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

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.

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

To help prevent a skin cancer called melanoma from coming back after it and the affected lymph nodes have been removed by surgery

The OPDIVO option: Offering a balance between treatment schedules and regular visits with your healthcare team

These are general recommendations about treatment timing and dosing based on a clinical trial. Only your doctor can make specific recommendations about your treatment with OPDIVO.

Here’s a quick look at the treatment schedule—including the flexible option of every 2 weeks or every 4 weeks for up to 1 year.

OPDIVO® (nivolumab) dosing options:240-mg every 2 weeks or 480-mg every 4 weeks. 30- minute infusion time. First scan at about week 12. Continue treatment every 2 or 4 weeks up to 1 year as long as it's working and side effects are tolerable. Consult your doctor.

OPDIVO is given through an intravenous (IV) infusion. The medicine is given directly into the bloodstream through a vein, usually in the arm or hand, by a healthcare professional.

The infusion takes 30 minutes, though actual time in the clinic may vary.

Your doctor will decide how many treatments are right for you. You may be on treatment until the cancer grows or you have unacceptable side effects for up to 1 year.

Frequent communication with your healthcare team is an important part of treatment. Use your appointment to let them know how you're feeling and ask any questions you may have. You may also be able to talk with others going through a similar situation.

Try to schedule your appointments for the same day of the week to make them easier to remember. It is important to keep all appointments with your healthcare team. If you miss one, call your healthcare team as soon as possible to reschedule your appointment.

A member of your healthcare team will do blood tests to check for side effects during your treatment with OPDIVO and may treat you with a corticosteroid or hormone replacement medicines. OPDIVO treatments may also need to be delayed or completely stopped if you have severe side effects. Be sure to talk to your healthcare team about side effects.

It may be helpful to review a list of questions you might want to ask your doctor. Visit our Patient Resources Page for a list of questions you may want to ask your doctor.

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 , 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 and over-the-counter medicines, vitamins, and herbal supplements.

SELECT 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 bone marrow (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 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.

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.

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 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 your 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 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

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 starting 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.