For People 12 Years of Age and Older Whose dMMR or MSI-H CRC Has Spread to Other Parts of the Body (Metastatic) and Who Have Tried Chemotherapy With a Fluoropyrimidine, Oxaliplatin, and Irinotecan and It Did Not Work or Is No Longer Working Getting an Infusion

Getting an OPDIVO® Infusion

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.

A dosing schedule with a single 30-MINUTE infusion every two weeks

Week 1

Receive 1st infusion. Infusions will continue every 2 weeks

At About Week 9

Receive 1st scan. Continue treatment every 2 weeks as long as it is working and side effects are tolerable
OPDIVO is given through an intravenous (IV) infusion. The medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional–usually in the arm or hand.
The infusion takes 30 minutes, though actual time in the clinic may vary.
OPDIVO infusions are usually given every 2 weeks. Your doctor will decide how many treatments you need. You should stay on treatment unless the cancer grows or you have unacceptable side effects. Your healthcare provider will do blood tests to check you for side effects, and may treat you with corticosteroid or hormone replacement medicines, and delay or completely stop treatment with OPDIVO if you have side effects that are severe. Be sure to talk to your healthcare team about side effects.
Frequent communication with your healthcare team is an important part of treatment. Use your 2-week 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.
If you miss an appointment, call a healthcare provider right away. Try to schedule your appointments for the same day of the week and the same time of day to make them easier to remember. It is important for you to keep all appointments with your healthcare provider.

Before you receive OPDIVO, tell your healthcare provider 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
  • 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 provider about birth control methods that you can use during this time
    • - Tell your healthcare provider right away if you become pregnant during treatment with OPDIVO
  • Are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed 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.

Questions to Ask Your Doctor Brochure

It can be helpful to review a list of questions you may want to ask your doctor. Download Questions to Ask Your Doctor to help answer your questions about whether OPDIVO may be right for you.

See Clinical Trial Results

See how OPDIVO performed in a clinical trial in patients.
See the Results

OPDIVO®  with You Program

Complimentary support, tools, and educational resources
for anyone considering or currently taking OPDIVO. Call 1-855-OPDIVO-1 or click to learn more.

Sign Up Now

What Should I Know About the Potential Side Effects of OPDIVO?

Learn more about the most common and
serious side effects of OPDIVO.

Learn About Side Effects

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 (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. The most common side effects of OPDIVO when used alone include: feeling tired; pain in muscles, bones, and joints; diarrhea; weakness; shortness of breath; decreased appetite; upper respiratory tract infection; headache; rash; itchy skin; nausea; cough; constipation; back pain; fever; and stomach pain.

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 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 mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H); AND

Have tried chemotherapy with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.

OPIDVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

It is not known if OPDIVO is safe and effective in children less than 12 years of age with MSI-H or dMMR metastatic colorectal cancer.

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 can 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 conditons

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 include:

  • feeling tired
  • pain in muscles, bones,
    and joints
  • diarrhea
  • weakness
  • shortness of breath
  • decreased appetite
  • upper respiratory tract infection
  • headache
  • rash
  • itchy skin
  • nausea
  • cough
  • constipation
  • back pain
  • fever
  • stomach 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 www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.


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