Purpose: Yervoy is an anti-CTLA-4 monoclonal antibody. It is designed to restore and strengthen the immune system by supporting the activation and proliferation of T-cells, a critical component of the immune system. By supporting T-cells, Yervoy helps sustain an active immune response to fight the cancer cells.

How it works:  Yervoy is a human monoclonal antibody designed to block the activity of a molecule called CTLA-4, a protein that normally helps keep the immune system cells, called T cells, in check. When Yervoy blocks CTLA-4, the drug "takes the breaks off the immune system" and allows T cells to activate and proliferate in order to attack the melanoma cells.

Which patients: Yervoy is approved for patients with unresectable Stage III melanoma (melanoma that cannot be completely removed surgically) or Stage IV melanoma.

How it is given: Yervoy is given intravenously, each dose given over a 90-minute period. Yervoy is usually given every 3 weeks for up to 4 doses. It is given in an outpatient clinic, not in a hospital.

Effectiveness: In a large clinical trial, patients who were treated with Yervoy plus dacarbazine showed a significant improvement in overall survival versus those who received dacarbazine alone. Higher estimated survival rates were observed at one year (47.3% vs.. 36.3%), two years (28.5% vs.17.9%), and three years (20.8% vs. 12.2%). Yervoy improved overall median survival by four months.

Side effects: Because Yervoy makes T cells more responsive to many stimuli (not just cancer cells), the drug can cause powerful autoimmune reactions in which the immune system attacks normal cells in the body.  15% of patients reported autoimmune reactions that were classified as severe and some fatalities did occur in the studies of Yervoy.

• Colitis: (inflammation of the colon), occurs in about 30% of patients and is severe in about 10%-15%. This has led on rare occasions, approximately 1%- 2% of the time, to life-threatening complications and even death from perforation of the colon.  Signs and symptoms of colitis are:
  • diarrhea (loose stools) or more bowel movements than usual
  • blood in your stools or dark, tarry, sticky stools
  • stomach pain (abdominal pain) or tenderness

Important: If you develop diarrhea, you should call your doctor immediately. If you cannot reach your doctor go to the nearest emergency room. In 90% of patients, if found early, diarrhea can be controlled within a few days or weeks with oral steroids.

• Hepatitis: An inflammation of the liver that occurs in less than 5%-10% of cases, but can lead to liver failure. Since it rarely has symptoms, it is important that your liver function be tested before you start Yervoy and during treatment, to identify any elevation in liver enzymes. 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 bruising more easily than normal

Important: Before each dose of Yervoy, your blood should be checked for liver function.

• Skin/Toxicity/Rash: Occurs in about 50% of patients. Typically, it is a rash that comes and goes without itch. However, it can present as a more severe skin reaction (toxic epidermolysis necrolysis). Signs and symptoms of a severe skin reaction are:
  • skin rash with or without itching
  • sores in your mouth
  • skin blisters and/or peels

• Inflammation of Hormone Glands: Dysfunction of the pituitary, adrenal, or thyroid glands, which occurs less than 10% of the time. Signs and symptoms that your glands are not working properly 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

Important: The most common way inflammation of the hormone glands is determined is through blood work. Your physician should monitor this at regular intervals. If you have a preexisting thyroid problem before you start this medicine, it's even more important to watch your blood counts and to make your physician aware of this so that this can be safely monitored.

Other Side Effects:

• Inflammation of the Nerves: This can lead to paralysis. Symptoms of nerve problems may include:
  • unusual weakness of legs, arms, or face
  • numbness or tingling in hands or feet

• Inflammation of the Eyes: Symptoms may include:
  • blurry vision, double vision, or other vision problems
  • eye pain or redness

Additional information/resources:

Financial Support: http://www.destinationaccess.com/yervoy/home.aspx

Risk Evaluation and Mitigation Strategy (REMS Program): click here