Active ingredient
- bevacizumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/04/300/002, EU/1/04/300/001.
Avastin 25mg/ml concentrate for solution for infusion
Package leaflet: Information for the user
Avastin 25 mg/ml concentrate for solution for infusion
bevacizumab
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Avastin is and what it is used for
2. What you need to know before you use Avastin
3. How to use Avastin
4. Possible side effects
5. How to store Avastin
6. Contents of the pack and other information
1. What Avastin is and what it is used for
Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer). Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body. The VEGF protein causes blood vessels to grow within tumours, these blood vessels provide the tumour with nutrients and oxygen. Once bevacizumab is bound to VEGF, tumour growth is prevented by blocking the growth of the blood vessels which provide the nutrients and oxygen to the tumour.
Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum. Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Avastin is also used for the treatment of adult patients with metastatic breast cancer. When used for patients with breast cancer, it will be administered with a chemotherapy medicinal product called paclitaxel or capecitabine.
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer. Avastin will be administered together with a chemotherapy regimen containing platinum.
Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR). Avastin will be administered in combination with erlotinib.
Avastin is also used for treatment of adult patients with advanced kidney cancer. When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.
Avastin is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. When used for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, it will be administered in combination with carboplatin and paclitaxel.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back at least 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Avastin will be administered in combination with carboplatin and gemcitabine or with carboplatin and paclitaxel.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Avastin will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
Avastin is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Avastin will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
2. What you need to know before you use Avastin
Do not use Avastin if
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Avastin
Please consult your doctor, even if these above statements were only applicable to you in the past.
Before you are given Avastin or while you are being treated with Avastin:
You may be advised to have a dental check-up before you start treatment with Avastin.
Children and adolescents
Avastin use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with Avastin.
Other medicines and Avastin
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects. Discuss with your doctor to make sure that you do not combine these medicines.
Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer. These therapies in combination with Avastin may increase the risk of severe side effects.
Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Pregnancy, breast feeding and fertility
You must not use this medicine if you are pregnant. Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels. Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Avastin may impair female fertility. Please consult your doctor for more information.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Driving and using machines
Avastin has not been shown to reduce your ability to drive or to use any tools or machines. However, sleepiness and fainting have been reported with Avastin use. If you experience symptoms that affect your vision or concentration, or your ability to react, do not drive and use machines until symptoms disappear.
Important information about some of the ingredients of Avastin
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How to use Avastin
Dosage and frequency of administration
The dose of Avastin needed depends on your body weight and the kind of cancer to be treated. The recommended dose is 5 mg, 7.5 mg, 10 mg or 15 mg per kilogram of your body weight. Your doctor will prescribe a dose of Avastin that is right for you. You will be treated with Avastin once every 2 or 3 weeks. The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing. Your doctor will discuss this with you.
Method and route of administration
Avastin is a concentrate for solution for infusion. Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with sodium chloride solution before use. A doctor or nurse will give you this diluted Avastin solution by intravenous infusion (a drip into your vein). The first infusion will be given to you over 90 minutes. If this is well-tolerated the second infusion may be given over 60 minutes. Later infusions may be given to you over 30 minutes.
The administration of Avastin should be temporarily discontinued
The administration of Avastin should be permanently discontinued if you develop
If too much Avastin is given
If a dose of Avastin is missed
If you stop treatment with Avastin
Stopping your treatment with Avastin may stop the effect on tumour growth. Do not stop treatment with Avastin unless you have discussed this with your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
The side effects listed below were seen when Avastin was given together with chemotherapy. This does not necessarily mean that these side effects were strictly caused by Avastin.
Allergic reactions
If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include: difficulty in breathing or chest pain. You could also experience redness or flushing of the skin or a rash, chills and shivering, feeling sick (nausea) or being sick (vomiting).
You should seek help immediately if you suffer from any of the below mentioned side effects.
Severe side effects, which may be very common (affects more than 1 user in 10), include:
Severe side effects, which may be common (affects 1 to 10 users in 100), include:
Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
You should seek help as soon as possible if you suffer from any of the below mentioned side effects.
Very common (affects more than 1 user in 10) side effects, which were not severe, include:
Common (affects 1 to 10 users in 100) side effects, which were not severe, include:
Patients older than 65 years have an increased risk of experiencing the following side effects :
Avastin may also cause changes in laboratory tests carried out by your doctor. These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs and symptoms of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience any of them.
Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility. If you are considering having children you should discuss this with your doctor before your treatment starts.
Avastin has been developed and made to treat cancer by injecting it into the bloodstream. It has not been developed or made for injection into the eye. It is therefore not authorised to be used in this way. When Avastin is injected directly into the eye (unapproved use), the following side effects may occur:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Avastin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Infusion solutions should be used immediately after dilution. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the infusion solutions have been prepared in a sterile environment. When dilution has taken place in a sterile environment, Avastin is stable for 30 days at 2°C to 8°C plus an additional 48 hours at 2°C to 30°C.
Do not use Avastin if you notice any particulate matter or discolouration prior to administration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Avastin contains
What Avastin looks like and contents of the pack
Avastin is a concentrate for solution for infusion. The concentrate is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper. Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution. Each pack of Avastin contains one vial.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in January 2021
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
uk-pl-avastin-clean-210108-25mg-inf
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