This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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Alymsys 25mg/ml concentrate for solution for infusion
Alymsys® 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 Alymsys is and what it is used for
2. What you need to know before you use Alymsys
3. How to use Alymsys
4. Possible side effects
5. How to store Alymsys
6. Contents of the pack and other information
Alymsys 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.
Alymsys is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum. Alymsys will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Alymsys 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.
Alymsys is also used for the treatment of adult patients with advanced non-small cell lung cancer. Alymsys will be administered together with a chemotherapy regimen containing platinum.
Alymsys 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). Alymsys will be administered in combination with erlotinib.
Alymsys 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.
Alymsys 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, Alymsys 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, Alymsys will be administered in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin.
Alymsys is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer. Alymsys 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 Alymsys:
Please consult your doctor, even if these above statements were only applicable to you in the past.
Before you are given Alymsys or while you are being treated with Alymsys:
You may be advised to have a dental check-up before you start treatment with Alymsys.
Alymsys 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 Alymsys is injected directly into the eye (unapproved use), the following side effects may occur:
Alymsys 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.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Combinations of Alymsys 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 Alymsys 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. Alymsys 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 Alymsys and for at least 6 months after the last dose of Alymsys.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You must not breast-feed your baby during treatment with Alymsys and for at least 6 months after the last dose of Alymsys, as this medicine may interfere with the growth and development of your baby.
Alymsys may impair female fertility. Please consult your doctor for more information.
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.
Alymsys 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 Alymsys 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 Alymsys 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 Alymsys that is right for you. You will be treated with Alymsys 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 Alymsys fails to stop your tumour growing. Your doctor will discuss this with you.
Do not shake the vial. Alymsys is a concentrate for solution for infusion. Depending on the dose prescribed for you, some or all of the contents of the Alymsys vial will be diluted with sodium chloride solution before use. A doctor or nurse will give you this diluted Alymsys 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 Alymsys may stop the effect on tumour growth. Do not stop treatment with Alymsys 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.
The side effects listed below were seen when Alymsys was given together with chemotherapy. This does not necessarily mean that these side effects were strictly caused by Alymsys.
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:
Alymsys 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.
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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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, Alymsys is stable for a period of up to 30 days at 2°C to 8°C after dilution and a period of up to 48 hours at temperatures not exceeding 30°C.
Do not use Alymsys 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 protect the environment.
Alymsys is a concentrate for solution for infusion (sterile concentrate). The concentrate is a colourless to yellowish or brownish liquid with opalescence 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 Alymsys 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 August 2023.