Details for: CERVARIX
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02342227 | CERVARIX | RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN; RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN | 20 MCG / 0.5 ML; 20 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
Summary Safety Review - Cervarix (Human Papillomavirus vaccine Types 16 and 18 [Recombinant, AS04 adjuvanted]) - Assessing the Potential Risk of a Condition in which the body's defense system damages nerves (Guillain-Barré Syndrome)
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is 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.
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.
What it does
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.
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 health professional for regular cervical cancer screening (i.e. Pap tests).
What is the AdjuvantAn 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.
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.
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.
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.
When it should not be used
Please see Warnings and Precautions section.
What the medicinal ingredient is
CERVARIX contains 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.
What the non-medicinal ingredients are
CERVARIX contains the following nonmedicinal ingredients: 3-0-desacyl-4’-monophosphoryl lipid A (MPL), aluminium (as aluminium hydroxide), sodium chloride, sodium dihydrogen phosphate dihydrate, and water for injection.
What dosage form it comes in
CERVARIX is available as:
- 0.5 mL single-dose pre-filled syringe; or,
- 0.5 mL single-dose vial*
*Format not available in Canada
Warnings and precautions
Serious Warnings and Precautions
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 health care professional if you have fainted with a previous injection. It is recommended that patients be observed for 15 minutes following vaccine administration.
Before you are vaccinated, talk to your health professional 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 health professional first.
- have a bleeding problem or bruise easily
Use in children CERVARIX can be used in children as young as 9 years of age.
Use in pregnancy Health 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 Health professionals need to assess the benefits and potential risks of administering the vaccine to breastfeeding females.
Interactions with this medication
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 (10g/0.5 mL), a hepatitis B vaccine.
- MENACTRA, a meningococcal groups A, C, Y, W135 polysaccharide diphtheria toxoid conjugate vaccine.
Ask your health 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.
Please tell your health professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Proper use of this medication
Usual Dose
Usual dose:
Your health 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 health 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 health professional
- Second injection: 6 months after first injection
If you are 15 to 45 years old, CERVARIX can only be
administered by your doctor according to the 3-dose
schedule.
If necessary, the vaccination schedule can be more flexible.
Please speak to your health professional for more
information.
Overdose
Missed Dose
It is important that you follow the instructions of your health
professional regarding return visits. If you forget to go back
to your health professional at the scheduled time, ask your
health professional for advice.
If you do not finish the entire vaccination course of three
injections, your protection from developing cervical cancer
may be reduced.
Side effects and what to do about them
Like all medicines, CERVARIX may cause side effects, although not everybody gets them.
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
- Fainting sometimes accompanied by shaking or stiffness
These reactions will usually occur a short time after vaccination. However, if you experience any of these symptoms you should contact a doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking CERVARIX, contact your health professional.
How to store
- Keep out of the reach and sight of children.
- 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.
Reporting side effects
To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization.
For health care professionals:
If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory.
For the General Public:
Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form.
If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada:
By toll-free telephone: 1-866-844-0018
By toll-free fax: 1-866-844-5931
E-mail: caefi@phac-aspc.gc.ca
At the following website:
www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
By regular mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
Ottawa, Ontario
K1A 0K9 Address Locator 6502A
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice.
More information
This leaflet is part III of a three-part "Product Monograph" published when CERVARIX was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about CERVARIX. Contact your health professional if you have any questions about the vaccine.
This document plus the full product monograph, prepared for
health professionals can be found at:
www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Last revised: February 15, 2019
© 2019 GSK group of companies or its licensor
Trademarks are owned by or licensed to the GSK group of companies.
MENACTRA is a trademark of Sanofi Pasteur Limited.