Brand Name(s):

• Yervoy®

IMPORTANT WARNING

Ipilimumab injection may cause severe or life-threatening side effects. This includes inflammation of the intestine, which may cause tears in its walls; inflammation of the liver, which may cause severe liver damage; inflammation of the skin, which may cause a serious skin reaction; inflammation of the nerves, which may cause paralysis (loss of ability to move all or part of the body); inflammation of certain glands, which may affect how the glands work; or inflammation of the eyes. You may develop these symptoms during your treatment or during the first few weeks or months after you finish your treatment. If you experience any of the following symptoms, call your doctor immediately: diarrhea or frequent bowel movements; bloody or black, tarry, sticky stools; stomach pain or tenderness; yellowing of the skin or eyes; dark (tea-colored) urine; pain in the upper right part of the stomach; nausea or vomiting; easy bruising or bleeding; skin rash that may or may not be itchy; blistering or peeling skin; sores in the mouth; unusual weakness of the legs, arms, or face; numbness or tingling in the hands or feet; headaches that are unusual or that don't go away; sluggishness; feeling cold all the time; weight gain; decreased sex drive; irritability; forgetfulness; dizziness; changes in mood or behavior; fainting; blurred vision; double vision; other vision problems; or eye pain or redness. Call your doctor even if you feel that the symptoms you are experiencing are mild and do not try to treat your symptoms yourself. You may be able to prevent these side effects from becoming serious or life-threatening if you get treatment right away.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to see if it is safe for you to receive ipilimumab injection and to check your body's response to ipilimumab injection.

WHY is this medicine prescribed?

Ipilimumab injection is used to treat melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body. Ipilimumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

HOW should this medicine be used?

Ipilimumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 90 minutes by a doctor or nurse in a hospital or medical facility. It is usually given once every 3 weeks for up to four doses.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before receiving ipilimumab injection,

• tell your doctor and pharmacist if you are allergic to ipilimumab injection, any other medications, or any of the ingredients in ipilimumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications that suppress your immune system, including oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had an organ transplant and if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition in which sores form on the lining of the large intestine), lupus (a condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys), or sarcoidosis (condition in which clumps of abnormal cells grow in various parts of the body including the lungs, skin, and eyes), or if your liver has been damaged by a medication or an illness.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ipilimumab injection, call your doctor. Ipilimumab injection may cause your baby to be born too early or to die before birth.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about ipilimumab injection.

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.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2011.