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

OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) after you have received treatment with Nexavar® (sorafenib). 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.

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

OPDIVO is not approved for patients
younger than 18 years of age.

For people with liver cancer
(hepatocellular carcinoma) previously
treated with Nexavar® (sorafenib)

Discover a Different Choice With OPDIVO

How People Responded To OPDIVO in a Clinical Trial


About the Clinical Trial

This OPDIVO study included 154 people with HCC whose cancer spread or grew after treatment with Nexavar® or who could not tolerate Nexavar® therapy.

The study was designed to look at overall response rate (ORR) and duration of response (DoR).

ORR is the percentage of people who responded to treatment. These people saw their tumors either shrink (partial response) or disappear completely (complete response).

DoR is the measure of how long the response lasts.

Clinical Trial Results

14.3%

(22 of 154) people
responded to OPDIVO

12.3% (19 of 154)
saw their tumors shrink (partial response)

1.9% (3 of 154)
saw their tumors disappear completely (complete response)

How Long Did People Respond To OPDIVO in the Clinical Trial?


Half the people whose tumors shrunk or disappeared continued to benefit from OPDIVO for at least 16.6 months

Of those who responded, 50% of people (11 of 22) were still responding to treatment when the data were collected. This clinical trial is still ongoing.

The shortest response lasted
3.2 months

The longest response lasted
38.2 months


91% of people
(20 of 22) had a response
for 6 months or longer

55% of people
(12 of 22) had a response
for 12 months or longer

OPDIVO will not work for everyone. Individual results may vary.


SELECT IMPORTANT FACTS


What are the serious side effects of 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
  • severe infusion reactions

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
  • abdominal pain

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; 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; and abdominal 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 people who have liver cancer (hepatocellular carcinoma), and who:

Have received treatment with Nexavar® (sorafenib).

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.

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.

OPDIVO (10 mg/mL) is an injection for intravenous (IV) use.


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 also 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
  • dizziness or fainting
  • 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 the medicines you take, 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
  • vomiting
  • shortness of breath
  • constipation
  • decreased appetite
  • back pain
  • upper respiratory tract
    infection
  • 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 www.fda.gov/medwatch or call 1-800-FDA-1088.

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