Cervarix

What is Cervarix?

• Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine,Recombinant) is a vaccine indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18.

What are the uses of this medicine?

• 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.

Limitations of Use:

• Cervarix does not provide protection against disease due to all HPV types.
• 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.
• Cervarix is not a treatment for HPV.

How does this medicine work?

• Animal studies suggest that the efficacy of L1 VLP vaccines may be mediated by the development of IgG neutralizing antibodies directed against HPV-L1 capsid proteins generated as a result of vaccination.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• allergic reactions (e.g., anaphylaxis) to any component of Cervarix.

What drug interactions can this medicine cause?

• There are no data to assess the concomitant use of Cervarix with other vaccines.
• Do not mix Cervarix with any other vaccine in the same syringe or vial.
• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Cervarix.

Is this medicine FDA approved?

• The FDA approved Cervarix on 16 October 2009.

How should this medicine be used?

Recommended dosage:

• Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection 30 according to the following schedule: 0, 1, and 6 months.
• The preferred site of administration is the deltoid region of the upper arm.

Administration:

• 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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose prefilled syringes containing a 0.5-mL suspension for injection

This medicine is available in fallowing brand namesː

• Cervarix

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain, redness, and swelling where you got the shot
• feeling tired
• headache
• muscle aches
• nausea, vomiting, diarrhea, and stomach pain
• joint aches

Other possible side effects include:

• swollen glands (neck, armpit, or groin).

What special precautions should I follow?

• Because vaccines 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 other seizure-like activity, has been reported following vaccination with Cervarix. When syncope is associated with tonic clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Cervarix is not recommended for use in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients younger than 9 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

Manufactured by:

• GlaxoSmithKline Biologicals
• Rixensart, Belgium

Distributed by:

• GlaxoSmithKline
• Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store refrigerated between 2º and 8ºC (36º and 46ºF).
• 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.

• Dailymed label info on Cervarix
• FDA Cervarix