Gardasil 9
(L1 protein, human papillomavirus type 11 vaccine / L1 protein, human papillomavirus type 16 vaccine / L1 protein, human papillomavirus type 18 vaccine / L1 protein, human papillomavirus type 31 vaccine / L1 protein, human papillomavirus type 33 vaccine / L1 protein, human papillomavirus type 45 vaccine / L1 protein, human papillomavirus type 52 vaccine / L1 protein, human papillomavirus type 58 vaccine / L1 protein, human papillomavirus type 6 vaccine)Dosage & Administration
For intramuscular administration only.
Each dose of GARDASIL 9 is 0.5-mL
Administer GARDASIL 9 as follows:
| Age | Regimen | Schedule |
|---|---|---|
| 9 through 14 years | 2-dose | 0, 6 to 12 months * |
| 3-dose | 0, 2, 6 months | |
| 15 through 45 years | 3-dose | 0, 2, 6 months |
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Gardasil 9 Prescribing Information
Girls and Women
GARDASIL®9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
- Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers 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
- 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 45 years of age for the prevention of the following diseases:
- Anal, oropharyngeal and other head and neck cancers 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
The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease [see Clinical Studies (14.5)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Limitations of Use and Effectiveness
- Vaccination with GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.
- GARDASIL 9 has not been demonstrated to provide protection against disease caused by:
- HPV types not covered by the vaccine [see Description (11)],
- HPV types to which a person has previously been exposed through sexual activity.
- Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58.
- GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; CIN; VIN; VaIN; or AIN.
- Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
For intramuscular use only
Dosage
Each dose of GARDASIL 9 is 0.5-mL.
Administer GARDASIL 9 as follows:
| Age | Regimen | Schedule |
|---|---|---|
| ||
| 9 through 14 years | 2-dose | 0, 6 to 12 months * |
| 3-dose | 0, 2, 6 months | |
| 15 through 45 years | 3-dose | 0, 2, 6 months |
Method of Administration
- Do not dilute or mix GARDASIL 9 with other vaccines.
- Shake well immediately before use to maintain suspension of the vaccine.
- 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 discolored. After thorough agitation, GARDASIL 9 is a white cloudy liquid.
- Administer intramuscularly in the deltoid or anterolateral area of the thigh.
- Observe patients for 15 minutes after administration [see Warnings and Precautions (5)].
Single-Dose Vial Use
Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly. Discard vial after use.
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. Administer the entire dose as per standard protocol. Discard syringe after use.
Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL®
Safety and immunogenicity were assessed in individuals who completed a three-dose vaccination series with GARDASIL 9 and had previously completed a three-dose vaccination series with GARDASIL [see Adverse Reactions (6.1) and Clinical Studies (14.6)]. Studies using a mixed regimen of HPV vaccines to assess interchangeability were not performed for GARDASIL 9.
GARDASIL 9 is a suspension for intramuscular administration available in 0.5-mL single-dose vials and prefilled syringes. [See Description (11)] for the complete listing of ingredients.
Pregnancy
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no adequate and well-controlled studies of GARDASIL 9 in pregnant women. Data from GARDASIL are relevant to GARDASIL 9 because both vaccines are manufactured using the same process and have overlapping compositions. Data were evaluated from pre-licensure studies in which 55 and 62 pregnancies with known outcomes were associated with women inadvertently exposed to GARDASIL and GARDASIL 9, respectively. Pregnancy Exposure Registry data are available from 1640 and 69 prospectively enrolled women with known pregnancy outcomes who were vaccinated with GARDASIL and GARDASIL 9, respectively. Available data do not suggest an increased risk of major birth defects and miscarriage in women who received GARDASIL or GARDASIL 9.
In one developmental toxicity study, 0.5 mL of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 HPV antigen types was administered to female rats prior to mating and during gestation. In a second study, animals were administered a single human dose (0.5 mL) of GARDASIL 9 prior to mating, during gestation and during lactation. These animal studies revealed no evidence of harm to the fetus due to GARDASIL 9 [see Data].
