For Patients With Metastatic Melanoma

About Metastatic

About Metastatic Melanoma

No one is ever ready to hear that they have metastatic melanoma, or melanoma that’s inoperable. Even if they've had a melanoma diagnosis in the past.

If you or a loved one find you’re still struggling to understand what it all means, it may help to break down the diagnosis by each word. Understanding is your first step in defining the path forward that fits your personal goals.

  • Melanoma is a form of skin cancer. There are different forms of skin cancer, but melanoma is the most serious. Melanoma can spread very quickly to other parts of the body, so it is important to detect and treat melanoma in its early stages
  • Metastatic means that your cancer (in this case, melanoma) has spread. Generally, cancer cells do not remain still or "static" and instead, may travel to other parts of your body—either through your bloodstream or lymph nodes. At some point, these cells can start dividing and form new tumors in new areas. The new tumors can be linked back to the melanoma because they contain similar cells
  • Inoperable is sometimes referred to as "unresectable." Both terms mean that the tumor or tumors can’t be removed by surgery, either because it’s spread to too many places or, based on the location, it’s not safe to operate

How is your Melanoma Stage Determined?

Most cancers, including melanoma, are divided into different groups called stages, based on a system developed by oncologists. There are 5 main stages from 0 to 4. Your oncologist may determine the stage of your melanoma by reviewing one or all of a number of factors including your medical history, a physical exam, blood work, and/or a biopsy.

In addition to numbers, doctors also use a system called a TNM staging system. In this system, each of the letters—T, N, and M—describe a different way to measure the growth of your melanoma. The stage of your melanoma is based on a combination of measurements from all of these categories.

If you are diagnosed with metastatic melanoma that means your cancer has already spread. You may be told that it is unresectable, which means that surgery will not be able to remove it either due to its location, how much it has spread, or because it may not be safe to operate.

Metastatic Melanoma Treatment Options

During the course of your treatment with metastatic melanoma, you may have been treated with:

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OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions.

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.

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What is OPDIVO?

OPDIVO is a prescription medicine used to treat people who have a type of skin cancer called melanoma, and who:

Have melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO is approved for both BRAF+ and BRAF- patients. OPDIVO was approved for BRAF+ metastatic melanoma patients based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

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

OPDIVO is a medicine that may treat certain cancers by working with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way these organs work.

What are the serious side effects of OPDIVO?

A serious side effect is a side effect that can sometimes become
life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended.

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

Lung problems (pneumonitis) — Things to look out for may include:

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

Intestinal problems (colitis) that can lead to tears or holes in your intestine — Things to look out for may include:

  • diarrhea (loose stools) or more
    bowel movements than usual
  • blood in your stools or dark,
    tarry, sticky stools
  • severe stomach area (abdomen)
    pain or tenderness

Liver problems (hepatitis) — 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)
  • drowsiness
  • dark urine (tea colored)
  • bleeding or bruising more easily than normal
  • feeling less hungry than usual
  • decreased energy

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas) — Things to look out for may include:

  • headaches that will not go away
    or unusual headaches
  • extreme tiredness
  • weight gain or weight loss
  • changes in mood or behavior,
    such as decreased sex drive,
    irritability, or forgetfulness
  • hair loss
  • feeling cold
  • constipation
  • voice gets deeper
  • excessive thirst or lots of urine

Kidney problems, including nephritis and kidney failure — 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
  • ulcers in the mouth or other
    mucous membranes

Inflammation of the brain (encephalitis) — Things to look out for may include:

  • headache
  • fever
  • tiredness or weakness
  • confusion
  • memory problems
  • sleepiness
  • seeing or hearing things that are not really there (hallucinations)
  • seizures
  • stiff neck

Problems in other organs — Things to look out for may include:

  • changes in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness
  • chest pain

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

  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness
  • fever
  • feeling like passing out

Talk to your healthcare team right away if you get any of the symptoms of a severe infusion reaction during or after an infusion of OPDIVO.

What should I discuss with my healthcare team about pregnancy and nursing before starting OPDIVO?

Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO.

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 during treatment.

Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment.

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

Talk to your healthcare team about all of 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 lung or breathing problems
  • have liver problems
  • have any other medical conditions

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

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

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
  • shortness of breath
  • constipation
  • decreased appetite
  • back pain
  • upper respiratory tract
  • fever
  • headache
  • abdominal pain

These are not all of the possible side effects of OPDIVO. Talk to your healthcare team for more information. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-10881-800-FDA-1088.

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