For questions about BMS medicines during this time, please call 1-800-721-8909.

For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread

OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat people with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread

Encouraging results with OPDIVO + CABOMETYX

HOW PEOPLE RESPONDED TO OPDIVO + CABOMETYX IN A CLINICAL TRIAL


About the Clinical Trial

In the clinical trial of 651 patients, 323 patients were assigned to receive OPDIVO® (nivolumab) plus CABOMETYX® (cabozantinib) and 328 patients were assigned to receive SUTENT® (sunitinib malate), a standard treatment

PATIENTS LIVED 2X LONGER WITHOUT CANCER PROGRESSING*

*Spreading, growing, or getting worse

Half of patients on OPDIVO + CABOMETYX went 16.6 months without cancer growing, spreading, or getting worse.

VS

Half of patients on SUTENT went 8.3 months without cancer growing, spreading, or getting worse.

OPDIVO + CABOMETYX reduced the risk of cancer speading, growing, or getting worse by 49% compared to SUTENT alone.


2X THE NUMBER OF PATIENTS HAD TUMORS SHRINK OR DISAPPEAR


OPDIVO® (nivolumab) plus CABOMETYX® (cabozantinib) complete response, partial response, and overall tumor response compared to SUTENT® (sunitinib malate)

The disappearance of any measurable tumors in response to treatment. This does not necessarily mean the cancer has been cured.


OPDIVO + CABOMETYX reduced the risk of dying by 40% compared to SUTENT.


OPDIVO + CABOMETYX will not work for everyone. Individual results may vary.

SELECT IMPORTANT FACTS


What are the serious side effects of OPDIVO?

OPDIVO 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
  • severe infusion reactions
  • complications of bone marrow (stem cell) transplant that uses donor stem cell (allogeneic)

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. 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

What are the most common side effects of OPDIVO?

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

Important Facts About OPDIVO®

OPDIVO 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; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplant that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms.

Important Facts About OPDIVO® (nivolumab)

This is a summary of important information that you need to know about OPDIVO. 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 OPDIVO?

OPDIVO is a prescription medicine used in combination with cabozantinib for people:

Whose kidney cancer has spread (advanced RCC) AND

Who have not already had treatment for their advanced RCC.

Please read the Patient Information that comes with cabozantinib.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) is an injection for intravenous (IV) use.


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

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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?

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:

  • new or worsening cough
  • shortness of breath
  • chest pain

Intestinal problems — Things to look out for may include:

  • diarrhea (loose stools) or more
    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 the amount of urine
  • blood in your urine
  • swelling in your ankles
  • loss of appetite

Skin problems — Things to look out for may include:

  • rash
  • itching
  • skin blistering or peeling
  • painful sores or ulcers in the mouth or nose, throat, or genital area

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. 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

What are the possible side effects of OPDIVO?

OPDIVO can cause serious side effects, including:

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

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.

Complications 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. 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 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

These are not all of 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?

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
  • 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 can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO and for 5 months after the last dose of OPDIVO.

Females who are able to become pregnant:

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

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

Tell your healthcare provider about all the medicines you take, including:

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

For more information, please see accompanying U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team.