"The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cer"...
- cervical cancer,
- cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and
- cervical intraepithelial neoplasia (CIN) grade 1.
- CERVARIX is approved for use in females 9 through 25 years of age.
Limitations Of Use And Effectiveness
CERVARIX does not provide protection against disease due to all HPV types [see Clinical Studies].
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 [see Clinical Studies].
Females should continue to adhere to recommended cervical cancer screening procedures [see PATIENT INFORMATION].
Vaccination with CERVARIX may not result in protection in all vaccine recipients.
DOSAGE AND ADMINISTRATION
Preparation For Administration
Shake syringe well before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. With thorough agitation, CERVARIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise.
Attach a sterile needle and administer intramuscularly.
Do not administer this product intravenously, intradermally, or subcutaneously.
Dose And Schedule
Immunization with CERVARIX consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm.
Dosage Forms And Strengths
CERVARIX is a suspension for intramuscular injection available in 0.5-mL single-dose prefilled TIP-LOK® syringes.
Storage And Handling
CERVARIX is available in 0.5-mL single-dose disposable prefilled TIP-LOK syringes (packaged without needles):
NDC 58160-830-05 Syringe in Package of 1: NDC 58160-830-34
NDC 58160-830-43 Syringe in Package of 10: NDC 58160-830-52
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Upon storage, a fine, white deposit with a clear, colorless supernatant may be observed. This does not constitute a sign of deterioration.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709
Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Cervarix Information
Cervarix - User Reviews
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