Cervarix: Uses, Side Effects and Dosage

What is CERVARIX used for?

CERVARIX is a vaccine intended to protect females against cervical cancer (cancer of the lower part of the uterus or womb) and abnormal and precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into cancer). These diseases are caused by infection with Human Papillomaviruses (HPV) types 16 and 18 and other cancer causing types.

What is cervical cancer?

Cervical cancer is a serious and sometimes life threatening disease. Cervical cancer is caused by HPV infection. There are about 15 types of HPV that cause most cases of cervical cancer. These HPV types can cause the normal cells on the cervix to turn into abnormal precancerous cervical lesions. If left untreated, some of these lesions can turn into cancer over time. Cervical cancer affects females of all ages and among females aged 20 to 44, cervical cancer ranks as the second most common cancer after breast cancer. Cervical cancer screening (i.e., Pap tests) can identify abnormal changes in the cervix that may be treated.

What is Human Papillomavirus (HPV)?

HPV is a common virus which affects humans. The virus is generally spread by skin-to-skin contact during sexual activity. In most cases, females infected with HPV will not have any symptoms and their body will clear the virus. However, the body does not develop long term protection against HPV and must continue to clear new and previously encountered HPV types. Up to 80% of sexually active females will be infected with HPV during their lifetime, which in some cases may cause cervical cancer.

HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers cases. Other HPV types can also cause cervical cancer. CERVARIX provides protection against HPV-16 and HPV-18, although it will not prevent all cancers or precancerous lesions caused by these or other types of HPV.

How does CERVARIX work?

CERVARIX works by stimulating the production of antibodies against HPV types 16 and 18. These antibodies have been shown in clinical trials to protect females aged 15 to 45 years old against HPV-16 and HPV-18 related diseases. In 9 to 14 year old girls, the antibodies produced indicate that they will provide just as much protection as in older women.

• CERVARIX is not infectious and so, it cannot cause HPV related diseases.
• CERVARIX will not treat HPV related diseases already present at time of vaccination.
• If you are currently infected with an HPV-16 or HPV-18 infection, CERVARIX may protect you against the other vaccine type.
• CERVARIX will not protect against diseases that are caused by other infections, including other types of HPV.

Long-Term Protection

In clinical trials, sustained protection has been observed for up to 9.4 years after the first dose. Long-term studies are ongoing to establish the duration of protection.

As with all vaccines, CERVARIX may not fully protect all people who are vaccinated. It is not a substitute for regular cervical screening and you should continue to consult your healthcare professional for regular cervical cancer screening (i.e., Pap tests).

What are the ingredients in CERVARIX?

Medicinal ingredients: Human Papillomavirus type 16 L1 protein and Human Papillomavirus type 18 L1 protein as active substances and is adjuvanted with AS04 adjuvant system [composed of aluminium hydroxide, hydrated and 3-0-desacyl-4’-monophosphoryl lipid A (MPL)]. The adjuvant system is designed to boost the body’s response to CERVARIX leading to long lasting antibody levels. The duration of protection has not been established. CERVARIX is not infectious and so, it cannot cause HPV related diseases.

Non-medicinal ingredients: 3-0-desacyl-4’-monophosphoryl lipid A (MPL), aluminium (as aluminium hydroxide), sodium chloride, sodium dihydrogen phosphate dihydrate, and water for injection.

What is the Adjuvant

An adjuvant is a component added to a vaccine to improve the immune response by providing stronger and longer protection.

Adjuvants have been used in vaccines for almost 80 years. Nearly all vaccines are made with adjuvants. Most common vaccines are designed with traditional adjuvants such as aluminium salts (alum).

The adjuvant system in CERVARIX is AS04 which is made up of 1) a natural compound which comes from a type of organism which most people have been exposed to and 2) alum.

CERVARIX comes in the following dosage forms:

CERVARIX is available as:

• 0.5 mL single-dose pre-filled syringe

Do not use CERVARIX if:

CERVARIX should not be given if you have previously had any allergic reaction to CERVARIX, or any ingredient contained in CERVARIX. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.

Fainting can occur following, or even before, any needle injection, therefore tell your healthcare professional if you have fainted with a previous injection. It is recommended that patients be observed for 15 minutes following vaccine administration.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CERVARIX. Talk about any health conditions or problems you may have, including if you:

• have a severe infection with a high temperature. It is recommended to delay the vaccination where there is a severe infection or fever until recovery. A minor infection such as a cold should not be a problem, but talk to your healthcare professional first.
• have a bleeding problem or bruise easily.

Other warnings you should know about:

Use in children

CERVARIX can be used in children as young as 9 years of age.

