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Summary of Warnings and Precautions

OPDIVO QvantigTM, OPDIVO®, and YERVOY® (ipilimumab) can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; eye problems; problems in other organs and tissues; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms. OPDIVO is associated with severe infusion reactions. See full ISI for OPDIVO and OPDIVO Qvantig below.

Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

Look out for the following icons as you read:

Talk to your
healthcare team

Call a healthcare
provider right away

Helpful information
to remember

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.

Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may 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. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO and OPDIVO + YERVOY?

A serious side effect is a side effect that can sometimes become severe or life-threatening, and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

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

Lung problems — Things to look out for may include:

  • cough
  • shortness of breath
  • chest pain

Intestinal problems — Things to look out for may include:

  • 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 — Things to look out for may include:

    • 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 — Things to look out for may include:

      • headaches 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

        Kidney problems — Things to look out for may include:

        • decrease in your amount of urine
        • blood in your urine
        • swelling of your ankles
        • loss of appetite

          Skin problems — Things to look out for may include:

          • rash
          • itching
          • skin blistering or peeling
          • swollen lymph nodes
          • painful sores or ulcers in the mouth or nose, throat, or genital area
          • fever or flu-like symptoms

            Eye problems — Things to look out for may include:

            • 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 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 eyesight
              • Persistent or severe muscle pain or weakness, muscle cramps
              • Low red blood cells, bruising

                Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ transplant that you have had.

                What are the possible side effects of OPDIVO + YERVOY?

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

                See the previous section, “What is the most important information I should know about OPDIVO + YERVOY?”

                Severe infusion reactions — Things to look out for may include:

                • chills or shaking
                • itching or rash
                • flushing
                • shortness of breath or wheezing
                • dizziness
                • feel like passing out
                • fever
                • back or neck pain

                Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY.

                Complications, including graft-versus-host disease (GVHD), of bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious 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.

                What are the most common side effects?

                The most common side effects of OPDIVO when used alone include:

                  • feeling tired
                  • rash
                  • pain in muscles, bones, and joints
                  • itching
                  • diarrhea
                  • nausea
                  • weakness
                  • cough
                  • shortness of breath
                  • constipation
                  • decreased appetite
                  • back pain
                  • upper respiratory tract infection
                  • fever
                  • headache
                  • stomach-area (abdominal) pain
                  • vomiting
                  • 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
                  • dizziness

                    The most common side effects of OPDIVO when used in combination with YERVOY and chemotherapy include:

                    • feeling tired
                    • pain in muscles, bones, and joints
                    • nausea
                    • diarrhea
                    • rash
                    • decreased appetite
                    • constipation
                    • itching

                      The most common side effects of OPDIVO when used in combination with chemotherapy include:

                      • nausea
                      • feeling tired
                      • pain in muscles, bones and joints
                      • constipation
                      • decreased appetite
                      • rash
                      • vomiting
                      • numbness, pain, tingling, or burning in your hands and feet

                      The most common side effects of OPDIVO when used in combination with cabozantinib include:

                      • diarrhea
                      • feeling tired or weak
                      • liver problems
                      • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
                      • mouth sores
                      • rash
                      • high blood pressure
                      • low thyroid hormone levels
                      • pain in muscles, bones, and joints
                      • decreased appetite
                      • nausea
                      • change in the sense of taste
                      • stomach-area (abdominal) pain
                      • cough
                      • upper respiratory tract infection

                        The most common side effects of OPDIVO when used in combination with fluoropyrimidine- and platinum-containing chemotherapy include:

                        • nausea
                        • numbness, pain, tingling, or burning in your hands or feet
                        • decreased appetite
                        • feeling tired
                        • constipation
                        • mouth sores
                        • diarrhea
                        • vomiting
                        • stomach-area (abdominal) pain
                        • pain in muscles, bones, and joints

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

                          What should I discuss with my healthcare team before receiving OPDIVO or YERVOY?

                          Tell your healthcare provider about all your medical conditions, including if you:

                          • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
                          • have received an organ transplant, including corneal 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 and for 5 months after your 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 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 medicines
                          • over-the-counter medicines
                          • vitamins
                          • herbal supplements

                          Important Facts About OPDIVO Qvantig™ (nivolumab + hyaluronidase-nvhy)

                          This is a summary of important information that you need to know about OPDIVO Qvantig. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this document in a safe place, so you can refer to it before and during your treatment.

                          Look out for the following icons as you read:

                          Talk to your
                          healthcare team

                          Call a healthcare
                          provider right away

                          Helpful information
                          to remember

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

                          OPDIVO Qvantig is a medicine that may treat certain cancers by working with your immune system. OPDIVO Qvantig 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 Qvantig is used in combination with another therapy.

                          Get medical help immediately if you develop any of these signs or symptoms or they get worse. It may 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. If you have severe side effects, your healthcare team may also need to delay or completely stop your treatment.

                          What are the serious side effects of OPDIVO Qvantig?

                          A serious side effect is a side effect that can sometimes become severe or life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

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

                          Lung problems — Things to look out for may include:

                          • cough
                          • shortness of breath
                          • chest pain

                          Intestinal problems — Things to look out for may include:

                          • 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 — Things to look out for may include:

                            • 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 — Things to look out for may include:

                            • headaches 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

                              Kidney problems — Things to look out for may include:

                              • decrease in your amount of urine
                              • blood in your urine
                              • swelling of your ankles
                              • loss of appetite

                                Skin problems — Things to look out for may include:

                                • rash
                                • itching
                                • skin blistering or peeling
                                • swollen lymph nodes
                                • painful sores or ulcers in the mouth or nose, throat, or genital area
                                • fever and flu-like symptoms

                                  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 Qvantig.

