This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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 is: PLGB 45613/0013.
Aybintio 25 mg/ml concentrate for solution for infusion
Aybintio® 25 mg/ml concentrate for solution for infusion
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Aybintio is and what it is used for
2. What you need to know before you use Aybintio
3. How to use Aybintio
4. Possible side effects
5. How to store Aybintio
6. Contents of the pack and other information
Aybintio 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.
Aybintio is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum. Aybintio will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Aybintio 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.
Aybintio is also used for the treatment of adult patients with advanced non-small cell lung cancer. Aybintio will be administered together with a chemotherapy regimen containing platinum.
Aybintio 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).
Aybintio will be administered in combination with erlotinib.
Aybintio 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.
Aybintio 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, Aybintio 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, Aybintio will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
Aybintio is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Aybintio will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Talk to your doctor, pharmacist or nurse before using Aybintio:
Please consult your doctor, even if these above statements were only applicable to you in the past.
Before you are given Aybintio or while you are being treated with Aybintio:
You may be advised to have a dental check-up before you start treatment with Aybintio.
Aybintio 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 Aybintio.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Combinations of Aybintio 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 medicine.
Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer. These therapies in combination with Aybintio may increase the risk of severe side effects.
Please tell your doctor if you have recently received, or are receiving, radiotherapy.
You must not use this medicine if you are pregnant. Aybintio 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 Aybintio and for at least 6 months after the last dose of Aybintio.
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 Aybintio and for at least 6 months after the last dose of Aybintio, as this medicine may interfere with the growth and development of your baby.
Aybintio may impair female fertility. Please consult your doctor for more information. Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Aybintio 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 Aybintio 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.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
The dose of Aybintio 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 Aybintio that is right for you. You will be treated with Aybintio 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 Aybintio fails to stop your tumour growing. Your doctor will discuss this with you.
Do not shake the vial. Aybintio is a concentrate for solution for infusion. Depending on the dose prescribed for you, some or all of the contents of the Aybintio vial will be diluted with sodium chloride solution before use. A doctor or nurse will give you this diluted Aybintio 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.
Stopping your treatment with Aybintio may stop the effect on tumour growth. Do not stop treatment with Aybintio 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.
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 Aybintio was given together with chemotherapy. This does not necessarily mean that these side effects were strictly caused by Aybintio.
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), swelling, lightheadedness, fast heartbeat and loss of consciousness.
You should seek help immediately if you suffer from any of the below mentioned side effects.
Severe side effects, which may be very common (may affect more than 1 in 10 people), include:
Severe side effects, which may be common (may affect up to 1 in 10 people), include:
Severe side effects, which may be rare (may affect up to 1 in 1,000 people), 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 (may affect more than 1 in 10 people) side effects, which were not severe, include:
Common (may affect up to 1 in 10 people) side effects, which were not severe, include:
Patients older than 65 years have an increased risk of experiencing the following side effects :
Aybintio 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.
Aybintio 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 Aybintio is injected directly into the eye (unapproved use), the following side effects may occur:
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.
or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
The unopened vial may be stored at temperatures not exceeding 30°C for up to 35 days. The vial must be discarded if not used within 35 days after removal from refrigerated storage, even if it has been returned to the refrigerator during this period.
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, Aybintio is stable for 45 days at 2°C to 8°C plus an additional 72 hours at temperatures not exceeding 30°C.
Do not use Aybintio 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.
Aybintio 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 Aybintio contains one vial.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 07/2023.