Cervarix

DRUG DESCRIPTION

CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18. The L1 proteins are produced in separate bioreactors using the recombinant Baculovirus expression vector system in a serum-free culture media composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Following replication of the L1 encoding recombinant Baculovirus in Trichoplusia ni insect cells, the L1 protein accumulates in the cytoplasm of the cells. The L1 proteins are released by cell disruption and purified by a series of chromatographic and filtration methods. Assembly of the L1 proteins into virus-like particles (VLPs) occurs at the end of the purification process. The purified, non-infectious VLPs are then adsorbed on to aluminum (as hydroxide salt). The adjuvant system, AS04, is composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) adsorbed on to aluminum (as hydroxide salt).

CERVARIX (human papillomavirus bivalent vaccine) is prepared by combining the adsorbed VLPs of each HPV type together with the AS04 adjuvant system in sodium chloride, sodium dihydrogen phosphate dihydrate, and Water for Injection.

CERVARIX (human papillomavirus bivalent vaccine) is a sterile suspension for intramuscular injection. Each 0.5-mL dose is formulated to contain 20 mcg of HPV type 16 L1 protein, 20 mcg of HPV type 18 L1 protein, 50 mcg of the 3-O-desacyl-4'-monophosphoryl lipid A (MPL), and 0.5 mg of aluminum hydroxide. Each dose also contains 4.4 mg of sodium chloride and 0.624 mg of sodium dihydrogen phosphate dihydrate. Each dose may also contain residual amounts of insect cell and viral protein ( < 40 ng) and bacterial cell protein ( < 150 ng) from the manufacturing process. CERVARIX (human papillomavirus bivalent vaccine) does not contain a preservative.

What are the precautions when taking human papillomavirus bivalent vaccine (Cervarix)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to latex; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), bleeding disorders (such as hemophilia, thrombocytopenia), current fever/illness.

This vaccine can cause some patients to faint, which could cause falling and injury. To reduce the risk of this side effect, your doctor may recommend that you stay in a sitting or lying position for 15 minutes after the injection....

Read All Potential Precautions of Cervarix


Cervarix Consumer (continued)

SIDE EFFECTS: Redness, swelling, and pain at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some patients have fainted after receiving this vaccine. See also Precautions section.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or to latex; or to other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), bleeding disorders (such as hemophilia, thrombocytopenia), current fever/illness.

This vaccine can cause some patients to faint, which could cause falling and injury. To reduce the risk of this side effect, your doctor may recommend that you stay in a sitting or lying position for 15 minutes after the injection. Infrequently, fainting along with seizure-like movements have occurred, and have usually been stopped by placing the patient in a lying position with the face up.

This vaccine is not recommended for use during pregnancy. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.



Related Drugs Index: