Cyramza 500 mg/50 ml 1 Vial (Refrigerator)

Ramucirumab 10 mg/mL solution for infusion

What is ramucirumab and what is it used for:

• Ramucirumab is given in combination with paclitaxel, another anticancer medicine, to treat advanced stomach cancer in adults whose disease has worsened after treatment with cancer medicines.


• Ramucirumab is used to treat advanced stomach cancer (or cancer of the junction between the esophagus and the stomach) in adults whose disease has worsened after treatment with cancer medicines and for whom ramucirumab with paclitaxel is not suitable.


• Ramucirumab is used to treat advanced cancers of the colon and rectum (parts of the large intestine) in adults.


• It is given with other drugs called FOLFIRI chemotherapy, including 5-fluorouracil, folinic acid, and irinotecan.


• Ramucirumab is given in combination with erlotinib, another anticancer drug, as the first line treatment to treat 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 anticancer medicine, to treat adult patients with advanced lung cancer whose disease has worsened after treatment with cancer medicines.


• Ramucirumab is used to treat liver cancer that is advanced or that cannot be removed by surgery, in adults who have previously been treated with another anticancer medicine (sorafenib) and who have a high level of a certain protein in their blood.

Ramucirumab should not be given:

• If you are allergic to ramucirumab or any of the other ingredients of this medicine.


• If there is X-ray evidence of a cavity or perforation in the lung cancer or if the lung cancer is close to major blood vessels.

Warnings And Precautions:

Talk to your doctor or nurse before you receive ramucirumab if you:

• You have any condition that increases your risk of bleeding.


• Have liver cancer and previous bleeding from enlarged veins in the food pipe (esophagus) or high blood pressure in the portal vein, which carries blood from the intestines and spleen to the liver.


• have lung cancer, recent lung bleeding (coughing up bright red blood) or you regularly take non-steroidal anti-inflammatory drugs or drugs that affect the ability of blood to clot.


• Hypertension.


• You have or have had an aneurysm, or a tear in the wall of a blood vessel.


• You will have a planned surgery, if you had surgery recently or if wound healing was poor after surgery.


• You have severe liver disease ("cirrhosis") and associated conditions, such as excessive fluid buildup in your stomach.


• You have severe kidney problems.

Possible side effects of ramucirumab:

• These symptoms include feeling tired or weak, low white blood cell count, diarrhea, hair loss, nosebleeds, inflammation of the lining of the mouth, high blood pressure, decreased red blood cells that can make the skin pale, swelling of the hands, feet, and legs due to fluid retention, decreased platelet count, abdominal pain, protein in the urine (abnormal urine test), headache, inflammation of the mucous membranes, fever, infusion-related reactions,


• Skin rash, redness, swelling, numbness/tingling, pain and/or peeling skin of the hands and/or feet, hoarseness, bleeding in the lungs, low levels of sodium in the blood (hyponatremia), bleeding gums, confusion and/or or confusion in patients with chronic liver problems, abnormal growth of blood vessels, dangerous infection (sepsis) and low levels of potassium in the blood (hypokalemia) which may result in muscle weakness, twitching, or an irregular heartbeat.

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 is ramucirumab given to you:

• Your doctor or hospital pharmacist will calculate the correct amount of ramucirumab needed to treat your disease based on your body weight.


• The recommended dose of ramucirumab for stomach cancer, advanced colorectal cancer, and liver cancer is 8 mg per kilogram of body weight every two weeks.


• The recommended dose of ramucirumab for the treatment of lung cancer is 10 mg per kg of body weight, once every 2 weeks when taken with erlotinib, or once every 3 weeks when given with docetaxel.


• The number of injections you will receive depends on how you respond to treatment.


• You may be given another medication to reduce the risk of an infusion-related reaction before you receive ramucirumab.


• If you have an infusion-related reaction during treatment with ramucirumab, you will be given medication in advance of all future injections.


• During each injection, your doctor or nurse will check for side effects.


• If you experience an infusion-related reaction during treatment, the time it takes to give the infusion will be increased for the rest of that infusion and for all future injections.


• The amount of protein in your urine will be checked regularly during treatment.


• Depending on the protein level measured, ramucirumab may be temporarily stopped.


• Once the level of protein in the urine has fallen to a certain level, treatment can be restarted at a lower dose.


• Ramucirumab is a concentrate for infusion solution.


• The hospital pharmacist, nurse, or doctor will dilute the contents of the vial with sodium chloride solution 9 mg/ml (0.9%) before use.


• This medication is given as an infusion via a drip over about 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 carton and outer bottle label.


• The expiration date refers to the last day of the same month.


• Store in the refrigerator (2°C - 8°C).


• The vial is in the outer carton box to protect it from light.


• Do not freeze or shake the infusion solution.


• Do not administer the solution if you notice any particles or discoloration.