Immuno-Oncology Teach™ Kit

This online resource was designed to help you and your doctor follow along with each other during a
telehealth visit. You’ll be able to look at the same information at the same time. It will
help you work together as you discuss how the immune system works, how OPDIVO®,
OPDIVO + YERVOY® and Opdualag™ work, and how to identify and report side effects.

This resource will help you learn:

 

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 OPDIVO?

OPDIVO is a prescription medicine used to treat:

Adults and children 12 years of age and older who have a type of skin cancer called melanoma, and:

  • Whose melanoma has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY).

Adults who have a type of advanced stage lung cancer called non-small cell lung cancer (NSCLC):

OPDIVO + YERVOY is approved as a first treatment for adults:

  • Who have lung cancer that has spread to other parts of
    the body (metastatic), AND
  • Whose tumors are positive for PD-L1 but do not have
    an abnormal EGFR or ALK gene.

OPDIVO + YERVOY in combination with 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine (OPDIVO + YERVOY + chemo) is approved as a first treatment for adults:

  • Who have lung cancer that has spread or grown (metastatic) or comes back (recurrent), AND
  • Whose tumors do not have an abnormal EGFR or ALK gene.

OPDIVO is approved for adults who:

  • Have lung cancer that has spread or grown, AND
  • Have tried chemotherapy that contains platinum, and it did not work or is no longer working, AND
  • If their tumor has an abnormal EGFR or ALK gene, they have also tried an FDA-approved therapy for tumors with these abnormal genes and it did not work or is no longer working.

Adults who have a type of early-stage lung cancer called non-small cell lung cancer (NSCLC).

OPDIVO, in combination with chemotherapy that contains platinum and another chemotherapy medicine, is approved for adults with early-stage NSCLC for use before surgery.

Adults who have a type of cancer called malignant pleural mesothelioma, which affects the lining of the lungs and chest wall:

OPDIVO + YERVOY may be used as a first treatment for malignant pleural mesothelioma that cannot be removed by surgery.

Adults who have kidney cancer (renal cell carcinoma):

OPDIVO + YERVOY is approved for certain adults:

  • Whose kidney cancer has spread (advanced RCC), AND
  • Who have not already had treatment for their advanced RCC.

OPDIVO in combination with cabozantinib is approved for adults:

  • 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.

OPDIVO is approved for adults:

  • Whose kidney cancer (RCC) has spread or grown after treatment with other cancer medicines.

Adults who have a type of blood cancer called classical Hodgkin lymphoma, and who:

  • Have classical Hodgkin lymphoma that has come back or
    spread after a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant), AND
  • Used the medicine brentuximab vedotin before or after the stem cell transplant, OR
  • 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.

Adults who have head and neck cancer called squamous cell carcinoma of the head and neck (SCCHN), and who:

  • Have been treated with chemotherapy that contains platinum, but their head and neck cancer has returned or spread after treatment.

Adults who have cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis (urothelial carcinoma).

OPDIVO is approved for adults who have:

  • Urinary tract cancer that has spread or grown (locally advanced or metastatic), AND
  • Tried chemotherapy that contains platinum, and it did not work or is no longer working, OR
  • Cancer that worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove the cancer.

OPDIVO is approved to help prevent cancer from coming back in adults who:

  • Have cancer of the urinary tract (including the bladder, ureters, or renal pelvis), AND
  • Had surgery to remove the cancer.

Adults and children 12 years of age and older who have colorectal cancer (a type of colon or rectal cancer),
and who:

  • Have colorectal cancer that has spread to other parts of the body (metastatic), AND
  • Have a tumor that is microsatellite
    instability-high (MSI-H) or mismatch repair deficient (dMMR), AND
  • Have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.

OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY). OPDIVO and OPDIVO + YERVOY were approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO and OPDIVO + YERVOY for this use.

Adults who have liver cancer (hepatocellular carcinoma), and who:

  • Have previously received treatment with sorafenib.

OPDIVO is used in combination with YERVOY (OPDIVO + YERVOY). OPDIVO + YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO + YERVOY for this use.

Adults and children 12 years of age and older who have a type of skin cancer called melanoma, and who:

  • Have had surgery to remove it and the lymph nodes that contain cancer, to help prevent melanoma from coming back.

Adults who have cancer of the tube that connects the throat to the stomach (esophageal cancer)

OPDIVO +YERVOY is approved for adults:

  • Whose esophageal cancer is a type called squamous cell carcinoma, AND
  • Cannot be removed with surgery (advanced), OR
  • Has spread to other parts of the body (metastatic), AND

They have not already had treatment for their advanced or metastatic esophageal cancer.

OPDIVO with chemotherapy that contains fluoropyrimidine and platinum is approved for adults:

  • Whose esophageal cancer is a type called squamous cell cancer, AND
  • Cannot be removed with surgery (advanced), OR
  • Has spread to other parts of the body (metastatic), AND

They have not already had treatment for their advanced or metastatic esophageal cancer.

Adults who have cancer of the tube that connects the throat to the stomach (esophageal cancer), and their 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 they have received chemotherapy that contains fluoropyrimidine and platinum

Adults who have cancer of the tube that connects the throat to the stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer), and who:

  • Have been treated with chemoradiation, AND THEN
  • Had surgery to completely remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.

OPDIVO may be used to help prevent the esophageal or gastroesophageal junction cancer from coming back.

