Gardasil 9 Dosage/Direction for Use

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.
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.
The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used.
Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
After thorough agitation, GARDASIL 9 is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Discard the product if particulates are present or if it appears discolored.
The prefilled syringe is for single use only and should not be used for more than one individual. Inject the entire contents of the syringe.
Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL: It is recommended that individuals who receive a first dose of GARDASIL 9 complete the vaccination course with GARDASIL 9.
Studies using a mixed regimen (interchangeability) of HPV vaccines were not performed for GARDASIL 9.
If the decision is made to administer GARDASIL 9 after receiving 3 doses of GARDASIL, there should be an interval of at least 12 months between completion of vaccination with GARDASIL and the start of vaccination with GARDASIL 9.