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
Induces development of humeral immune responses against human papillomavirus (HPV).
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).
Hypersensitivity to yeast or any other component of the product.
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.
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.
Immune responses to vaccines may be reduced.
None well documented.
Deep venous thrombosis, pulmonary embolus (postmarketing).
Dizziness (4%); insomnia, malaise (1%); asthenia, fatigue, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope, transverse myelitis (postmarketing).
Nasal congestion (1%).
Nausea (7%); diarrhea (4%); toothache, vomiting (2%); pancreatitis (postmaketing).
Autoimmune hemolytic anemia, lymphadenopathy (postmarketing).
Anaphylactic/anaphylactoid reactions (postmarketing).
Pain (84%); erythema, swelling (25%); bruising, pruritus (3%).
Arthralgia (1%); myalgia (postmarketing).
Cough, upper respiratory tract infection (2%); bronchospasm (postmarketing).
Pyrexia (13%); autoimmune diseases, death (postmarketing).
Because syncope may occur following vaccination, observe patients for 15 min after administration.
Category B .
Safety and efficacy not established in children younger than 9 yr of age.
When possible, avoid use in persons with bleeding disorders such as hemophilia or thrombocytopenia, or in persons receiving anticoagulant therapy.
Reduced antibody response to active immunization may occur.
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.
Adverse reaction profile reported with overdose is comparable with those seen with recommended single doses.
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