Ramucirumab Injection

Ramucirumab injection is used alone and in combination with another chemotherapy medication to treat stomach cancer or cancer located in the area where the stomach meets the esophagus (the tube between the throat and stomach) when these conditions do not improve after treatment with other medications. Ramucirumab is also used in combination with docetaxel to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to other parts of the body in people who have already been treated with other chemotherapy medications and have not improved or worsened. It is also used in combination with erlotinib (Tarceva) to a certain type of NSCLC that has spread to other parts of the body. Ramucirumab is also used in combination with other chemotherapy medications to treat cancer of the colon (large intestine) or rectum that has spread to other parts of the body in people that have already been treated with other chemotherapy medications and have not improved or worsened. Ramucirumab is also used alone to treat certain people with hepatocellular carcinoma (HCC; a type of liver cancer) who have already been treated with sorafenib (Nexafar). Ramucirumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.

Ramucirumab injection comes as a liquid to be injected into a vein over 30 or 60 minutes by a doctor or nurse in a hospital or medical facility. For the treatment of stomach cancer, cancer of the colon or rectum, or HCC, it is usually given once every 2 weeks. For the treatment of NSCLC along with erlotinib, ramucirumab is usually given once every 2 weeks. For the treatment of NSCLC along with docetaxel, ramucirumab is usually given once every 3 weeks. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Your doctor may need to interrupt or stop your treatment if you experience certain side effects. Your doctor will give you other medications to prevent or treat certain side effects before you receive each dose of ramucirumab injection. Tell your doctor or nurse if you experience any of the following while you receive ramucirumab: uncontrollable shaking of a part of the body; back pain or spasms; chest pain and tightness; chills; flushing; shortness of breath; wheezing; pain, burning, numbness, pricking, or tingling in the hands or feet or on the skin; breathing difficulties; or a fast heartbeat.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving ramucirumab injection,

• tell your doctor and pharmacist if you are allergic to ramucirumab or any other medications or any of the ingredients in ramucirumab injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had high blood pressure, or thyroid or liver disease. Also tell your doctor if you have a wound that has not healed yet, or if you develop a wound during treatment that is not healing properly.
• you should know that ramucirumab may cause infertility in women (difficulty becoming pregnant); however, you should not assume that you cannot get pregnant. Tell your doctor if you are pregnant or plan to become pregnant. You should have a pregnancy test before you start treatment. You should use birth control to prevent pregnancy during your treatment and for at least 3 months after your final treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant during your treatment with ramucirumab injection, call your doctor immediately. Ramucirumab may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with ramucirumab and for 2 months after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving ramucirumab injection. Your doctor may tell you not to receive ramucirumab injection during the 28 days before your surgery. You may only be allowed to restart treatment with ramucirumab injection if it is at least 14 days after your surgery and the wound is healed.

Unless your doctor tells you otherwise, continue your normal diet.

Call your doctor right away if you are unable to keep an appointment to receive a dose of ramucirumab injection.

Ramucirumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• sores in the mouth or throat

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash
• sudden weakness of an arm or leg
• drooping of one side of the face
• difficulty speaking or understanding
• crushing chest or shoulder pain
• slow or difficult speech
• chest pain
• shortness of breath
• headache
• dizziness or faintness
• seizures
• confusion
• change in vision or loss of vision
• extreme tiredness
• swelling of the face, eyes, stomach, hands, feet, ankles, or lower legs
• unexplained weight gain
• foamy urine
• sore throat, fever, chills, ongoing cough and congestion, or other signs of infection
• coughing up or vomiting blood or material that looks like coffee grounds, unusual bleeding or bruising, pink, red, or dark brown urine, red or tarry black bowel movements, or lightheadedness
• diarrhea, vomiting, abdominal pain, fever, or chills

Ramucirumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. For some conditions, your doctor may order a lab test before you begin your treatment to see whether your cancer can be treated with ramucirumab. Your doctor our doctor will check your blood pressure and test your urine regularly during your treatment with ramucirumab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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