Important Facts About OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)
This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.
What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
What are the serious side effects of OPDIVO and OPDIVO + YERVOY?
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:
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 and YERVOY. 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 + YERVOY?
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
See the previous section, “What is the most important information I should know about OPDIVO + YERVOY?”
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
What are the most common side effects?
The most common side effects of OPDIVO when used alone include:
The most common side effects of OPDIVO when used in combination with YERVOY include:
- feeling tired
- diarrhea
- rash
- itching
- nausea
- pain in muscles, bones, and joints
- fever
- cough
- decreased appetite
- vomiting
- stomach-area (abdominal) pain
- shortness of breath
- upper respiratory tract infection
- headache
- low thyroid hormone levels (hypothyroidism)
- constipation
- decreased weight
- dizziness
The most common side effects of OPDIVO when used in combination with YERVOY and chemotherapy include:
- feeling tired
- pain in muscles, bones, and joints
- nausea
- diarrhea
- rash
- decreased appetite
- constipation
- itching
The most common side effects of OPDIVO when used in combination with chemotherapy include:
- nausea
- constipation
- feeling tired
- decreased appetite
- rash
The most common side effects of OPDIVO when used in combination with cabozantinib include:
- diarrhea
- feeling tired or weak
- liver problems
- rash, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet
- mouth sores
- rash
- high blood pressure
- low thyroid hormone levels
- pain in muscles, bones, and joints
- decreased appetite
- nausea
- change in the sense of taste
- stomach-area (abdominal) pain
- cough
- upper respiratory tract infection
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:
- nausea
- numbness, pain, tingling, or burning in your hands or feet
- decreased appetite
- feeling tired
- constipation
- mouth sores
- diarrhea
- vomiting
- stomach-area (abdominal) pain
- pain in muscles, bones, and joints
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 receiving OPDIVO or YERVOY?
