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

For certain previously untreated adults with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas

OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the stomach (gastric), cancer where the esophagus joins the stomach (gastroesophageal junction), and in people with esophageal adenocarcinoma. OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum when your cancer cannot be removed with surgery or has spread to other parts of the body.

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

In a study of 1,581 previously untreated advanced gastric,
gastroesophageal junction, and esophageal adenocarcinoma patients

789 were given OPDIVO + chemotherapy*

792 were given chemotherapy* alone

Of these, 955 patients had a PD-L1 CPS of ≥5. In this group, 473 patients received OPDIVO in combination with chemotherapy* while 482 patients received chemotherapy* alone.

*Modified FOLFOX-6 (leucovorin, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin).


Clinical Trial Results

More People were alive on OPDIVO + chemotherapy* compared to chemotherapy* alone

Patients with PD-L1 CPS ≥5
(n=955)

PEOPLE ALIVE AT 1 YEAR

57%
on OPDIVO + chemotherapy*

compared to

46%
on chemotherapy* alone

OPDIVO + chemotherapy*

OPDIVO® (nivolumab) plus
            chemotherapy clinical trial results for patients with
            a PD-L1 Biomarker greater than or equal to 5

compared to chemotherapy* alone

Half of the patients who were on OPDIVO + chemotherapy* were alive at 14.4 months compared to half being alive on chemotherapy* alone at 11.1 months


All patients regardless of PD-L1 CPS status
(n=1,581)

PEOPLE ALIVE AT 1 YEAR

55%
on OPDIVO + chemotherapy*

compared to

48%
on chemotherapy* alone

OPDIVO + chemotherapy*

OPDIVO® (nivolumab) plus chemotherapy clinical trial results for patients regardless of PD-L1 Biomarker status

compared to chemotherapy* alone

Half of the patients who were on OPDIVO + chemotherapy* were alive at 13.8 months compared to half being alive on chemotherapy* alone at 11.6 months


For patients with PD-L1 biomarker CPS ≥5, half of the patients on OPDIVO + chemotherapy* went 7.7 months without their cancer spreading, growing, or getting worse compared to half who went without their cancer spreading, growing, or getting worse on chemotherapy* alone at 6.0 months.

OPDIVO + chemotherapy* reduced the risk of cancer spreading, growing, or getting worse by 32% compared to chemotherapy* alone.

*Modified FOLFOX-6 (leucovorin, fluorouracil, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin).

Ask your doctor if OPDIVO + chemotherapy is right for you

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

See additional clinical trial
information

ADDITIONAL RESOURCES FOR PATIENTS AND CAREGIVERS

OPDIVO® (nivolumab) patient and caregiver support materials

View additional materials you or your loved one may find helpful, including information on support materials, questions to ask your doctor, and other patient resources.

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OPDIVO® with You Program

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and educational resources
for anyone
considering or currently taking OPDIVO.

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to sign up.

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Important Facts About OPDIVO® (nivolumab)

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 OPDIVO. 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 to treat people with cancer of the stomach (gastric cancer), cancer where the esophagus joins the stomach (gastroesophageal junction cancer), and in people with cancer of the tube that connects the throat to the stomach (esophageal adenocarcinoma). OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum in people whose cancer:

cannot be removed with surgery OR

has spread to other parts of the body.

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 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 the 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
  • 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 of OPDIVO?

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

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

  • numbness, pain, tingling, or burning in your hands or feet
  • nausea
  • feeling tired
  • diarrhea
  • vomiting
  • decreased appetite
  • stomach-area (abdominal) pain
  • constipation
  • 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?

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 U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team.