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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use CERVARIX safely and effectively. See full prescribing information for CERVARIX.
CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant]
Suspension for Intramuscular Injection
Initial U.S. Approval: 2009
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RECENT MAJOR CHANGES
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Indications and Usage (1) |
07/2011 |
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Warnings and Precautions, Latex (5.2) |
07/2011 |
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INDICATIONS AND USAGE
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CERVARIX is a vaccine indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18:
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cervical cancer,
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cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and
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cervical intraepithelial neoplasia (CIN) grade 1. (1.1)
CERVARIX is approved for use in females 9 through 25 years of age.
Limitations of Use and Effectiveness (1.2)
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CERVARIX does not provide protection against disease due to all HPV types. (14.3)
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CERVARIX has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. (14.2)
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DOSAGE AND ADMINISTRATION
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Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months. (2.2)
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DOSAGE FORMS AND STRENGTHS
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0.5-mL suspension for injection as a single-dose vial or prefilled syringe. (3)
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CONTRAINDICATIONS
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Severe allergic reactions (e.g., anaphylaxis) to any component of CERVARIX. (4)
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WARNINGS AND PRECAUTIONS
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Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and oth
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