Adults who have:

  • Cancer of the stomach (gastric cancer).
  • Cancer where the esophagus joins the stomach (gastroesophageal junction cancer).
  • Esophageal adenocarcinoma.

OPDIVO may be used with chemotherapy that contains fluoropyrimidine and platinum in adults whose gastric, gastroesophageal junction, or esophageal 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 melanoma or MSI-H or dMMR metastatic colorectal cancer.

It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.

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 eyesight
  • 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)
  • 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
  • constipation
  • feeling tired
  • decreased appetite
  • rash

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
  • 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

For more information, please see U.S. Full Prescribing Information and Medication Guide for YERVOY.


For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.


Talk to your healthcare team for more information about these medications.


 

Important Facts About Opdualag™ (nivolumab and relatlimab-rmbw)

This is a summary of important information that you need to know about Opdualag. Your healthcare team can work with you to help answer any questions you may have about this medication. 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 Opdualag?

Opdualag is a premixed combination of nivolumab and relatlimab that is prepared and given through intravenous (IV) infusions. Opdualag is a prescription medicine used to treat:

  • Adults who have a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
  • Children who are 12 years of age and older, who have melanoma that has spread or cannot be removed by surgery (advanced melanoma).

It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or in children 12 years and older weighing less than 88 pounds (40 kg) or for the treatment of any other cancers.

An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.

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

Opdualag can cause serious side effects any time during and after treatment. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. Serious side effects may happen anytime during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.

Get medical help right away if you develop any new symptoms or if they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment, and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may need to delay or completely stop your treatment.

Immune system-related side effects

Opdualag is a medicine that may treat melanoma that has spread or cannot be removed by surgery by working with your immune system. Opdualag 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 can sometimes become severe and can lead to death.

This is a list of some possible immune system-related side effects of Opdualag. You may experience other side effects that are not listed. You may experience side effects anytime during treatment or even after treatment has ended.

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:

  • 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 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, nose, throat or genital area

Heart problems — Things to look out for may include:

  • new or worse chest pain
  • irregular heartbeat or feel like your heart is racing
  • shortness of breath
  • tiredness
  • swelling in your ankles

Immune system-related side effects can also happen in other organs and tissues with Opdualag™ (nivolumab and relatlimab-rmbw), including:

Brain and nerve problems — Things to look out for may include:

  • confusion
  • sleepiness
  • memory problems
  • changes in mood or behavior
  • stiff neck
  • balance problems
  • tingling or numbness of the arms or legs

Eye or vision problems — Things to look out for may include:

  • double vision
  • blurry vision
  • sensitivity to light
  • eye pain
  • changes in eyesight

Muscle problems — Things to look out for may include:

  • persistent or severe muscle pain or weakness
  • muscle cramps

Blood problems — Things to look out for may include:

  • low red blood cells
  • bruising

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

What are some other serious side effects of Opdualag?

Severe Infusion Reactions

Opdualag™ (nivolumab and relatlimab-rmbw) is given through intravenous (IV) infusions. The medicine is put directly into your bloodstream through a needle that a healthcare professional places in a vein, usually in your arm or hand.

Things to look out for during an infusion of Opdualag may include:

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

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

Stem Cell Transplant Complications

You may experience complications if you receive donor stem cells (allogeneic stem cell transplant) before or after treatment with Opdualag. These complications can be severe and can lead to death. Your healthcare team will monitor you for signs of complications if you have an allogeneic stem cell transplant.

What are the most common side effects?

The most common side effects of Opdualag include:

  • muscle and bone pain
  • tiredness
  • decreased red blood cell and white blood cell counts
  • increased liver function test results
  • rash
  • itching
  • diarrhea
  • decreased salt (sodium) in your blood

These are not all the possible side effects.

Talk to your healthcare team for more information. 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 about pregnancy, birth control, and breastfeeding?

Talk to your healthcare team if:

  • You are pregnant or plan to become pregnant – Opdualag can harm your unborn baby

    If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving Opdualag. You should use an effective method of birth control during treatment and for at least 5 months after your last dose of Opdualag.

    • Talk to your healthcare team about birth control methods that you can use during this time.
    • Tell your healthcare team right away if you become pregnant or think you are pregnant during treatment with Opdualag.
  • You are breastfeeding or plan to breastfeed

    It is not known if Opdualag passes into your breast milk. Do not breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag.

What should I discuss with my healthcare team before starting treatment?

Talk to your healthcare team about all your health problems or concerns, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have had an organ transplant
  • have had or plan to have a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

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

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

These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.

How will I receive Opdualag?

Opdualag is a premixed prescription medication (12 mg/mL nivolumab and 4 mg/mL relatlimab) that is prepared and given as intravenous (IV) infusions by your healthcare team.

An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.

Dosage:

  • Talk to your healthcare team to learn more about the dosing for Opdualag.

Receiving Opdualag:

  • IV infusion time is about 30 minutes, though actual time in clinic or place of infusion may vary.
  • Opdualag is usually given every 4 weeks. Your healthcare provider will decide how many treatments you will receive and do blood tests to monitor your health and check for side effects.
  • Call your healthcare team as soon as possible to reschedule if you miss any of your appointments.

For more information, please see U.S. Full Prescribing Information and Medication Guide for Opdualag.

Talk to your healthcare team for more information about this medication.