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 occur in any area of your body; however the most common of these are: intestinal problems (colitis); liver problems (hepatitis); skin problems; nerve problems; and hormone gland problems (especially the pituitary, adrenal, and thyroid glands).
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.
These are not all of the possible side effects of YERVOY. Call your doctor for medical advice about side effects. 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; mucus or blood in your stools; dark, tarry, sticky stools; stomach pain (abdominal pain) or tenderness; and you may or may not have a fever.
- 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; bleeding or bruise more easily than normal; and decreased energy.
- Skin problems that can lead to severe skin reaction. 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.
- Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
- Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
- Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
- Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.
- Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of YERVOY: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.
- Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.
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. If you become pregnant or think you are pregnant, tell your healthcare provider right away. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
- Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
- Before you receive YERVOY, tell your healthcare provider if you are breastfeeding 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: prescription and over-the-counter medicines; vitamins; and herbal supplements.
The most common side effects of YERVOY include: feeling tired, diarrhea, nausea, itching, rash, vomiting, headache, weight loss, fever, decreased appetite, and difficulty falling or staying asleep.
These are not all of the possible side effects of YERVOY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.
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 and children
12 years of age and older 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 12 years of age.
YERVOY will not work for every patient. Individual results may vary.
Information provided in this website is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease.
All individuals depicted are models used for illustrative purposes only.
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