT GET THIS VACCINATION IF:
1. Anyone who has had a severe (life-threatening) allergic reaction to a dose of HPV vaccine should not get another dose.
2. Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine.
3. Severe allergies that you know of, including a severe allergy to yeast.
4. HPV vaccine is not recommended for pregnant women. Any woman who learns she was pregnant when she got HPV vaccine is encouraged to contact the manufacturer’s registry for HPV vaccination during pregnancy at 1-800-986-8999.
5. Women who are breastfeeding may be vaccinated.
6. If you have a mild illness, such as a cold, you can probably get the vaccine today.
7. If you are moderately or severely ill, you should probably wait until you recover.
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL
1. Syncope (Fainting) is sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination.
2. Medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL 9.
3. There are NO adequate and well-controlled studies of GARDASIL 9 in pregnant women
4. Available data are NOT sufficient to assess the effects of GARDASIL 9 on the breastfed infant or on milk production/excretion
5. Safety and Effectiveness have NOT been established in pediatric patients below 9 years of age.
6. The safety and effectiveness of GARDASIL 9 have NOT been evaluated in a geriatric population, defined as individuals aged 65 years and over.
7. GARDASIL 9 has NOT been evaluated for Carcinogenicity (CANCER), Genotoxicity (DNA MUTATION) or Impairment of male fertility (INFERTILITY)
8. Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform the patient, parent, or guardian:
Vaccination does NOT eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL 9 should continue to undergo cervical cancer screening per standard of care. Recipients of GARDASIL 9 should NOT discontinue anal cancer screening if it has been recommended by a health care provider. GARDASIL 9 has NOT been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. Vaccine information is required to be given with each vaccination to the patient, parent, or guardian. Provide information regarding benefits and RISKS associated with vaccination.
9. Safety and effectiveness of GARDASIL 9 have NOT been established in pregnant women