Prevention of Disease Caused by Human Papillomavirus (HPV)
Prevention of genital warts (condyloma acuminata), cervical cancer, and precancerous or dysplastic lesions (e.g., cervical adenocarcinoma in situ [AIS], cervical intraepithelial neoplasia [CIN] grades 1, 2, and 3, vulvar intraepithelial neoplasia [VIN] grades 2 and 3, vaginal intraepithelial neoplasia [VaIN] grades 2 and 3) caused by HPV types 6, 11, 16, and 18 in females 9–26 years of age.
Genital HPV is the most common sexually transmitted infection in the US. Most genital HPV infections are asymptomatic and transient, but some high-risk HPV types may cause abnormal cells on the cervical lining that evolve into cancer.
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, American Academy of Family Physicians (AAFP), and American College of Obstetricians and Gynecologists (ACOG) recommend that all females 9–26 years of age receive a 3-dose series of quadrivalent HPV vaccine, unless contraindicated. (See Contraindications under Cautions.)
Ideally, HPV vaccine should be administered before potential exposure to HPV occurs through sexual activity; however, age-appropriate females who are already sexually active should be vaccinated.
May be used in females 9–26 years of age with or without prior exposure to HPV, equivocal or abnormal Papanicolaou (Pap) tests, positive HPV DNA tests (Hybrid Capture 2® [HC2] high-risk test), or genital warts.
There is no evidence that vaccination has any beneficial effects on preexisting Pap test abnormalities or on preexisting HPV infection or genital warts (including those caused by HPV types represented in the vaccine). However, vaccination provides protection against infection with vaccine HPV types not already acquired.
Does not prevent infection or disease caused by HPV types not represented in the vaccine.
Does not prevent non-HPV related cervical disease.
Not used for treatment of active genital warts, cervical cancer, or precancerous genital lesions (i.e., CIN, VIN, or VaIN).
Safety and efficacy not established in females <9 years of age or >26 years of age. Efficacy studies have been initiated in females >26 years of age.
Safety and efficacy not established in males of any age. Efficacy studies have been initiated in adolescent boys and adult men.
Dosage and Administration
Administration
IM Administration
Administer by IM injection.
Do notadminister sub-Q, intravascularly, or intradermally.
Shake vaccine well immediately prior to administration to provide a uniform, white, cloudy suspension. Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.
Administer in the deltoid region of the upper arm or in the anterolateral aspect of the upper thigh. To ensure delivery of vaccine into the muscle, IM injections should be made at a 90° angle to the skin using a needle size that is appropriate for the individual.
Administer undiluted; do not mix with any other vaccine or solution.
Observe vaccinee for approximately 15 minutes following administration of the vaccine since syncope has occurred.
May be given simultaneously with other age-appropriate vaccines during the same health-care visit (using different syringes and different injection sites). (See Interactions.)
When multiple vaccines are administered during a single health-care visit, each vaccine should preferably be given at a different anatomic site. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
Dosage
Pediatric Patients
Prevention of Disease Caused by Human Papillomavirus (HPV)
Female Children and Adolescents 9–18 Years of Age
IM
Primary immunization consists of a series of 3 doses. Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose vial or prefilled syringe.
Give initial dose at ≥9 years of age and give second and third doses 2 and 6 months, respectively, after initial dose.
ACIP, AAP, AAFP, and ACOG recommend that the first dose be given routinely to all girls at 11–12 years of age, but first dose may be given to girls as young as 9 years of age at the discretion of the clinician.
Catch-up vaccination recommended for all female children and adolescents 13–18 years of age who have not previously received the complete 3-dose series. Give second dose 4 weeks after first dose and give third dose 12 weeks after second dose (not earlier than 6 months after first dose).
Duration of immunity following the recommended 3-dose vaccine series not fully determined. (See Duration of Immunity under Cautions.) Additional (booster) doses not recommended.
Adults
Prevention of Disease Caused by Human Papillomavirus (HPV)
Adult Women 19–26 Years of Age
IM
Primary immunization consists of a series of 3 doses. Each dose consists of the entire contents (0.5 mL) of the commercially available single-dose vial or prefilled syringe.
In previously unvaccinated adult women, give initial dose at 19–26 years of age and give the second and third doses 2 and 6 months, respectively, after initial dose.
