Cervarix (human papillomavirus bivalent vaccine) suspension for injection in pre-filled syringe

Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)

Read all of this leaflet carefully before you start receiving this vaccine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Cervarix (human papillomavirus bivalent vaccine) is and what it is used for
2. Before you receive Cervarix (human papillomavirus bivalent vaccine)
3. How Cervarix (human papillomavirus bivalent vaccine) is given
4. Possible side effects
5. How to store Cervarix (human papillomavirus bivalent vaccine)
6. Further information

1. WHAT CERVARIX (human papillomavirus bivalent vaccine) IS AND WHAT IT IS USED FOR

Cervarix (human papillomavirus bivalent vaccine) is a vaccine intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18.

These diseases include:

• cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb),
• precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into cancer).

Cervarix will not protect against all types of Human Papillomavirus. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases.

When a female is vaccinated with Cervarix (human papillomavirus bivalent vaccine) , the immune system (the body's natural defence system) will make antibodies against HPV types 16 and 18. In clinical trials Cervarix has been shown to prevent HPV types 16 and 18 related diseases in women 15-25 years of age. Cervarix (human papillomavirus bivalent vaccine) also stimulates production of antibodies in females 10-14 years of age.

Cervarix (human papillomavirus bivalent vaccine) is not infectious and so, it cannot cause HPV related diseases.

Cervarix (human papillomavirus bivalent vaccine) is not used to treat HPV related diseases already present at the time of vaccination.

Cervarix (human papillomavirus bivalent vaccine) should be used in accordance with official guidelines.

2. BEFORE YOU RECEIVE CERVARIX (human papillomavirus bivalent vaccine)

Cervarix (human papillomavirus bivalent vaccine) should not be given if

the person to be vaccinated:

• is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Cervarix (human papillomavirus bivalent vaccine) . The active substances and other ingredients of Cervarix (human papillomavirus bivalent vaccine) are listed at the end of the leaflet (see section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to the doctor first.

Take special care with Cervarix (human papillomavirus bivalent vaccine)

You should tell the doctor if the person to be vaccinated:

• has a bleeding problem or bruises easily.
• has any disease which reduces her resistance to infection such as HIV infection

As with all vaccines, Cervarix (human papillomavirus bivalent vaccine) may not fully protect all people who are vaccinated.

Cervarix (human papillomavirus bivalent vaccine) does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.

Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening. You should continue to follow your doctor's advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.

As Cervarix (human papillomavirus bivalent vaccine) will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.

Cervarix (human papillomavirus bivalent vaccine) will not protect against other diseases that are not caused by Human Papillomavirus.

The duration of protection after vaccination is currently unknown. In clinical trials, sustained protection has been observed in females aged 15 to 25 years for up to 6.4 years after the first dose. The need for booster dose(s) has not been investigated.

Using other medicines

Cervarix (human papillomavirus bivalent vaccine) can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.

Cervarix (human papillomavirus bivalent vaccine) 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 (human papillomavirus bivalent vaccine) .

Please tell the doctor if the person to be vaccinated is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.

Pregnancy and breast-feeding

There are insufficient data concerning the use of Cervarix (human papillomavirus bivalent vaccine) during pregnancy. If pregnancy occurs during the course of vaccination your doctor should be consulted. It is recommended to postpone vaccination until after completion of the pregnancy.

Ask your doctor for advice about breast-feeding before receiving Cervarix (human papillomavirus bivalent vaccine) .

Driving and using machines

There is no information on the effect of Cervarix (human papillomavirus bivalent vaccine) on your ability to drive or use machinery.

3. HOW CERVARIX (human papillomavirus bivalent vaccine) IS GIVEN

The doctor or nurse will give Cervarix (human papillomavirus bivalent vaccine) as an injection into the muscle of the upper arm.

Cervarix (human papillomavirus bivalent vaccine) is intended for females from 10 years of age onwards. A total of three injections will be administered by your doctor or nurse according to the following schedule:

First injection: at chosen date

Second injection: 1 month after first injection

Third injection: 6 months after first injection

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

When Cervarix (human papillomavirus bivalent vaccine) is given for the first dose, it is recommended that Cervarix (human papillomavirus bivalent vaccine) (and not another vaccine against HPV) be given for the complete 3-dose vaccination course.

The vaccine should never be given into a vein.

If you forget a return visit for Cervarix (human papillomavirus bivalent vaccine) :

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

If you do not finish the complete vaccination course of three injections, you may not get the best response and protection from the vaccination.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cervarix (human papillomavirus bivalent vaccine) can cause side effects, although not everybody gets them. Side effects that occurred during clinical trials with Cervarix (human papillomavirus bivalent vaccine) were as follows:

• Very common (side effects which may occur in more than 1 per 10 doses of vaccine):
  • pain or discomfort at the injection site
  • redness or swelling at the injection site
  • headache
  • aching muscles, muscle tenderness or weakness (not caused by exercise)
  • tiredness
• Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):
  • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
  • itching, red skin rash, hives (urticaria)
  • joint pain
  • fever ( ≥ 38°C)
• Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine):
  • upper respiratory tract infection (infection of the nose, throat or trachea)
  • dizziness
  • other injection site reactions such as hard lump, tingling or numbness.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CERVARIX (human papillomavirus bivalent vaccine)

Keep out of the reach and sight of children.

Do not use Cervarix (human papillomavirus bivalent vaccine) 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Cervarix (human papillomavirus bivalent vaccine) contains

- The active substances are:

¹Human Papillomavirus = HPV
²adjuvanted by AS04 containing: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)₃........................50 micrograms
³adsorbed on aluminium hydroxide, hydrated (Al(OH)₃)...................0.5 milligrams Al3+ in total
⁴L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni.

• The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH₂PO₄.2 H₂O) and water for injections.

What Cervarix (human papillomavirus bivalent vaccine) looks like and contents of the pack

Suspension for injection in pre-filled syringe.

Cervarix (human papillomavirus bivalent vaccine) is a turbid white suspension.

Cervarix (human papillomavirus bivalent vaccine) is available in pre-filled syringes with or without needles in packs of 1 and 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a., Rue de l'Institut 89, B-1330 Rixensart, Belgium

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last approved in July 2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.

The following information is intended for medical or healthcare professionals only:

Cervarix (human papillomavirus bivalent vaccine) should be administered as soon as possible after being removed from the refrigerator. However, stability data generated indicate that Cervarix (human papillomavirus bivalent vaccine) presented in monodose containers remains stable and can be administered in case it has been stored outside the refrigerator up to three days at temperatures between 8°C and 25°C or up to one day at temperatures between 25°C and 37°C.

A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe. This does not constitute a sign of deterioration.

The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.

The vaccine should be well shaken before use.

Any unused product or waste material should be disposed of in accordance with local requirements.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.