GARDASIL 9 SUSPENSION FOR INJECTION

INJECTION, SUSPENSION

**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 _\[See 8 ADVERSE REACTIONS and 10 CLINICAL STUDIES_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.