Your recommendation matters, so start off strong1,2?
“While you’re here, I strongly recommend vaccinating with GARDASIL 9 to help protect you against certain HPV-related cancers and diseases.“
Have your answers ready if your patients have questions
| QUESTION | ANSWER |
|---|---|
| What are the chances that I’ll get HPV? | HPV doesn’t discriminate by age or gender,³ and up to 80% of sexually active people will have been infected with HPV in their lifetime.⁴ For most people, HPV will clear on its own. But for those who don’t clear the virus, it can cause certain HPVrelated cancers and diseases. |
| What will GARDASIL 9 help protect me against? | GARDASIL 9 can help protect against certain HPV-related cervical, vulvar, and vaginal cancers in women, and anal cancers, and genital warts in men and women.³ |
| I thought I was too old for GARDASIL 9. Can I still get it? | GARDASIL 9 is indicated for active immunization of individuals from the age of 9 years. |
| I thought HPV vaccination only worked if you got it before being sexually active? | It may not be too late to help protect yourself against HPV. If you’re already infected with one type of the virus, GARDASIL 9 may still help protect against other types of HPV that you haven’t been exposed to.⁴ |
| Do I really need to get vaccinated? I’ve only ever slept with one person. | You can be at risk even if you only have one sexual partner, because they may have been infected by a previous partner and the virus has no symptoms. Vaccination with GARDASIL 9 may also help protect you if you change sexual partners one day.4 |
| I use condoms, isn’t that enough to protect me from HPV? | HPV is most commonly transmitted through sexual intercourse, but because it can also spread through other intimate skin and mucous membrane contact, condom use may not fully protect you against HPV infection. 3,4 |
| Is GARDASIL 9 safe? | GARDASIL 9 was studied in 15,776 males and females worldwide and was generally well tolerated. The most common side effects were pain, swelling, redness, itching, and bruising; and headache, fever, nausea, dizziness and tiredness. Fainting can happen after getting the vaccine. |
Parents may have specific questions about GARDASIL 9 and their child
| QUESTION | ANSWER |
|---|---|
| Isn’t my child too young for the HPV vaccine? | GARDASIL 9 can be given to children as young as 9 years, and can be given to your child at the same time as other routine vaccinations. |
| I have plenty of time before I need to worry about HPV. Can’t we wait until my child is older? | It may seem early, but the ideal time to vaccinate your child against certain HPV related cancers is before they are exposed to the virus.3 |
| I’m still not sure if GARDASIL 9 is right for my child at their age. | Vaccines are recommended to be given before your child is exposed to a disease. This gives the immune system enough time to develop protection.⁴ That’s why we give the HPV vaccine earlier rather than later, to help protect them long before they are ever exposed.⁴ Also, if your child gets the shot between the ages of 9 and 14 years, they will only need two doses rather than three. |
When it comes to deciding to vaccinate, you play an important role! 1,2
HELP PROTECT YOUR PATIENTS TODAY
HPV=human papillomavirus
References:
- Gilkey MB, Calo WA, Moss JL, Shah PD, Marciniak MW, Brewer NT. Provider communication and HPV vaccination: the impact of recommendation quality. Vaccine. 2016;34(9):1187-1192. doi:10.1016/j.vaccine.2016.01.023.
- Wheldon CW, Garg A, Galvin AM, Moore JD, Thomson EL. Decision support needs for shared clinical decision-making regarding HPV vaccination among adults 27-45 years of age. Patient Educ Couns. 2021. doi.org/10.1016/j.pec.2021.04.016i.
- World Health Organization (WHO). Human papillomavirus vaccines: WHO position paper. Wkly Epidemiol Rec. 2017;19(92):241-268.
- World Health Organization. Questions and answers about HPV vaccination. http://www.euro.who.int/data/assets/pdf_file/0009/356841/Q-andA_HPV_Parents_EN.pdf.Published December 2017. Accessed September 7, 2021.
GARDASIL 9 – SELECTED SAFETY INFORMATION
Based on:
Gardasil 9 HC 3852-II-040-PI eng EMA 052021(CARIBBEAN)
Therapeutic uses
Gardasil 9 is indicated for active immunization of individuals from the age of 9 years against the following HPV diseases:
• Premalignant lesions and cancers affecting the cervix, vulva, vagina, and anus caused by vaccine HPV types.
• Genital warts (Condyloma acuminata) caused by specific HPV types.
Dosage and administration
GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule: Individuals 9 to and including 14 years of age at time of first injection Gardasil 9 can be administered according to a 2-dose (0, 6 – 12 months) schedule. The second dose should be administered between 5 and 13 months after the first dose. If the second vaccine 2 dose is administered earlier than 5 months after the first dose, a third dose should always be administered. GARDASIL 9 can be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.
Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9
Contraindications
GARDASIL 9 is contraindicated in patients with hypersensitivity to either GARDASIL 9 or GARDASIL™ or any of the inactive ingredients in either vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9.
Warnings and precautions
As for any vaccine, vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. The vaccine has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical, vulvar, vaginal, and anal cancer, high-grade cervical, vulvar, vaginal, and anal dysplastic lesions, or genital warts. It is also not intended to prevent progression of other established HPV-related lesions. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after HPV vaccination. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9.
The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.
Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may have reduced antibody response to active immunization.
This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Use in special populations
Pregnancy should be avoided during the vaccination regimen for GARDASIL 9. Gardasil 9 can be used during breast-feeding. The safety and efficacy of GARDASIL 9 have not been evaluated in children younger than 9 years. The safety immunogenicity, and efficacy of GARDASIL 9 have not been fully evaluated in HIV-infected individuals.
Adverse reactions
The most common (>10%) vaccine-related adverse experiences were observed among recipients of GARDASIL 9 were temperature and injection-site pain, swelling, erythema, headache. And common (>1%) vaccine-related adverse experiences observed reported were pruritus, bruising, pyrexia, nausea, dizziness, pain in extremity, hematoma, and fatigue.
Post-marketing reports:
The following adverse experiences have been spontaneously reported during post-approval use of GARDASIL and may also be seen in post-marketing experience with GARDASIL9. Cellulitis, idiopathic thrombocytopenic purpura, lymphadenopathy, acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, syncope sometimes accompanied by tonic-clonic movements; nausea, vomiting; arthralgia, myalgia; asthenia, chills, fatigue, malaise; hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria. These experiences were reported voluntarily from a population of uncertain size. It is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Before administering GARDASIL®9, please read the complete Prescribing Information.