Use in pregnancy

Healthcare professionals need to assess the benefits and potential risks of administering the vaccine to pregnant females.

In clinical studies, there was a slightly higher rate of spontaneous abortions in pregnancies which occurred around the time of vaccination in women who were given the CERVARIX vaccine compared with those who received a control vaccine. It is not known if this imbalance is due to CERVARIX.

If pregnancy occurs during the course of vaccination or if you are trying to become pregnant, it is recommended to postpone or interrupt vaccination until after pregnancy. It is also recommended to take adequate precautions to avoid pregnancy for 2 months following vaccination with CERVARIX.

Patients and healthcare providers are encouraged to report any exposure to CERVARIX vaccine during pregnancy by calling 1-800-387-7374.

Use in breastfeeding

Healthcare professionals need to assess the benefits and potential risks of administering the vaccine to breastfeeding females.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with CERVARIX:

CERVARIX can be given at the same time as any one of the following:

• BOOSTRIX-POLIO, a combined diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine.
• BOOSTRIX, a combined diphtheria, tetanus and acellular pertussis vaccine.
• TWINRIX Junior, a combined hepatitis A and hepatitis B vaccine.
• ENGERIX-B (10μg/0.5 mL), a hepatitis B vaccine.
• MENACTRA, a meningococcal groups A, C, Y, W-135 polysaccharide diphtheria toxoid conjugate vaccine.

Ask your healthcare professional for advice about which vaccines may be given at the same time as CERVARIX.

If CERVARIX is to be given at the same time as another injectable vaccine(s), the vaccines should always be given with separate syringes and at different injection sites.

CERVARIX may not have an optimal effect if used with medicines that suppress the immune system.

In clinical trials, oral contraceptives (e.g., the pill) did not reduce the protection obtained by CERVARIX.

How to take CERVARIX:

Usual dose:

Your healthcare professional will give CERVARIX as an injection into the muscle.

You or your daughter will receive a total of three or two injections. If you are 15 to 45 years old, CERVARIX can only be administered according to the 3-dose schedule. If you are between the ages of 9 and 14, your healthcare professional may decide CERVARIX can be given by the 2 dose schedule.

3-dose schedule:

• First injection: at a date chosen by you and your healthcare professional
• Second injection: 1 month after first injection
• Third injection: 6 months after first injection

2-dose schedule:

• First injection: at a date chosen by you and your healthcare professional
• Second injection: 6 months after first injection

If necessary, the vaccination schedule can be more flexible. Please speak to your healthcare professional for more information.

Overdose:

Missed Dose:

It is important that you follow the instructions of your healthcare professional regarding return visits. If you forget to go back to your healthcare professional at the scheduled time, ask your healthcare professional for advice.

If you do not finish the entire vaccination course of three injections, your protection from developing cervical cancer may be reduced.

What are possible side effects from using CERVARIX?

Like all medicines, CERVARIX may cause side effects, although not everybody gets them.

These are not all the possible side effects you may have when taking CERVARIX. If you experience any side effects not listed here, tell your healthcare professional.

You may feel:

• pain or discomfort at the injection site

or you may see some:

• redness or swelling at the injection site

However, these effects usually clear up within a few days.

Other side effects that occurred during clinical trials with CERVARIX were as follows:

Very common (these may occur with more than 1 in 10 doses of the vaccine):

• headache
• aching muscles, muscle tenderness or weakness, not caused by exercise
• fatigue

Common (these may occur with up to 1 in 10 doses of the vaccine):

• gastrointestinal symptoms including nausea, vomiting, diarrhea and abdominal pain
• itching, red skin rash, hives
• joint pain
• fever (≥38°C)

Uncommon (these may occur with up to 1 in 100 doses of the vaccine):

• upper respiratory tract infection
• dizziness
• other injection site reactions such as hard lump, tingling or numbness
• swollen glands in the neck, armpit or groin

Rare (these may occur with up to 1 in 1,000 doses of the vaccine):

• Allergic reactions. These can be recognized by:

  • Itchy rash of the hands and feet
  • Swelling of the eyes and face
  • Difficulty in breathing or swallowing
  • Sudden drop in blood pressure and loss of consciousness

These reactions will usually occur a short time after vaccination. However, if you experience any of these symptoms you should contact a doctor immediately.

• Fainting sometimes accompanied by shaking or stiffness

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

• Do not use CERVARIX after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C – 8°C).
• Do not freeze.
• Store in the original package in order to protect from light.
• Keep out of reach and sight of children.

If you want more information about CERVARIX:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.gsk.ca, or by calling 1-800-387-7374.

Last Revised:

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