"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"...
(SERV-ah-rix) [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant]
Read this Patient Information carefully before getting CERVARIX. You (the person getting CERVARIX) will need 3 doses of the vaccine. Read this information before each dose of CERVARIX. This information does not take the place of talking with your healthcare provider about CERVARIX.
What is CERVARIX?
- CERVARIX is a vaccine given by injection (shot) to girls and women 9 through 25 years of age.
- CERVARIX helps protect against cervical cancer and precancers caused by human papillomavirus (HPV) types 16 and 18.
- There are many types of HPV but only certain types cause cervical cancer. HPV types 16 and 18 are the 2 most common types of HPV that lead to cervical cancer and precancers.
- Abnormal Pap smear results can indicate the presence of precancers. Some precancers can lead to cervical cancer.
- CERVARIX is not a treatment for HPV.
- You can not get HPV diseases from CERVARIX.
What important information should I know about CERVARIX?
- You should continue to get routine cervical cancer screening (such as a Pap smear).
- CERVARIX may not fully protect everyone who gets the vaccine.
- Not all cervical cancers are caused by the HPV types CERVARIX protects against. CERVARIX will not protect against diseases from all HPV types.
- CERVARIX will not protect against HPV types that you already have.
Who should not get CERVARIX?
You should not get CERVARIX if you have or have had:
- an allergic reaction to a previous dose of CERVARIX.
- an allergy to any of the ingredients in CERVARIX (listed below).
What should I tell my healthcare provider before getting CERVARIX?
Tell your healthcare provider about all your health conditions, including if you:
- have had an allergic reaction after a previous dose of CERVARIX.
- have an allergy to latex.
- have a weakened immune system.
- are taking any other medicine or have recently gotten any other vaccine.
- have a fever over 100°F (37.8°C).
- are pregnant or are planning to get pregnant during the time period of the 3 shots. CERVARIX is not recommended for use in pregnant women.
Pregnancy Registry: If you are vaccinated during pregnancy, there is a registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll in the registry by calling 1-888-452-9622.
Your healthcare provider will decide if you should get CERVARIX.
How is CERVARIX given?
CERVARIX is given as an injection (shot) in a muscle in your arm.
You will need a total of 3 shots as follows:
- First dose: given at a time decided by you and your healthcare provider
- Second dose: given 1 month after the first dose
- Third dose: given 6 months after the first dose
Fainting may occur, sometimes resulting in falling with injury, especially in young females. Your healthcare provider may ask you to sit or lie down for 15 minutes after you get CERVARIX. Some people who faint may shake or become stiff. If this happens, it may require evaluation or treatment by your healthcare provider.
Make sure you get all 3 doses on time for the best protection. If you miss a scheduled dose, talk to your healthcare provider.
What are the possible side effects of CERVARIX?
The most common side effects of CERVARIX are:
- pain, redness, and swelling where you got the shot
- feeling tired
- muscle aches
- nausea, vomiting, diarrhea, and stomach pain
- joint aches
Other possible side effects include:
- swollen glands (neck, armpit, or groin).
Call your healthcare provider or seek medical treatment immediately if you develop hives, difficulty breathing, or swelling of the throat, because these may be signs of a severe allergic reaction.
Tell your healthcare provider about these or any other side effects that concern you. For a more complete list of side effects, ask your healthcare provider.
What are the ingredients in CERVARIX?
CERVARIX contains proteins of HPV types 16 and 18. The vaccine also contains 3- O-desacyl-4'-monophosphoryl lipid A (MPL), aluminum hydroxide, sodium chloride, and sodium dihydrogen phosphate dehydrate.
CERVARIX contains no preservatives.
This is a summary of information about CERVARIX. If you would like more information, please talk with your healthcare provider or visit www.cervarix.com.
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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