Important Safety Information about YERVOY® (ipilimumab)
What is the most important information I should know about YERVOY?
YERVOY® (ipilimumab) can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You may have more than one of these problems at the same time. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
- Intestinal problems: diarrhea (loose stools) or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach pain (abdominal pain) or tenderness
- Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach- area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
- Skin problems: rash; itching; skin blistering or peeling; painful sores in mouth or nose, throat, or genital area
- Hormone gland problems: headache that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
- Lung problems: new or worsening cough; shortness of breath; chest pain
- Kidney problems: decrease in the amount of urine; blood in your urine; swelling in your ankles; loss of appetite
- Eye problems: blurry vision, double vision, or other vision problems; eye pain or redness
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Yervoy. Call or see your healthcare provider right away for any new or worsening signs or symptoms.
- Chest pain; irregular heartbeat; shortness of breath or swelling of ankles
- Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs
- Double vision; blurry vision; sensitivity to light; eye pain; changes in eye sight
- Persistent or severe muscle pain or weakness; muscle cramps
- Low red blood cells; bruising
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with YERVOY if you have severe side effects.
Possible side effects of YERVOY:
YERVOY can cause serious side effects, including:
- See “What is the most important information I should know about YERVOY?"
- Severe infusion-related reactions. Tell your healthcare team right away if you get these symptoms during an infusion of YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain
- Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with YERVOY. Your healthcare provider will monitor you for these complications.
The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; 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
Before you receive YERVOY, tell your healthcare provider about all your medical conditions, including if you:
- have immune system problems such as ulcerative colitis, Crohn’s disease, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to become pregnant. YERVOY can harm your unborn baby.
- 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.
Females who are able to become pregnant:
Your healthcare provider will give you a pregnancy test before you start treatment with YERVOY.
- You should use an effective method of birth control during your treatment and for 3 months after the last dose of YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with YERVOY. You or your healthcare provider should contact Bristol-Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see U.S. Full Prescribing Information 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® (ipilimumab) is a prescription medicine used in adults to help prevent melanoma (a kind of skin cancer) 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.
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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