Ramucirumab (By injection)

Cyramza

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine must be given slowly, so the needle will have remain in place for at least 60 minutes.

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for 3 months after your last dose.
• Do not breastfeed during treatment with this medicine and for 2 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease (including cirrhosis), blood clotting problems, high blood pressure, thyroid problems, or a recent heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of bleeding or blood clotting problems
  • High blood pressure
  • Infusion reactions
  • Increased risk of gastrointestinal perforation (hole in stomach or bowels), which could be life-threatening
  • New or worsening liver disease
  • Reversible posterior leukoencephalopathy syndrome (brain disorder)
  • Kidney disease
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may cause slow wound healing. You may need to stop receiving it 28 days before and for at least 28 days after you have surgery.
• Talk with your doctor before receiving this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody, black, or tarry stools, severe stomach pain or cramps
• Change in how much or how often you urinate, cloudy urine
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Confusion, seizure, extreme drowsiness
• Dark urine, pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Lightheadedness, dizziness, fainting
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg (calf)
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Increased eye tearing
• Lack or loss of strength

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088