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Prevention of human papillomavirus infection:
Females 9 to 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
For the prevention of the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Cervical intraepithelial neoplasia (CIN) grades 1, 2, and 3
Cervical adenocarcinoma in situ (AIS)
Vulvar intraepithelial neoplasia (VIN) grades 2 and 3
Vaginal intraepithelial neoplasia (VaIN) grades 2 and 3
Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3
Males 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
For the prevention of 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
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for females and males 11 to 12 years of age; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age. Catch-up vaccination is recommended for females 13 to 26 years of age and males 13 to 21 years of age. Vaccination for males 22 through 26 years of age is recommended if immunocompromised (including HIV) and for men who have sex with men and may be considered for any other male in this age group (ACIP [Robinson 2016]; CDC/ACIP [Petrosky 2015]).
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of this vaccine or human papillomavirus vaccine (recombinant) for types 6, 11, 16, 18
Immunization: Adults ≤26 years: IM: 0.5 mL at 0, 2, and 6 months
CDC/ACIP recommended immunization schedule: 0.5 mL per dose for a total of 3 doses; administer the second and third doses at 2 and 6 months after initial dose. There should be a 1-month minimum interval between the first and second dose; a 3-month minimum interval between the second and third dose; a 6-month minimum interval between the first and third dose. Begin series in females ≤26 years or males ≤21 years if not previously vaccinated or completed the 3-dose series (typically administer first dose at age 11 to 12 years). Vaccination for males 22 through 26 years of age is recommended if immunocompromised (including HIV) and for men who have sex with men and may be considered for any other male in this age group. Second and third doses may be given after age 26 years to complete a previously initiated series (CDC/ACIP [Petrosky 2015]).
Immunization: Children ≥9 years and Adolescents: IM: 0.5 mL at 0, 2, and 6 months
CDC/ACIP recommended immunization schedule: Children ≥9 years and Adolescents: IM: 0.5 mL per dose for a total of 3 doses administered as follows: Initial dose followed by a second dose at 1 to 2 months after initial and third doses at 6 months after the initial. Administer first dose at age 11 to 12 years; for patients with any history of sexual abuse or assault, vaccination should be started at 9 years of age. Minimum interval between first and second doses is 4 weeks; the minimum interval between the second and third dose is 12 weeks; the minimum interval between first and third doses is 24 weeks; begin series in females ages 13 to 26 years or males 13 to 21 years if not previously vaccinated or who have not completed the 3-dose series. Males may also be vaccinated 22 through 26 years of age. Second and third doses may be given after age 26 years to complete a previously initiated series (ACIP [Robinson 2016]; CDC/ACIP [Petrosky 2015]).
There are no dosage adjustments provided in the manufacturer 's labeling.
There are no dosage adjustments provided in the manufacturer 's labeling.
Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. After thorough agitation, the HPV vaccine is a white, cloudy liquid. Use promptly.
Shake suspension well before use. Do not use if discolored or if contains particulate matter, or if syringe is cracked. Inject the entire dose IM into the deltoid region of the upper arm or higher anterolateral thigh area. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering persons name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (NCIRD/ACIP 2011).
Store refrigerated at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F). Do not freeze. Protect from light.
Administer as soon as possible after being removed from refrigeration. HPV 9-valent vaccine can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8 ‚ °C and 25 ‚ °C) does not exceed 72 hours. Cumulative multiple excursions between 0 ‚ °C and 2 ‚ °C are also permitted as long as the total time between 0 ‚ °C and 2 ‚ °C does not exceed 72 hours. These are not, however, recommendations for storage.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular [preservative free]:
Gardasil 9: (0.5 mL) [contains polysorbate 80, yeast extract]
Suspension Prefilled Syringe, Intramuscular [preservative free]:
Gardasil 9: (0.5 mL) [contains polysorbate 80, yeast extract]
Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.
Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Screening for HPV is not required prior to vaccination. Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion. Continue recommended anal cancer screening.
Females: Gynecologic screening exam, papillomavirus test; screening for cervical cancer should continue per current guidelines following vaccination
To report suspected adverse reactions, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at (877) 888-4231 or VAERS at (800) 822-7967 or http://www.vaers.hhs.gov.
Frequency not always defined. Reported incidences are for individuals (females 9 to 26 years of age and males 9 to 15 years of age) who the vaccine is approved for use, unless otherwise specified by a specific population.
