Glossary

BRAF gene—A gene that produces a protein that sends messages to influence cells and cell growth. In many cancers, this gene is changed or mutated, which in turn can promote the growth and spread of cancer cells.

BRAF negative—Also referred to as wild type. No change in BRAF gene detected.

BRAF positive—Also called BRAF mutant. A change in the BRAF gene.

cancer—Diseases in which abnormal cells grow out of control, usually in a lump or mass called a tumor. Tumors can destroy healthy tissue, and cancer cells can spread to other parts of the body through the blood and lymph systems.

cell—The basic unit of living tissue in the body. Cells are replaced through a process of division and duplication. This process is disrupted in cancer.

chemotherapy—Also called chemo. Drugs that kill cells that grow rapidly; including both normal and cancer cells.

clinical trial—Also called clinical study. A research program that tests the safety and effectiveness of a new drug or treatment. Can also be used to test new ways of screening for, diagnosing, or preventing a disease.

experimental drug—A substance or agent that, after laboratory testing, has been approved by the FDA for testing in humans.

FDA (Food and Drug Administration)—The U.S. federal agency charged with regulating pharmaceutical drugs, vaccines, and medical devices for their safety, effectiveness, and security.

gene—Pieces of DNA with information the body uses to make new cells and specific proteins; also used to pass traits from parents to offspring.

imaging test—Also called imaging procedure or study. The process of taking pictures of areas or structures inside the body. X-rays, CT scans, magnetic resonance imaging (MRI), PET scans, and ultrasound are all imaging tests that can be used to diagnose or stage cancer.

immune system—The complex system that is the body’s natural defense against infection and disease. It may help the body fight some cancers.

immunotherapy—Treatment that can enhance the ability of the body’s immune system to fight disease.

immuno-oncology—A field of cancer research and treatment involving therapies designed to work with the body’s immune system to fight cancer.

infusion—Also called intravenous infusion or IV. The process of putting medicines and fluids into the bloodstream through a needle inserted in a vein.

lymph node—Also called lymph glands. Small, bean-sized organs that support the immune response. Lymph nodes function to trap threats throughout the body.

malignant—Cancerous; indicates disease where cells growing out of control can invade and destroy nearby tissue, spreading to other parts of the body.

melanoma—Cancer that starts in the cells that give skin its brownish color (melanocytes). If not discovered early enough, or left untreated, melanoma can spread to other parts of the body, making it the most dangerous form of skin cancer. However, it is usually curable if discovered early.

metastatic—A cancer that has spread from where it started to other places in the body.

mutation—Any change in the DNA sequence of a cell. One could inherit a DNA mutation (be born with it), or acquire the mutation (happens after being born).

oncologist—A doctor with special training in the diagnosis and treatment of cancer. Some oncologists specialize in specific cancers.

prognosis—A prediction for the course of a disease; the chance of recovery, recurrence, or survival.

radiation therapy—A therapy that uses high-energy waves to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body or it may come from radioactive material placed in the body near cancer cells.

side effect—An undesired effect of a medical treatment.

systemic therapy—A treatment that goes into the body, travelling through the bloodstream to reach and affect cells all over the body. Systemic therapy could include chemotherapy and immunotherapy.

T cell—A type of white blood cell in the immune system that protects the body from infection and may help the body fight cancer.

tumor—An abnormal lump or mass of tissue (a layer of cells). A tumor forms when cells divide more than they should or do not die when they should. Tumors can be benign (not cancerous) or malignant (cancerous).

unresectable—Not able to be surgically removed.

More Important Safety Information +

Important Safety Information about YERVOY® (ipilimumab)

YERVOY can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines; liver problems (hepatitis) that can lead to liver failure; skin problems that can lead to severe skin reaction; nerve problems that can lead to paralysis; hormone gland problems (especially the pituitary, adrenal, and thyroid glands); and eye problems.

These problems may happen anytime during treatment with YERVOY or after you have completed treatment. Getting medical treatment right away may keep the problem from becoming more serious. Your healthcare provider will check you for these problems during treatment with YERVOY. Your healthcare provider may treat you with corticosteroid medicines. Your healthcare provider should perform blood tests, such as liver, hormone, and thyroid function tests, before starting and during treatment with YERVOY. Your healthcare provider may need to delay or completely stop treatment with YERVOY, if you have severe side effects.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Do not try to treat symptoms yourself.

Serious side effects may include:

  • Intestinal problems (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; and stomach pain (abdominal pain) or tenderness
  • Liver problems (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; and bleeding or bruise more easily than normal
  • Skin problems that can lead to severe skin reactions. Signs and symptoms of severe skin reactions may include: skin rash with or without itching; sores in your mouth; and your skin blisters and/or peels
  • Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet
  • Hormone gland problems (especially the pituitary, adrenal, and thyroid glands). Signs and symptoms that your glands are not working properly may include: persistent or unusual headaches; unusual sluggishness; feeling cold all the time; weight gain; changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness; and dizziness or fainting
  • Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness

Pregnancy and Nursing:

  • Before you receive YERVOY, tell your healthcare provider if you are pregnant or plan to become pregnant. YERVOY can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment with YERVOY and for 3 months after the last dose of YERVOY. Before you receive YERVOY, tell your healthcare provider if you are breast-feeding or plan to breastfeed. It is not known if YERVOY passes into your breast milk. Do not breastfeed during treatment with YERVOY and for 3 months after the last dose of YERVOY.

Tell your healthcare provider about:

  • All your medical conditions, including if you: have immune system problems (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis; have had an organ transplant; and have liver problems
  • All the medicines you take including: all prescription and over-the-counter medicines; vitamins; and herbal supplements

Know the medicines you take. Keep a list to show your healthcare provider and pharmacists each time you get a new medicine. You should not start a new medicine before you talk with the healthcare provider who prescribes you YERVOY.

The most common side effects of YERVOY include: tiredness, diarrhea, itching, rash, nausea, vomiting, headache, weight loss, fever, decreased appetite, and difficulty falling or staying asleep.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of YERVOY. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for YERVOY.

Indication

YERVOY® (ipilimumab) is a prescription medicine used in adults to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable).

It is not known if YERVOY is safe and effective in children less than 18 years of age.