Human Papillomavirus Quadrivalent Vaccine, Recombinant

Trade Names:
Gardasil
- Suspension for injection Each 5 mL dose contains: HPV 6 L1 protein 20 mcg, HPV 11 L1 protein 40 mcg, HPV 16 L1 protein 40 mcg, HPV 18 L1 protein 20 mcg

Pharmacology

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

Indications and Usage

Prevention, in girls and women 9 through 26 yr of age, of diseases caused by HPV, including cervical, vulvar and vaginal 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

Hypersensitivity to yeast or any other component of the product.

Dosage and Administration

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.
• Do not dilute or mix with other vaccines.
• Shake well immediately 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. Can be out of refrigeration at temperatures at or below 77°F for not more than 72 h.

Drug Interactions

Immune responses to vaccines may be reduced.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Deep venous thrombosis, pulmonary embolus (postmarketing).

CNS

Dizziness (4%); insomnia, malaise (1%); asthenia, fatigue, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope, transverse myelitis (postmarketing).

Dermatologic

Urticaria (postmarketing).

EENT

Nasal congestion (1%).

GI

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

Hematologic-Lymphatic

Autoimmune hemolytic anemia, lymphadenopathy (postmarketing).

Hypersensitivity

Anaphylactic/anaphylactoid reactions (postmarketing).

Local

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

Musculoskeletal

Arthralgia (1%); myalgia (postmarketing).

Respiratory

Cough, upper respiratory tract infection (2%); bronchospasm (postmarketing).

Miscellaneous

Pyrexia (13%); autoimmune diseases, death (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

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

Bleeding disorders

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

Impaired immune responsiveness

Reduced antibody response to active immunization may occur.

Limitations

Does not provide protection against disease from vaccine and nonvaccine HPV types to which patient has previous exposure through sexual activity; not intended for treatment of active genital warts, or cervical, vulvar, and vaginal cancer; does not protect against diseases due to HPV types not contained in the vaccine; protects only against those vulvar and vaginal cancers caused by HPV 16 and 18; does not protect against genital diseases not caused by HPV; may not result in protection in all vaccine recipients.

Overdosage

Symptoms

Adverse reaction profile reported with overdose is comparable with those seen with recommended single doses.

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.

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