Ramucirumab 10 mg/ml solution for infusion
What Ramucirumab is used for:
- Ramucirumab is given in combination with paclitaxel, another anti-cancer medicine,
- for the treatment of advanced stomach cancer in adults whose disease has worsened after treatment with medicines to treat cancer.
- Ramucirumab is used for the treatment of advanced stomach cancer in adults whose disease has worsened after treatment with medicines to treat cancer and for whom treatment of Ramucirumab in combination with paclitaxel is not suitable.
- Ramucirumab is used to treat advanced cancers of the colon or rectum in adults.
- It is given with other medicines called ‘FOLFIRI chemotherapy’, including ‘5-fluorouracil’, ‘folinic acid’, and ‘irinotecan’.
- Ramucirumab 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.
- Ramucirumab 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.
- Ramucirumab 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).
You must not be given Ramucirumab:
- if you are allergic to Ramucirumab or any of the other ingredients of this medicine.
- if there is X-ray evidence that the lung cancer has a cavity or hole in it or if the lung cancer is close to major blood vessels.
- Warnings and precautions
- Talk to your doctor or nurse before you are given Ramucirumab if you:
- have any condition which increases the risk of bleeding.
- have liver cancer and have had previous bleeding from enlarged veins in your food pipe.
- have lung cancer and have had recent bleeding in the lung or you are regularly taking non-steroidal anti-inflammatory medicines, or medicines which affect blood clotting ability.
- have high blood pressure.
- have or have had an aneurysm or a tear in a blood vessel wall.
- are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
- have severe liver disease (‘cirrhosis’) and associated conditions, such as excessive accumulation of fluid in your abdomen (‘ascites’).
- have severe kidney problems. There are limited data available about the use of Ramucirumab in patients with severely impaired kidney function.
Possible Side Effects:
- These include feeling tired or weak, low white blood cell counts, diarrhea, hair loss, nose bleed, inflammation of the lining of the mouth, high blood pressure, reduction in red blood cells which can make the skin pale, swelling of hands, feet and legs due to fluid retention,
- low platelet count, abdominal pain, protein in the urine (abnormal urine test), headache, inflammation of mucous membranes, fever, infusion-related reactions, rash, redness, swelling, numbness/tingling, or pain and/or skin peeling in hands and/or feet, hoarseness, bleeding in your lungs, low blood levels of sodium (hyponatraemia), bleeding gums, confusion and/or disorientation in patients with chronic liver problems, abnormal growth of blood vessels, serious infection (sepsis) and low blood levels of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm.
Other medicines and Ramucirumab:
- Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
How you are given Ramucirumab:
- Dosage and frequency of administration
- The correct amount of Ramucirumab needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
- The recommended dose of Ramucirumab 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 Ramucirumab 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.
- 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.
- This medicine is given by infusion via a drip over a period of approximately 60 minutes.
How to store Ramucirumab:
- 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).
- 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 discoloration.