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The product code(s) for this leaflet is: PLGB 14895/0241.
Cyramza 10 mg/ml concentrate for solution for infusion
Cyramza® 10 mg/ml concentrate for solution for infusion
ramucirumab
1. What Cyramza is and what it is used for
2. What you need to know before you are given Cyramza
3. How you are given Cyramza
4. Possible side effects
5. How to store Cyramza
6. Contents of the pack and other information
Cyramza is a cancer medicine that contains the active substance ramucirumab, which is a monoclonal antibody. This is a specialised protein that can recognise and attach to another protein found on blood vessels called ‘VEGF receptor 2’. This receptor is needed in the development of new blood vessels. To grow, cancer needs new blood vessels to develop. By attaching to ‘VEGF receptor 2’ and blocking it the medicine cuts off the blood supply to the cancer cells.
Cyramza is given in combination with paclitaxel, another anti-cancer medicine, for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer.
Cyramza is used for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer and for whom treatment of Cyramza in combination with paclitaxel is not suitable.
Cyramza is used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults. It is given with other medicines called ‘FOLFIRI chemotherapy’, including ‘5-fluorouracil’, ‘folinic acid’, and ‘irinotecan’.
Cyramza is given in combination with erlotinib, another anti-cancer medicine, as the first therapy for the treatment of adult patients with advanced non-small cell lung cancer when the cancer cells have specific changes (mutations) in the epidermal growth factor receptor gene.
Cyramza is given in combination with docetaxel, another anti-cancer medicine, for the treatment of adult patients with advanced stage of lung cancer whose disease has worsened after treatment with medicines to treat cancer.
Cyramza is used to treat liver cancer that is advanced or cannot be taken out by surgery, in adults who have been previously treated with another anticancer medicine (sorafenib) and who have an elevated level of a particular protein in the blood (alpha fetoprotein).
Talk to your doctor or nurse before you are given Cyramza if you:
Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure) during treatment with Cyramza or anytime thereafter:
Cyramza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.
Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby. You should avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Cyramza. Talk to your doctor about the best contraception for you.
As Cyramza inhibits the development of new blood vessels, it may decrease the likelihood of you becoming pregnant or maintaining a pregnancy. It may also cause damage to your unborn baby. You should not use this medicine during pregnancy. If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
It is not known if the medicine passes into breast milk and could affect a breastfed baby. Therefore, you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Cyramza has no or negligible influence on your ability to drive and use machines. If you experience any symptoms affecting your ability to concentrate and react, do not drive or use machines until the effect goes away.
Each 10 ml vial contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free’.
Each 50 ml vial contains approximately 85 mg sodium (main component of cooking/table salt). This is equivalent to approximately 4% of the recommended maximum daily dietary intake of sodium for an adult.
This cancer treatment will be given to you by a doctor or nurse.
The correct amount of Cyramza needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
The recommended dose of Cyramza for the treatment of gastric cancer, for the treatment of advanced cancer of the colon or rectum and for the treatment of liver cancer is 8 mg per kilogram of your body weight once every 2 weeks.
The recommended dose of Cyramza for the treatment of lung cancer is 10 mg per kilogram of your body weight once every 2 weeks when given in combination with erlotinib or once every 3 weeks when given in combination with docetaxel.
The number of infusions you will receive depends on how you are responding to treatment. Your doctor will discuss this with you.
You may be given another medicine to reduce the risk of an infusion-related reaction before you receive Cyramza. If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
During each infusion, your doctor or nurse will check for side effects.
If you experience an infusion-related reaction during treatment, the time taken to give your infusion will be increased for the rest of that infusion and for all future infusions.
The amount of protein in your urine will be checked regularly during treatment. Depending on the protein level measured, Cyramza may be temporarily discontinued. Once the urine protein level has decreased to a certain level, treatment may be restarted with a lower dose.
Cyramza is a concentrate for solution for infusion (also called “sterile concentrate”). A hospital pharmacist, nurse or doctor will have diluted the contents of the vial with sodium chloride 9 mg/ml (0.9%) solution before use. This medicine is given by infusion via a drip over a period of approximately 60 minutes.
Paclitaxel and docetaxel are also given by a drip into a vein (intravenous infusion) over a period of approximately 60 minutes. If you are receiving Cyramza in combination with either paclitaxel or docetaxel on the same day, Cyramza will be given first.
The amount of paclitaxel or docetaxel needed depends on the surface area of your body. Your doctor or hospital pharmacist will calculate your body surface area by measuring your height and weight and will work out the right dose for you.
The recommended dose of paclitaxel is 80 mg for every square metre (m²) of your body’s surface area once every week for 3 weeks followed by 1 week without treatment.
The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body’s surface area once every 3 weeks. If you are of East Asian origin, you may receive a reduced docetaxel starting dose of 60 mg per every m2 of your body’s surface area once every 3 weeks.
Prior to being given any paclitaxel infusion, you will have blood tests to check that your blood counts are high enough and that your liver is functioning well.
Read the paclitaxel or docetaxel package leaflet for further information.
FOLFIRI chemotherapy is given by intravenous infusion, after the Cyramza infusion has finished. Please read the package leaflets for the other medicines that are part of your treatment, to see if they are suitable for you. If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can't use these medicines.
Please read the erlotinib package leaflet for information on erlotinib and whether it is suitable for you. If you are unsure, ask your doctor, pharmacist or nurse if there are any reasons why you can't use erlotinib.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following serious side effects that have been observed during Cyramza treatment (see also What you need to know before you are given Cyramza):
Common side effects (may affect up to 1 in 10 people):
Rare side effects (may affect up to 1 in 1000 people):
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1000 people):
Not known (frequency cannot be estimated from the available data):
Cyramza may cause changes in laboratory tests. From the side effects listed above, these are: low white blood cell counts; low platelet count in the blood; low blood levels of albumin, potassium or sodium; presence of protein in the urine.
If you get any side effects, talk to your doctor. 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 vial label after 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.
Do not freeze or shake the infusion solution. Do not administer the solution if you notice any particulate matter or discolouration.
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.
The concentrate for solution for infusion (or sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow solution in a glass vial with a rubber stopper.
Cyramza is available in packs of:
Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2023
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