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.

10 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). 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.