GLOSSARY

A-G

A

Adrenal Gland

—The adrenal glands are 2 triangle-shaped glands located on the top of each kidney, and they produce many of the hormones the body needs to function properly.

Autologous Stem Cell Transplant

—A procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person.

Autoimmune Disease

—An illness that causes the immune system to produce antibodies that attack normal body tissues.

B

BRAF Gene

—A gene that produces a protein called BRAF that sends messages to influence cells and cell growth. In many cancers, this gene is mutated (or changed), which changes the BRAF protein and in turn can promote the growth and spread of cancer cells.

BRAF Negative

—If your tumor has a normal BRAF gene. Also referred to as wild type.

BRAF Positive

—If your tumor has an abnormal BRAF due to a gene mutation called V600E.

C

Cancer

—A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems.

Chemotherapy

—Treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Clinical Trial

—A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical study.

Complete Response

—The disappearance of any detectable evidence of cancer, such as tumors, in response to treatment. This does not necessarily mean the cancer has been cured. Also called complete remission.

Cortico !steroid

—A corticosteroid is a medicine that is similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They are used to reduce inflammation and affect the immune system.

Crohn’s Disease

—Crohn’s is part of a group of diseases called inflammatory bowel disease. It causes inflammation (swelling) of the digestive system. It often affects the lower part of the small intestine called the ileum. The most common symptoms are pain in the abdomen and diarrhea.

D

d !. M !. M !. R

—An abbreviation for deficient mismatch repair. Cells in your body have a mismatch repair (MMR) system, which can fix inconsistencies in their DNA when DNA is being copied within the cell. d !. M !. M !. R means that this system is deficient, or not functioning properly. This can result in tumors with microsatellite instability (MSI-H).

Duration of Response

—The measure of how long a response to treatment lasts.

H-M

H

Head and Neck Cancer

—Many different types of cancer can occur in the head and neck. The most common is squamous cell carcinoma of the head and neck (SCCHN). Most SCCHN begins in the layer of cells that line the moist surfaces inside the head and neck, for example, the mouth—including the tongue, lips, and cheeks—throat, sinuses, and voice box.

Hormone Replacement

—The use of hormones as a therapy to ease the effects of hormone deficiency.

I

Immune System

—The complex system of cells, tissues, organs, and the substances they make that helps the body fight infections and other diseases.

Immunotherapy

—A type of therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer, infection, and other diseases.

Infusion

—The introduction of a solution, such as certain medicines, into a vein.

Intravenous !. also known as (I !. V)

—IV is an abbreviation for intravenous, which means 'within a vein.' Intravenous medications or fluids are administered through a needle or tube directly into the vein.

L

Lupus

—Lupus is an autoimmune disease, which means that your immune system attacks healthy cells and tissues by mistake. This can damage many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels, and brain.

M

Melanoma

—A form of cancer that begins in melanocytes (cells that make the pigment melanin). It may begin in a mole (skin melanoma), but can also begin in other pigmented tissues, such as in the eye or in the intestines.

Metastatic

—Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

M !. S !. I !. -H

—An abbreviation for microsatellite instability-high. Microsatellites are sections of DNA arranged in a certain order within a cell. The order can change when cells make mistakes repairing themselves. A cell is considered M !. S !. I !. -H when many sections are out of order.

N-S

N

Non-Small Cell Lung Cancer !. also known as (N !. S !. C !. L !. C)

—Non-small cell lung cancer is the most common type of lung cancer.

O

Oncologist

—A doctor who specializes in the treatment of cancer and manages a person’s care once they are diagnosed with cancer.

Overall Response Rate

—Also known as the Objective Response Rate (ORR). The percentage of patients who had a positive response to treatment and saw their tumors either shrink (called a partial response) or present no detectable evidence (called a complete response).

P

Pancreas

—The pancreas is an organ behind the stomach that makes and releases enzymes into the intestines to help with digestion and makes and releases hormones that help control blood sugar levels.

Partial Response

—The decrease in the size of a tumor or the amount of cancer in the body in response to treatment. Also called partial remission.

P !. D !. - 1 Inhibitor

—PD-1 is an acronym for programmed death receptor-1. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of “off switch” that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them evade immune attack.

Pituitary Gland

—The pituitary is a small gland that is located on the base of the brain, and it is responsible for regulating the body’s balance of many hormones.

R

Radiation

—Energy released in the form of particle or electromagnetic waves. Radiation can damage cells and is used to diagnose and treat certain cancers.

Renal Cell Carcinoma !. also known as (R !. C !. C)

—RCC is a type of kidney cancer. About 9 out of 10 kidney cancers are renal cell carcinomas. Although RCC usually grows as a single tumor within a kidney, sometimes there are 2 or more tumors in 1 kidney or tumors in both kidneys at the same time.

S

Side Effects

—Also called drug reactions, side effects are unwanted effects or reactions caused by drugs.

T-Z

T

T Cell

—A type of white blood cell in the immune system that protects the body from infection and may help the body fight cancer.

Thyroid Gland

—The thyroid gland is a butterfly-shaped gland that makes the hormones that help the body use energy, stay warm, and keep all the body’s organs working as they should.

Tumor

—An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called a neoplasm.

U

Ulcerative Colitis

—Ulcerative colitis (UC) is a disease that causes inflammation and sores, called ulcers, in the lining of the rectum and colon. It is one of a group of diseases called inflammatory bowel disease.

FULL INDICATIONS

For certain adults with advanced non-small cell lung cancer (NSCLC)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread or grown, or comes back, and your tumor does not have an abnormal EGFR or ALK gene.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

For people with previously treated advanced non-small cell lung cancer

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

For people with advanced melanoma

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

For people with melanoma after it and the affected lymph nodes have been removed by surgery to prevent it from coming back

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.

For certain people with advanced kidney cancer (renal cell carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer (renal cell carcinoma) in certain people when their cancer has spread.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

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.

For people with previously treated advanced kidney cancer (renal cell carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used to treat people with kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.

For people with previously treated squamous cell carcinoma of the head and neck

OPDIVO® (nivolumab) is a prescription medicine used to treat people with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.

For people with liver cancer (hepatocellular carcinoma) that have received treatment with sorafenib

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

For people with previously treated advanced bladder cancer (urothelial carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used to treat people with bladder cancer (urothelial carcinoma) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For people 12 years of age and older whose CRC has spread to other parts of the body (metastatic), has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and is MSI-H or dMMR

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant whose cancer has come back or spread

OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma if your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and you used the drug brentuximab vedotin before or after your stem cell transplant, or if you received at least 3 kinds of treatment including an autologous stem cell transplant. OPDIVO was approved based on response rate. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For people with previously treated advanced esophageal squamous cell cancer

OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.

For adults newly diagnosed with malignant pleural mesothelioma (MPM)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

For people with esophageal or gastroesophageal junction (GEJ) cancer who have been treated with chemoradiation followed by surgery to help prevent it from coming back

OPDIVO® (nivolumab) is a prescription medicine that may be used to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.

For people with advanced gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC)

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 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or in children younger than 18 years of age for the treatment of any other cancers.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

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:

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    healthcare team
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  • 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:

  • 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 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
  • painful sores or ulcers in the mouth or nose, throat, or genital area

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

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 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.


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
  • 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
  • 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)
  • 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 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:

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

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