The U.S. Food and Drug

Administration has approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

Yervoy Medication Guide

Read this Medication Guide before you start receiving Yervoy (ipilimumab) and before each infusion. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information about Yervoy

Yervoy can cause serious side effects in many parts of your body which can lead to death. These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion.

These side effects may include:

   1. Inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:

          * diarrhea (loose stools) or more bowel movements than usual

          * blood in your stools or dark, tarry, sticky stools

          * stomach pain (abdominal pain) or tenderness

   2. Inflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:

          * yellowing of your skin or the whites of your eyes

          * dark urine (tea colored)

          * nausea or vomiting

          * pain on the right side of your stomach

          * bleeding or bruise more easily than normal

   3. Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and skin symptoms of severe skin reactions may include:

          * skin rash with or without itching

          * sores in your mouth

          * your skin blisters and/or peels

   4. Inflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:

          * unusual weakness of legs, arms, or face

          * numbness or tingling in hands or feet

   5. Inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:

          * persistent or unusual headaches

          * unusual sluggishness, feeling cold all the time, or weight gain

          * changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness

          * dizziness or fainting

   6. Inflammation of the eyes. Symptoms may include:

          * blurry vision, double vision, or other vision problems

          * eye pain or redness

Call your healthcare provider if you have any of these signs or symptoms or they get worse. Do not try to treat symptoms yourself. Getting medical treatment right away may keep the problem from becoming more serious. Your oncologist may decide to delay or stop Yervoy.