OPDIVO^® and OPDIVO + YERVOY^®
are approved for advanced melanoma regardless of BRAFbiomarker status

Important Safety Information for
OPDIVO^® (nivolumab)
and OPDIVO + YERVOY^® (ipilimumab)

What is the most important information I should know about OPDIVO + YERVOY?

OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

• •Lung problems: new or worsening cough; shortness of breath; chest pain
• •Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (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
• •Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heart beat; 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
• •Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
• •Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area
• •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 OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• •Chest pain; irregular heartbeat; shortness of breath; 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 help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.

Possible side effects of OPDIVO + YERVOY
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

• •See “What is the most important information I should know about OPDIVO + YERVOY?”
• •Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or 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), of 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 OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.

The most common side effects of OPDIVO, when used alone, include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; stomach-area (abdominal) pain; and urinary tract infection.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

Before receiving OPDIVO or YERVOY, tell your healthcare provider about all of your medical conditions, including if you:

• •have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• •have received an organ transplant
• •have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• •have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
• •have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• •are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby.
• •are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment with OPDIVO or YERVOY and for 5 months after the last dose of OPDIVO or YERVOY.

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.

• •You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of OPDIVO or 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 OPDIVO or 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 OPDIVO.

Please see U.S. Full Prescribing Information and Medication Guide for YERVOY.

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