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Human Papillomavirus Vaccine
GARDASIL®
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FDA Approval: |
June 2006 |
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Indication: |
Prevention of human papillomavirus-associated diseases (cervical
cancer; genital warts; cervical adenocarcinoma; cervical, vaginal,
vulvar intraepithelial neoplasia) in 9- to 26-year-old females |
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Pharmacology: |
Recombinant vaccine - HPV types 6, 11, 16, 18 |
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Usual Dose: |
0.5 mL IM once, followed by 0.5 mL IM 2 and 6 months later |
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Contraindications: |
Hypersensitivity to any ingredient Further doses should not be
given if allergic symptoms occur |
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Warnings: |
May not protect all vaccinees; does not protect against non-vaccine
HPV types Not indicated for treatment of active disease
Reduced antibody response may occur in immunosuppressed patients
IM injections should be avoided in patients with bleeding
disorders or on anticoagulant treatment unless benefit outweighs
risk
Not recommended during pregnancy; caution recommended during
lactation
Safety and efficacy not established in patients younger than 9
years or older than 26 years |
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Pregnancy Category: |
B |
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Side Effects: |
Injection site pain, swelling, erythema, pruritus Fever, nausea,
nasopharyngitis, dizziness, diarrhea, vomiting, myalgia, cough,
toothache, upper respiratory infection, malaise, arthralgia,
insomnia, nasal congestion |
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Drug Interactions: |
Immunosuppressants |
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Copyright 2006-2007 Cerner Multum, Inc.
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