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: 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.
YERVOY® (ipilimumab) is a prescription medicine used in adults to treat melanoma (a kind of skin cancer). YERVOY may be used when your melanoma has spread or cannot be removed by surgery and to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
It is not known if YERVOY is safe and effective in children less than 18 years of age.