Data
Human Data
In pre-licensure clinical studies of GARDASIL 9, women underwent pregnancy testing immediately prior to administration of each dose of GARDASIL 9 or control vaccine (GARDASIL). Subjects who were determined to be pregnant were instructed to defer vaccination until the end of their pregnancy. Despite this pregnancy screening regimen, some subjects were vaccinated very early in pregnancy before human chorionic gonadotropin (HCG) was detectable. An analysis was conducted to evaluate pregnancy outcomes for pregnancies with onset within 30 days before or after vaccination with GARDASIL 9 or GARDASIL. Among such pregnancies, there were 62 and 55 with known outcomes (excluding ectopic pregnancies and elective terminations) for GARDASIL 9 and GARDASIL, respectively, including 44 and 48 live births, respectively. The rates of pregnancies that resulted in a miscarriage were 27.4% (17/62) and 12.7% (7/55) in subjects who received GARDASIL 9 or GARDASIL, respectively. The rates of live births with major birth defects were 0% (0/44) and 2.1% (1/48) in subjects who received GARDASIL 9 or GARDASIL, respectively.
A six-year pregnancy registry for GARDASIL 9 enrolled 185 women who were exposed to GARDASIL 9 within one month prior to the last menstrual period (LMP) or at any time during pregnancy, 180 of whom were prospectively followed. After excluding elective terminations (n=1), ectopic pregnancies (n=0) and those lost to follow-up (n=110), there were 69 pregnancies (including one twin pregnancy) with known outcomes. Of the 69 pregnancies, 5 were in women exposed twice during pregnancy. Therefore, there were 74 exposures to GARDASIL 9 during pregnancy: 3 occurred during the 30 days prior to LMP, 34 during the first trimester, 13 during the second trimester, 19 during the third trimester, and 5 in an unknown trimester. Adverse pregnancy outcomes included 3 miscarriages (all in pregnancy exposures during the first trimester) and 3 major birth defects (one each for pregnancy exposure during the 30 days prior to LMP, first trimester, and second trimester). Women who were exposed twice during pregnancy had 0 miscarriages and 0 major birth defects. These data do not suggest an increased risk of major birth defects and miscarriage in women who received GARDASIL 9.
A five-year pregnancy registry enrolled 2,942 women who were exposed to GARDASIL within one month prior to the LMP or at any time during pregnancy, 2,566 of whom were prospectively followed. After excluding elective terminations (n=107), ectopic pregnancies (n=5) and those lost to follow-up (n=814), there were 1,640 pregnancies with known outcomes. Rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1,640) and 2.4% of live born infants (37/1,527), respectively. These rates of assessed outcomes in the prospective population were consistent with estimated background rates.
In two postmarketing studies of GARDASIL (one conducted in the U.S., and the other in Nordic countries), pregnancy outcomes among subjects who received GARDASIL during pregnancy were evaluated retrospectively. Among the 1,740 pregnancies included in the U.S. study database, outcomes were available to assess the rates of major birth defects and miscarriage. Among the 499 pregnancies included in the Nordic study database, outcomes were available to assess the rates of major birth defects. In both studies, rates of assessed outcomes did not suggest an increased risk with the administration of GARDASIL during pregnancy.
Animal Data
Developmental toxicity studies were conducted in female rats. In one study, animals were administered 0.5 mL of a vaccine formulation containing between 1 and 1.5 –fold of each of the 9 HPV antigen types 5 and 2 weeks prior to mating, and on gestation day 6. In a second study, animals were administered a single human dose (0.5 mL) of GARDASIL 9, 5 and 2 weeks prior to mating, on gestation day 6, and on lactation day 7. No adverse effects on pre- and post-weaning development were observed. There were no vaccine-related fetal malformations or variations, or effects on female fertility.
Lactation
Risk Summary
Available data are not sufficient to assess the effects of GARDASIL 9 on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for GARDASIL 9 and any potential adverse effects on the breastfed child from GARDASIL 9 or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients below 9 years of age.
Geriatric Use
The safety and effectiveness of GARDASIL 9 have not been evaluated in a geriatric population, defined as individuals aged 65 years and over.
Immunocompromised Individuals
The immunologic response to GARDASIL 9 may be diminished in immunocompromised individuals [see Drug Interactions (7.1)].
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL [see Description (11)].
Syncope
Because 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.
Managing Allergic Reactions
Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of GARDASIL 9.