>10%:
Central nervous system: Headache (9% to 20%)
Local: Pain at injection site (63% to 90%), swelling at injection site (13% to 49%; swelling increased with successive doses and/or concomitant vaccines), erythema at injection site (7% to 42%; erythema increases with successive doses)
1% to 10%:
Cardiovascular: Syncope
Central nervous system: Dizziness ( ≤3%), fatigue ( ≤2%)
Gastrointestinal: Diarrhea ( ≤1%), upper abdominal pain ( ≤2%), nausea (1% to 4%)
Immunologic: Autoimmune disease (2%)
Local: Itching at injection site (4% to 8%), hematoma at injection site (1% to ≤5%), bruising at injection site (2%), induration at injection site (1% to ≤2%), bleeding at injection site (1%), injection site nodule (1%), injection site reaction ( ≤1%)
Neuromuscular & skeletal: Myalgia ( ≤1%)
Respiratory: Oropharyngeal pain (1% to 3%)
Miscellaneous: Fever (4% to ≤10%)
<1% (Limited to important or life-threatening): Anaphylactoid reaction, hypersomnia, postural orthostatic tachycardia, status asthmaticus, tonsillitis
Concerns related to adverse effects:
- Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (NCIRD/ACIP 2011).
- Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).
Disease-related concerns:
- Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP 2011).
- Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).
- Human papillomavirus (HPV) infection: There is no evidence that individuals already infected with HPV will be protected; those already infected with 1 or more HPV types were protected from disease caused by the remaining HPV types. Not for the treatment of active disease; will not protect against diseases not caused by HPV vaccine types not included in the vaccine. Does not eliminate the necessity for recommended cervical or anal cancer screenings.
Concurrent drug therapy issues:
- Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (NCIRD/ACIP 2011).
Special populations:
- Altered immunocompetence: Use with caution in severely immunocompromised patients (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).
Dosage form specific issues:
- Yeast: Product may contain yeast.
- Previously vaccinated with Gardasil (quadrivalent): Safety and immunogenicity of Gardasil 9 were assessed in individuals who previously completed a 3-dose vaccination series with Gardasil (quadrivalent). Studies using a mixed regimen of HPV vaccines to assess interchangeability were not performed. Per the ACIP, if the provider does not have available or does not know the HPV product used previously, any gender appropriate product can be used to complete the series (CDC/ACIP [Petrosky 2015]).
Other warnings/precautions:
- Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Adult Recommended Immunization Schedule (ACIP [Kim 2016]). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014).
- Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP 2011).
- Maximum efficacy: The entire 3-dose regimen should be completed for maximum efficacy.
B
Adverse events were not observed in animal reproduction studies. In clinical trials, women who were found to be pregnant before the completion of the 3-dose regimen were instructed to defer any remaining dose until pregnancy resolution. In pregnancies detected within 30 days of vaccination, no cases of congenital abnormalities were noted. Pregnancies with onset beyond 30 days of vaccination had a rate of congenital anomalies consistent with the general population. Administration of the vaccine in pregnancy is not recommended. Until additional information is available, the vaccine series (or completion of the series) should be delayed until pregnancy is completed. Pregnancy testing is not required prior to administration of the vaccine (CDC/ACIP [Petrosky 2015]).
A registry has been established for women exposed to the Gardasil 9 HPV vaccine during pregnancy (1-800-986-8999).
Contains inactive human papillomavirus (HPV) proteins (types 6 L1,11 L1, 16 L1, 18 L1, 31 L1, 33 L1, 45 L1, 52 L1, and 58 L1) which produce neutralizing antibodies to prevent cervical, vulvar, vaginal, and anal cancers, cervical adenocarcinoma, cervical, vaginal, vulvar, and anal neoplasia, and genital warts caused by HPV. Efficacy of HPV 9-valent vaccine against anogenital diseases related to the vaccine HPV types in humans is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience headache, nausea, diarrhea, pharyngitis, or injection site pain or irritation. Have patient report immediately to prescriber signs of skin infection, severe dizziness, passing out, difficulty with motor activity, seizures, joint pain, enlarged lymph nodes, severe loss of strength and energy, confusion, chills, leg pain, shortness of breath, angina, muscle pain, muscle weakness, severe abdominal pain, bruising, or bleeding (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.