For adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant
whose cancer has come back
OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma if your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and you used the drug brentuximab vedotin (Adcetris®) before or after your stem cell transplant, or after you 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.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
For adults with previously treated classical
lymphoma including an autologous stem cell transplant
whose cancer has come back or spread
The two studies were designed to look at patients’ overall response rate and duration of response. Overall response rate is the percentage of patients who responded to treatment. These patients saw their tumors either shrink or disappear completely. The duration of response is the measure of how long the response lasts.
OPDIVO will not work for everyone. Individual results may vary.See additional clinical trial
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; and abdominal pain.
ADDITIONAL RESOURCES FOR PATIENTS AND CAREGIVERS
View additional materials you or your loved ones may find helpful, including information on support materials, questions to ask your doctor, and other patient resources.Learn More
SELECT IMPORTANT FACTS ABOUT OPDIVO
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
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OPDIVO is a prescription medicine used to treat 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 drug brentuximab vedotin (Adcetris®) 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.
It is not known if OPDIVO is safe and effective in children younger than
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.
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)
- dark urine (tea colored)
- bleeding or bruising more easily
- 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
- 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:
- skin blistering
- ulcers in the mouth or other
Inflammation of the brain
(encephalitis) — Things to look out for may include:
- tiredness or weakness
- memory problems
- seeing or hearing things that are not really there (hallucinations)
- 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
- difficulty breathing
- 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.
Stem cell transplant complications are possible if you receive donor stem cells (allogeneic stem cell transplant). 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.
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
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.
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,
- 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
- herbal supplements
The most common side effects of OPDIVO when used alone include:
- feeling tired
- pain in muscles, bones, and joints
- itchy skin
- shortness of breath
- decreased appetite
- back pain
- upper respiratory tract
- 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