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.
Important Safety Information about YERVOY® (ipilimumab)
YERVOY® (ipilimumab) can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes.
These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with YERVOY. Your oncologist may decide to delay or stop YERVOY.
Call your healthcare provider if you have any signs or symptoms or they get worse. 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:
- 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
- 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
- Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:
- skin rash with or without itching
- sores in your mouth
- your skin blisters and/or peels
- 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
- 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
- Inflammation of the eyes. Symptoms may include:
- blurry vision, double vision, or other vision problems
- eye pain or redness
Pregnancy and Nursing:
- Tell your healthcare provider if you are pregnant or plan to become pregnant. YERVOY may cause stillbirth, premature delivery, and/or death of your unborn baby. Before starting YERVOY, tell your healthcare provider if you are breast-feeding. It is advised that nursing mothers do not breast feed while taking YERVOY.
Tell your healthcare provider about:
- Your health problems if you:
- have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn's disease, lupus, or sarcoidosis
- had an organ transplant, such as a kidney transplant
- have liver damage from diseases or drugs
- have any other medical conditions
- All the medicines you take including:
- all prescription and non-prescription medicines
- steroids or other medicines that lower your immune response
- herbal supplements
You should not start a new medicine before you talk with your healthcare provider who prescribes you YERVOY.
Most Common Side Effects:
The most common side effects of YERVOY include: tiredness, diarrhea, itching, and rash.
These are not all of the possible side effects of YERVOY. If you have any questions about your health or medicines, talk to 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.