                                  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, 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 eyesight
                                  • Persistent or severe muscle pain or weakness, muscle cramps
                                  • Low red blood cells or bruising

                                    Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ transplant that you have had.

                                    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 serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO Qvantig. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

                                    What are the most common side effects of OPDIVO Qvantig?

                                    The most common side effects of OPDIVO Qvantig when used alone in people with renal cell carcinoma include:

                                    • pain in muscles, bones, and joints
                                    • feeling tired
                                    • itchy skin
                                    • rash
                                    • low thyroid hormone levels
                                    • diarrhea
                                    • cough
                                    • stomach area (abdominal) pain

                                    The most common side effects observed with nivolumab given into the vein (intravenous nivolumab), which may be experienced with OPDIVO Qvantig, are shown below.

                                    The most common side effects of intravenous nivolumab when used alone include:

                                    • feeling tired or weak
                                    • rash
                                    • pain in muscles, bones, and joints
                                    • itchy skin
                                    • diarrhea
                                    • nausea
                                    • weakness
                                    • cough
                                    • shortness of breath
                                    • constipation
                                    • decreased appetite
                                    • back pain
                                    • upper respiratory tract infection
                                    • fever
                                    • headache
                                    • stomach-area (abdominal) pain
                                    • vomiting
                                    • urinary tract infection

                                    The most common side effects of intravenous nivolumab when used in combination with cabozantinib as the first treatment for advanced RCC include:

                                    • diarrhea
                                    • feeling tired
                                    • liver problems. See "What is the most important information I should know about OPDIVO Qvantig?"
                                    • rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
                                    • mouth sores
                                    • rash
                                    • high blood pressure
                                    • low thyroid hormone levels
                                    • pain in muscles, bones, and joints
                                    • decreased appetite
                                    • nausea
                                    • change in sense of taste
                                    • stomach area (abdominal) pain
                                    • cough
                                    • upper respiratory tract infection

                                    The most common side effects of intravenous nivolumab when used in combination with platinum-containing chemotherapy and another chemotherapy medicine before having surgery for NSCLC include:

                                    • nausea
                                    • constipation
                                    • feeling tired
                                    • decreased appetite
                                    • rash

                                    The most common side effects of intravenous nivolumab when used in combination with cisplatin and gemcitabine to treat urothelial cancer include:

                                    • nausea
                                    • feeling tired
                                    • pain in muscles, bones, and joints
                                    • constipation
                                    • decreased appetite
                                    • rash
                                    • vomiting
                                    • numbness, pain, tingling, or burning in your hands or feet

                                    The most common side effects of intravenous nivolumab when used in combination with fluoropyrimidine and platinum-containing chemotherapy to treat esophageal cancer and gastric cancer include:

                                    • nausea
                                    • numbness, pain, tingling, or burning in your hands or feet
                                    • decreased appetite
                                    • feeling tired
                                    • constipation
                                    • mouth sores
                                    • diarrhea
                                    • vomiting
                                    • stomach area (abdominal) pain
                                    • pain in muscles, bones, and joints

                                    These are not all of the possible side effects of OPDIVO Qvantig.

                                    Talk to your healthcare team for more information about side effects. You are encouraged to report side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

                                    What should I discuss with my healthcare team before receiving OPDIVO Qvantig?

                                    Talk to your healthcare team 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, including corneal 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 Qvantig
                                    • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

                                    Talk to your healthcare team about all the medicines you are taking, including:

                                    • prescription medicines
                                    • over-the-counter medicines
                                    • vitamins
                                    • herbal supplements

                                    These are not all the topics you should discuss with your healthcare team.
                                    Talk to your healthcare team about anything you might be unsure of before starting treatment.

                                    What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding? 

                                    Talk to your healthcare team if:

                                    You are pregnant or plan to become pregnant: OPDIVO Qvantig can harm your unborn baby.

                                    If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO Qvantig. 

                                    You should use an effective method of birth control during your treatment and for 5 months after your last dose of OPDIVO Qvantig. Talk to your healthcare provider about birth control methods that you can use during this time.

                                    Call your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO Qvantig.

                                    You are breastfeeding or plan to breastfeed: It is not known if OPDIVO Qvantig passes into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of OPDIVO Qvantig.

                                    How will I receive OPDIVO Qvantig?

                                    OPDIVO Qvantig is given as an injection under the skin by your healthcare provider. An injection under the skin is sometimes called a subcutaneous injection. The injection is usually given in the stomach area (abdomen) or thigh, over about 3-5 minutes.

                                    There are 3 parts to an OPDIVO Qvantig appointment:

                                    Before your injection:

                                    Your healthcare provider will do blood tests to check you for side effects.
                                    Your healthcare provider may delay or stop treatment with OPDIVO Qvantig, if you have severe side effects.

                                    Receiving your injection:

                                    Injection time is 3-5 minutes, though actual time in the clinic may vary.

                                    After your injection:

                                    Your healthcare provider may monitor you for side effects after your injection. 

                                    For a type of kidney cancer called advanced renal cell carcinoma, your healthcare provider may also prescribe you cabozantinib. Take cabozantinib exactly as your healthcare provider tells you.

                                    OPDIVO Qvantig is usually given every 2, 3, or 4 weeks, depending on the dose you are receiving.
                                    Your healthcare provider will decide how many treatments you need.

                                    What should I do if I miss an appointment? 

                                    Call your healthcare provider right away to reschedule your appointment.

                                    For more information, please see the U.S. Full Prescribing Information and Medication Guide for OPDIVO Qvantig. Talk to your healthcare provider for more information about this medication.

                                    Information provided on 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.

                                    1992-US-2600068 02/26

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