Catch-up vaccination recommended for all adult women ≤26 years of age who are unvaccinated or incompletely vaccinated. Give second and third doses 2 and 6 months, respectively, after initial dose.
Duration of immunity following the recommended 3-dose vaccine series not fully determined. (See Duration of Immunity under Cautions.) Additional (booster) doses not recommended.
Special Populations
Hepatic Impairment
No specific dosage recommendations.
Renal Impairment
No specific dosage recommendations.
Geriatric Patients
Safety and efficacy not established in adults >26 years of age, including geriatric adults.
Cautions
Contraindications
Known hypersensitivity to any vaccine component or to yeast. (See Hypersensitivity Reactions under Cautions.)
Do notgive additional doses to individuals who experienced symptoms suggestive of hypersensitivity following a previous dose.
Quadrivalent HPV vaccine is manufactured using Saccharomyces cerevisiae (yeast). Data from the Vaccine Adverse Event Reporting System (VAERS) indicate that recombinant yeast-derived vaccines pose a minimal risk for anaphylactic reactions in individuals with a history of allergic reactions to yeast.
As with any vaccine, have epinephrine and other appropriate agents readily available in case an anaphylactic reaction occurs following administration of the vaccine.
General Precautions
Limitations of Vaccine Effectiveness
May not protect all vaccine recipients against HPV infection.
Duration of Immunity
Duration of immunity following the 3-dose vaccine series of quadrivalent HPV vaccine and need for additional (booster) doses not fully determined. Data to date suggest the vaccine induces high-titer anti-HPV antibody levels and efficacy for prevention of disease caused by HPV types 6, 11, 16, and 18 is maintained for at least 5 years.
Concomitant Illness
A decision to administer or delay vaccination in an individual with a current or recent acute illness depends on the severity of symptoms and etiology of the illness.
ACIP states that quadrivalent HPV vaccine may be administered to age-appropriate females with minor acute illnesses such as diarrhea or mild upper respiratory tract infection (with or without fever), but defer vaccination in those with moderate or severe acute illness (with or without fever).
Individuals with Altered Immunocompetence
May be administered to individuals immunosuppressed as a result of disease (e.g., congenital immunodeficiency, HIV infection, hematologic or generalized malignancy) or immunosuppressive therapy. Consider possibility that the immune response to the vaccine and efficacy may be reduced in these individuals.
ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the vaccine can be administered with reasonable safety. In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.
Improper Storage and Handling
Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.
Do not administer quadrivalent HPV vaccine that has been mishandled or has not been stored at the recommended temperature (2–8°C). (See Storage under Stability.)
Quadrivalent HPV vaccine contains an aluminum adjuvant that may precipitate if the vaccine is exposed to freezing temperatures (≤0° C).
Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.
Specific Populations
Pregnancy
Category B.
ACIP, AAFP, and ACOG state that quadrivalent HPV vaccine is not recommended for use in pregnant women.
Delay initiation of the 3-dose vaccine series until pregnancy is completed. If a woman is found to be pregnant after initiation of the series, defer any remaining doses until after completion of the pregnancy.
Pregnancy registry at 800-986-8999. Clinicians or vaccinees should report any exposure to the vaccine that occurs during pregnancy.
Lactation
Not known whether antigens contained in quadrivalent HPV vaccine or antibodies induced by the vaccine are distributed into milk.
ACIP and CDC state the vaccine may be used in nursing women. Manufacturer recommends caution.
Pediatric Use
Safety and efficacy not established in children <9 years of age.
Geriatric Use
Safety and efficacy not established in adults >26 years of age, including geriatric adults.
Quadrivalent HPV vaccine is a noninfectious recombinant vaccine; interactions with other recombinant vaccines, live virus vaccines, inactivated vaccines, or toxoids are unlikely. Simultaneous administration with other age-appropriate vaccines (e.g., meningococcal vaccine, tetanus toxoid and reduced diphtheria toxoid and acellular pertussis vaccine adsorbed [Tdap]) during the same health-care visit is not expected to affect immunologic responses or adverse reactions to any of the vaccines. However, each vaccine should be given using a different syringe and different injection site.
Concomitant administration of the complete primary immunization series (3 doses each) of quadrivalent HPV vaccine and HepB vaccine (at different injection sites) during the same health-care visits in women 16–23 years of age did not decrease the antibody response to either vaccine and did not increase the incidence of clinically important adverse effects compared with administration during separate visits
May be administered concomitantly (using different syringes and different injection sites)
Potential for decreased antibody response to vaccines
Stability
Storage
Parenteral
Suspension, for IM Use
2–8°C. Protect from light and freezing.
Quadrivalent HPV vaccine does not contain thimerosal or any other preservatives.
Actions
Quadrivalent HPV vaccine is a suspension of virus-like particles (VLPs) of the major capsid (L1) proteins of 4 HPV types (i.e., 6, 11, 16, 18) that commonly infect humans.
The vaccine L1 VLPs are structurally indiscernible from native HPV virions and stimulate active immunity to the HPV types represented in the vaccine. The VLPs do not contain DNA and are noninfectious.
Vaccination with a 3-dose series of quadrivalent HPV vaccine can prevent infection with HPV types 6, 11, 16, and 18 and prevent genital warts, cervical cancer, and precancerous genital lesions caused by these HPV types.
HPV types 6 and 11 cause about 90% of all cases of genital warts and HPV types 16 and 18 cause about 70% of all cases of cervical cancer, AIS, CIN 3, VIN 2/3, and VaIN 2/3 and 50% of all cases of CIN 2.
Data indicate that 99.1–100% of all female vaccine recipients 9–26 years of age develop antibodies to HPV types 6, 11, 16, and 18 by 1 month following the third dose of quadrivalent HPV vaccine. In clinical trials, mean antibody titers of anti-HPV 6, 11, 16, and 18 peaked in vaccinees at 1 month following the third vaccine dose.
Minimum antibody titers that provide protection against infection with HPV types 6, 11, 16, and 18 not established to date.
Advice to Patients
Provide copy of manufacturer's patient information to the patient and/or patient's parent or guardian. Prior to administration of each vaccine dose, also provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at http://www.cdc.gov/vaccines/pubs/vis/default.htm).
Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with quadrivalent HPV vaccine.
Advise patient and/or patient's parent or guardian that vaccination with quadrivalent HPV vaccine does not substitute for routine cervical cancer screening. Vaccine recipients should continue to receive routine cervical cancer screening (e.g., Pap tests) according to the usual standard of care.
Advise patient and/or patient's parent or guardian that vaccination with quadrivalent HPV vaccine will not protect against disease due to HPV types not represented in the vaccine or against non-HPV-related cervical disease.
Advise vaccine recipients to continue to practice behaviors that limit the risk of HPV exposure (e.g., abstinence, monogamy, limited number of sexual partners, use of condoms).
Advise patient they should not receive quadrivalent HPV vaccine if they have had a life-threatening allergic reaction to a previous dose or to yeast or any other vaccine component.
Importance of informing clinicians if the patient has any illness with fever >37.8°C, a bleeding disorder, or a weakened immune system (e.g., genetic defect, HIV/AIDS).
Importance of completing the 3-dose vaccination series of quadrivalent HPV vaccine, unless contraindicated.
Importance of contacting clinicians if a hypersensitivity reaction (difficulty breathing, hoarseness, wheezing, hives, paleness, weakness, fast heart beat, dizziness) or other moderate or severe reaction (high fever, behavior changes) occurs following a vaccine dose. Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or http://www.vaers.hhs.gov/.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Advise vaccine recipients that HPV vaccine is not recommended for use in pregnant women. If any exposure to HPV vaccine occurs during pregnancy, vaccinees and their clinicians are encouraged to contact the pregnancy registry at 800-986-8999.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Recombinant virus-like particle (VLP) of the major capsid (L1) protein of human papillomavirus (HPV) content: 20 mcg of HPV type 6 L1, 40 mcg of HPV type 11 L1, 40 mcg of HPV type 16 L1, and 20 mcg of HPV type 18 L1 protein per 0.5 mL
Gardasil® (amorphous aluminum hydroxyphosphate sulfate adjuvant approximately 225 mcg of aluminum per 0.5 mL; preservative-free; available in single-dose vials and prefilled disposable syringes)
Merck
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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