GARDASIL 9 SUSPENSION FOR INJECTION
1. INDICATIONS AND USAGE
GARDASIL 9 is a vaccine indicated in girls and women from 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, and anal cancer; premalignant genital lesions (cervical, vulvar and vaginal); premalignant anal lesions; HPV infections; cervical adenocarcinoma in situ (AIS); and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
GARDASIL 9 is indicated in boys and men from 9 through 45 years of age for the prevention of premalignant lesions and HPV infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58 and genital warts (condyloma acuminata) caused by HPV types 6 and 11.
4. 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.
2. DOSAGE AND ADMINISTRATION
2.1 General
Dosage
GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule:
First dose: at elected date
Second dose: 2 months after the first dose
Third dose: 6 months after the first dose
Individuals are encouraged to adhere to the 0, 2, and 6 months vaccination schedule. However, in clinical studies, efficacy has been demonstrated in individuals who have received all 3 doses within a 1-year period. The second dose should be administered at least 1 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.
Alternatively, in individuals 9 through 14 years of age, GARDASIL 9 can be administered according to a 2-dose schedule; the second dose should be administered between 5 and 13 months after the first dose. If the second vaccine dose is administered earlier than 5 months after the first dose, a third dose should always be administered.
The use of GARDASIL 9 should be in accordance with official recommendations.
It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9.
The need for a booster dose has not been established. The duration of protection is currently unknown.
Method of Administration
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.
GARDASIL 9 must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.
2.2 Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL.
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for GARDASIL 9.
Safety and immunogenicity of GARDASIL 9 were assessed in individuals who previously completed a three-dose vaccination series with GARDASIL [See 8 ADVERSE REACTIONS and 10 CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information ].
