HIGHLIGHTS OF PRESCRIBING INFORMATION Each …

1 HIGHLIGHTS OF PRESCRIBING INFORMATION Each dose of gardasil 9 is These HIGHLIGHTS do not include all the INFORMATION needed to use Administer gardasil 9 as follows: ( ). gardasil 9 safely and effectively. See full PRESCRIBING INFORMATION for gardasil 9. Age Regimen Schedule gardasil 9 9 through 14 years 2-dose 0, 6 to 12 months*. (Human Papillomavirus 9-valent Vaccine, Recombinant). 3-dose 0, 2, 6 months Suspension for intramuscular injection Initial Approval: 2014 15 through 26 years 3-dose 0, 2, 6 months ----------------------------INDICATIONS AND USAGE ---------------------------- *If the second dose is administered earlier than 5 months after the first gardasil 9 is a vaccine indicated in girls and women 9 through 26 dose, administer a third dose at least 4 months after the second dose.

2 Years of age for the prevention of the following diseases: ( and ). Cervical, vulvar, vaginal, and anal cancer caused by Human --------------------- DOSAGE FORMS AND STRENGTHS --------------------- Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. ( ) suspension for injection as a single-dose vial and prefilled Genital warts (condyloma acuminata) caused by HPV types 6 and syringe. (3, 11). 11. ( ) -------------------------------CONTRAIND ICATIONS------------------------------- And the following precancerous or dysplastic lesions caused by HPV Hypersensitivity, including severe allergic reactions to yeast (a vaccine types 6, 11, 16, 18, 31, 33, 45, 52, and 58: component), or after a previous dose of gardasil 9 or gardasil .

3 Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical (4, 11). adenocarcinoma in situ (AIS). ( ). Cervical intraepithelial neoplasia (CIN) grade 1. ( ) ----------------------- WARNINGS AND PRECAUTIONS ----------------------- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. ( ) Because vaccinees may develop syncope, sometimes resulting in Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. ( ) falling with injury, observation for 15 minutes after administration is Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. ( ) recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following gardasil 9 is indicated in boys and men 9 through 26 years of age HPV vaccination.

4 When syncope is associated with tonic-clonic for the prevention of the following diseases: movements, the activity is usually transient and typically responds to Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. restoring cerebral perfusion by maintaining a supine or Trendelenburg ( ) position. ( ). Genital warts (condyloma acuminata) caused by HPV types 6 and ------------------------------ ADVERSE REACTIONS ------------------------------ 11. ( ) The most common ( 10%) local and systemic adverse reactions And the following precancerous or dysplastic lesions caused by HPV reported: types 6, 11, 16, 18, 31, 33, 45, 52, and 58: In girls and women 16 through 26 years of age: injection-site pain Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.

5 ( ) ( ), injection-site swelling ( ), injection-site erythema ( ) and headache ( ). ( ). Limitations of Use and Effectiveness: In girls 9 through 15 years of age: injection-site pain ( ), gardasil 9 does not eliminate the necessity for women to injection-site swelling ( ), injection-site erythema ( ) and continue to undergo recommended cervical cancer screening. headache ( ). ( ). ( , 17) In boys and men 16 through 26 years of age: injection-site pain Recipients of gardasil 9 should not discontinue anal cancer ( ), injection-site swelling ( ) and injection-site erythema screening if it has been recommended by a health care provider. ( ). ( ). ( , 17) In boys 9 through 15 years of age: injection-site pain ( ), gardasil 9 has not been demonstrated to provide protection injection-site swelling ( ), and injection-site erythema against disease from vaccine HPV types to which a person has ( ).

6 ( ). previously been exposed through sexual activity. ( ). gardasil 9 has not been demonstrated to protect against To report SUSPECTED ADVERSE REACTIONS, contact Merck diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- and 58. ( ) 888-4231 or VAERS at 1-800-822-7967 or gardasil 9 is not a treatment for external genital lesions; ----------------------- USE IN SPECIFIC POPULATIONS ----------------------- cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN. Pregnancy registry: available at 1-800-986-8999. ( ). ( ). Not all vulvar, vaginal, and anal cancers are caused by HPV, and Safety and effectiveness of gardasil 9 have not been established in gardasil 9 protects only against those vulvar, vaginal, and anal the following populations: cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58.

7 ( ) Children below the age of 9 years. ( ). gardasil 9 does not protect against genital diseases not caused Immunocompromised individuals. Response to gardasil 9 may by HPV. ( ) be diminished. ( ). Vaccination with gardasil 9 may not result in protection in all vaccine recipients. ( ) See 17 for PATIENT COUNSELING INFORMATION and Safety and effectiveness of gardasil 9 have not been assessed FDA-approved patient labeling. in individuals older than 26 years of age. ( ) Revised: 02/2018. ----------------------- DOSAGE AND ADMINISTRATION ----------------------- For intramuscular administration only. (2). FULL PRESCRIBING INFORMATION : CONTENTS* Administration of gardasil 9 in Individuals Who Have Been Previously Vaccinated with gardasil .

8 1 INDICATIONS AND USAGE 3 DOSAGE FORMS AND STRENGTHS. Girls and Women 4 CONTRAINDICATIONS. Boys and Men 5 WARNINGS AND PRECAUTIONS. Limitations of Use and Effectiveness Syncope 2 DOSAGE AND ADMINISTRATION Managing Allergic Reactions Dosage 6 ADVERSE REACTIONS. Method of Administration Clinical Trials Experience Post-Marketing Experience 7 DRUG INTERACTIONS Efficacy and Effectiveness Data for gardasil . Use with Systemic Immunosuppressive Medications Clinical Trials for gardasil 9. 8 USE IN SPECIFIC POPULATIONS Efficacy HPV Types 31, 33, 45, 52 and 58 in Girls and Pregnancy Women 16 through 26 Years of Age Lactation Immunogenicity of a 3-Dose Regimen Pediatric Use Immune Responses to gardasil 9 Using a 2-Dose Geriatric Use Regimen in Individuals 9 through 14 Years of Age Immunocompromised Individuals Studies with Menactra and Adacel 11 DESCRIPTION 15 REFERENCES.

9 12 CLINICAL PHARMACOLOGY 16 HOW SUPPLIED/STORAGE AND HANDLING. Mechanism of Action 17 PATIENT COUNSELING INFORMATION . 13 NONCLINICAL TOXICOLOGY. Carcinogenesis, Mutagenesis, Impairment of Fertility *Sections or subsections omitted from the full PRESCRIBING INFORMATION 14 CLINICAL STUDIES are not listed. FULL PRESCRIBING INFORMATION . 1 INDICATIONS AND USAGE. Girls and Women . gardasil 9 is a vaccine indicated in 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 acuminata) caused by HPV types 6 and 11. And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).

10 Cervical intraepithelial neoplasia (CIN) grade 1. Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Boys and Men gardasil 9 is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases: Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Genital warts (condyloma acuminata) caused by HPV types 6 and 11. And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Limitations of Use and Effectiveness The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.