gardasil 9 pi - Merck & Co.

1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese highlights do not include all the information needed to use gardasil 9 safely and effectively. See full prescribing information for gardasil 9(Human Papillomavirus 9-valentVaccine, Recombinant)Suspension for intramuscular injection Initial Approval: 2014----------------------------INDICATI ONS AND USAGE----------------------------GARDASI L9 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 analcancer 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). ( ) Cervical intraepithelial neoplasia (CIN) grade 1. ( ) Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.

2 ( ) Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. ( ) Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. ( )GARDASIL9 is indicated in boys and men 9 through 26years of age for the prevention ofthe 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: GARDASIL9does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. ( , 17) Recipients of GARDASIL9 should not discontinue anal cancer screening if it has been recommended by a health care provider. ( , 17) GARDASIL9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

3 ( ) GARDASIL9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58. ( ) GARDASIL9is not atreatment forexternal genital lesions; cervical, vulvar, vaginal, and analcancers; CIN; VIN; VaIN; or AIN. ( ) Not all vulvar, vaginal, and analcancers are caused by HPV, and GARDASIL9 protects only against those vulvar, vaginal, and analcancers caused by HPV 16, 18, 31, 33, 45, 52, and 58. ( ) GARDASIL9 does not protect against genital diseases not caused by HPV. ( ) Vaccination with GARDASIL9 may not result in protection in all vaccine recipients. ( ) Safety and effectivenessof GARDASIL9 have not been assessed in individuals older than 26 years of age.( )-----------------------DOSAGE AND ADMINISTRATION-----------------------For intramuscular administration only. (2)Each dose of GARDASIL9 is GARDASIL9 as follows:( )AgeRegimenSchedule9 through 14 years2-dose0, 6 to 12 months*3-dose0, 2, 6 months15 through 26 years3-dose0, 2, 6 months*If the second dose is administered earlier than 5 months after the first dose,administer a third dose at least 4 months after the second dose.

4 ( and )---------------------DOSAGE FORMS AND suspension for injection as a single-dose vial and prefilled syringe. (3, 11)-------------------------------CONTRA INDICATIONS----------------------------- --Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL9 or gardasil . (4, 11)-----------------------WARNINGS AND PRECAUTIONS-----------------------Becaus e vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. ( )------------------------------ADVERSE REACTIONS------------------------------T he most common ( 10%) local and systemic adverse reactions reported: In girls and women16 through 26 years of age: injection-site pain ( ), injection-site swelling ( ), injection-site erythema ( ) and headache ( ).

5 ( ) In girls 9 through 15 years of age: injection-site pain ( ), injection-site swelling ( ), injection-site erythema ( ) and headache ( ). ( ) In boys and men 16 through 26 years of age: injection-site pain ( ), injection-site swelling ( ) and injection-site erythema ( ). ( ) In boys 9 through 15 years of age: injection-site pain ( ), injection-site swelling ( ),and injection-site erythema ( ). ( )To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or IN SPECIFIC POPULATIONS-----------------------Pregna ncy registry: available at 1-800-986-8999. ( )Safety and effectiveness of GARDASIL9 have not been established in the following populations: Children below the age of 9 years. ( ) Immunocompromised individuals. Response to GARDASIL9 may be diminished. ( )See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient : 02/2018 FULL PRESCRIBING INFORMATION.

6 CONTENTS*1 INDICATIONS AND and of Use and Effectiveness2 DOSAGE AND of of GARDASIL9 in Individuals Who Have Been Previously Vaccinated with gardasil 3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND Allergic Reactions6 ADVERSE Trials Experience27 DRUG with Systemic Immunosuppressive Medications8 USE IN SPECIFIC Individuals11 DESCRIPTION12 CLINICAL of Action13 NONCLINICAL , Mutagenesis, Impairment of Fertility14 CLINICAL and Effectiveness Data for Trials for HPV Types 31, 33, 45, 52 and 58 in Girls and Women 16 through 26 Years of a 3-Dose Responses to GARDASIL9 Using a 2-Dose Regimen in Individuals 9 through 14 Years of with Menactra and Adacel15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not PRESCRIBING INFORMATION1 INDICATIONS AND and WomenGARDASIL 9 is a vaccine indicated in girls and women 9 through26years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and analcancer 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.

7 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 and MenGARDASIL9 is indicated in boys and men 9 through 26years 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 of Use and EffectivenessThe 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. Women who receive GARDASIL9 should continue to undergo cervical cancer screening per standard of care.

8 [See Patient Counseling Information (17).]Recipients of GARDASIL9 should not discontinue anal cancer screening if it has been recommended by a health care provider [see Patient Counseling Information (17)].GARDASIL9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and is not a treatment for external genital lesions; cervical, vulvar, vaginal, and analcancers; CIN; VIN; VaIN; or all vulvar, vaginal, and analcancers are caused by HPV, and GARDASIL9 protects only against those vulvar, vaginal, and analcancers caused by HPV 16, 18, 31, 33, 45, 52, and does not protect against genital diseases not caused by with GARDASIL9 may not result in protection in all vaccine and effectivenessof GARDASIL9 havenot been assessed in individuals older than 26 years of AND of gardasil 9 is GARDASIL9 as follows:AgeRegimenSchedule9 through 14 years2-dose0, 6 to 12 months*3-dose0, 2, 6 months15 through 26 years3-dose0, 2, 6 months*If the second dose is administered earlier than 5 months after the first dose,administer athird dose at least 4 months after the second dose.

9 [See Clinical Studies( and ).] of AdministrationFor intramuscular use well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL9 should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL9 is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears GARDASIL9intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the patients for 15 minutes after administration [see Warnings and Precautions (5)].Single-Dose Vial UseWithdraw the dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly. Prefilled Syringe Use This package does not contain a needle. Shake well before use. Attach a needle by twisting in a clockwise direction until the needle fits securely on the syringe.

10 Administer the entire dose as per standard Administration of GARDASIL9 in Individuals Who Have Been Previously Vaccinated with gardasil Safety and immunogenicity were assessed in individuals who completed a three-dose vaccination series with GARDASIL9 and had previously completed a three-dose vaccination series with gardasil [see Adverse Reactions ( ) and Clinical Studies ( )]. Studies using a mixed regimenof HPV vaccines to assess interchangeability were not performed for FORMS AND STRENGTHSGARDASIL9 is a suspension forintramuscular administration available in single-dosevials and prefilled syringes. SeeDescription (11) for the complete listing of , including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL9 or gardasil [see Description (11)].5 WARNINGS AND vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination.