DrugindexOnline^{2nd edition}

Pronouncation: (Human pap-i-LOW-ma-VYE-russ Recombinant Vaccine)
Class: Vaccine, viral

Trade Names:
Gardasil
- Solution for injection HPV 6 L1 protein 20 mcg, HPV 11 L1 protein 40 mcg, HPV 16 L1 protein 40 mcg, HPV 18 L1 protein 20 mcg per 0.5 mL

Mechanism of Action

Pharmacology

Induces development of humeral immune responses against human papillomavirus (HPV).

Indications and Usage

Prevention of diseases caused by HPV, including cervical cancer, genital warts (condyloma acuminate), and the following precancerous or dysplastic lesions: cervical adenocarcinoma (in situ), cervical intraepithelial neoplasia (grade 2 and 3), vulvar intraepithelial neoplasia (grade 2 and 3), vaginal intraepithelial neoplasia (grade 2 and 3), and cervical intraepithelial neoplasia (grade 1).

Contraindications

Standard considerations.

Dosage and Administration

Women and girls 9 to 26 yr of age

IM 3 separate 0.5 mL doses, with the second dose given 2 mo after the first dose and the third dose given 6 mo after the first dose.

General Advice

• Administer IM in the deltoid region of the upper arm or the higher anterolateral area of the thigh; do not inject intravascularly, subcutaneously, or intradermally.
• The prefilled syringe is for single use only and should not be used for more than 1 individual.
• For single-use vials, a separate sterile syringe and needle must be used for each individual.
• Use the full recommended dose of the vaccine; no dilution or reconstitution is necessary.
• Shake well before using, which will yield a white cloudy liquid.
• Prior to administration, inspect visually for particulate matter and discoloration. Do not use if product has particulates or appears discolored.

Storage/Stability

Store in refrigerator at 36° to 46°F. Do not freeze. Protect from light.

Drug Interactions

Immunosuppressive therapies (eg, alkylating agents, antimetabolites, corticosteroids, cytotoxic drugs, irradiation)

Immune responses to vaccines may be reduced.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness (4%); insomnia, malaise (1%).

EENT

Nasopharyngitis (6%); nasal congestion (1%).

GI

Nausea (7%); diarrhea (4%); toothache, vomiting (2%).

Local

Pain (84%); erythema, swelling (25%); pruritus (3%).

Musculoskeletal

Myalgia (2%); arthralgia (1%).

Respiratory

Cough, upper respiratory tract infection (2%).

Miscellaneous

Pyrexia (13%).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 9 yr of age.

Elderly

Safety and efficacy not established in adults older than 26 yr of age.

Bleeding disorders

When possible, avoid use in individuals with bleeding disorders such as hemophilia or thrombocytopenia, or in individuals receiving anticoagulant therapy.

Impaired immune responsiveness

Reduced antibody response to active immunization may occur in individuals with impaired immune response, whether due to use of immunosuppressive agents, genetic defect, HIV infection, or other causes.

Patient Information

• Inform patient, parent, or guardian that vaccination is not a substitute for routine cervical cancer screening.
• Provide patient, parent, or guardian with required vaccine information with each vaccination.
• Inform patient, parent, or guardian of the benefits and risks associated with vaccination.
• Inform patient, parent, or guardian that use is not recommended during pregnancy.
• Advise patient, parent, or guardian of the importance of completing the immunization series.
• Instruct patient, parent, or guardian to report any adverse reactions to health care provider.