Ramucirumab Solution for injection

What is this medicine?

RAMUCIRUMAB (ra mue SIR ue mab) is a monoclonal antibody. It is used to treat stomach cancer, colorectal cancer, or lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding disorders

• blood clots

• heart disease, including heart failure, heart attack, or chest pain (angina)

• high blood pressure

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• protein in your urine

• recent surgery

• stroke

• an unusual or allergic reaction to ramucirumab, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need to to check your blood pressure and have your blood and urine tested while you are taking this medicine.

Your condition will be monitored carefully while you are receiving this medicine.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

This medicine may rarely cause 'gastrointestinal perforation' (holes in the stomach, intestines or colon), a serious side effect requiring surgery to repair.

This medicine should be started at least 28 days following major surgery and the site of the surgery should be totally healed. Check with your doctor before scheduling dental work or surgery while you are receiving this treatment. Talk to your doctor if you have recently had surgery or if you have a wound that has not healed.

Do not become pregnant while taking this medicine or for 3 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, breathing problems, swelling of the face, lips, or tongue

• signs of infection - fever or chills, cough, sore throat

• chest pain or chest tightness

• confusion

• dizziness

• feeling faint or lightheaded, falls

• severe abdominal pain

• severe nausea, vomiting

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• symptoms of a stroke: change in mental awareness, inability to talk or move one side of the body

• trouble walking, dizziness, loss of balance or coordination

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• cold, clammy skin

• constipation

• diarrhea

• headache

• nausea, vomiting

• stomach pain

• unusually slow heartbeat

• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.