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.
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What is OPDIVO?
OPDIVO is a prescription medicine used to treat:
People who have cancer of the tube that connects the throat to the stomach (esophageal cancer) and their cancer:
Is a type called squamous cell carcinoma, AND
Cannot be removed with surgery, AND
Has come back or spread to other parts of the body after treatment with chemotherapy that contains fluoropyrimidine and platinum.
People who have cancer of the tube that connects the throat to the stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) and who:
Have been treated with chemoradiation AND THEN
Had surgery to completely remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
OPDIVO may be used to help prevent the esophageal or gastroesophageal junction cancer from coming back.
People who have:
Cancer of the stomach (gastric cancer), OR
Cancer where the esophagus joins the stomach (gastroesophageal junction cancer), OR
Esophageal adenocarcinoma.
OPDIVO may be used with chemotherapy that contains fluoropyrimidine and platinum in people whose gastric, gastroesophageal junction, or esophageal cancer:
Cannot be removed with surgery OR
Has spread to other parts of the body.
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. Some of these problems may happen more often when OPDIVO is used in combination with another therapy.
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
frequent 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 of 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 any of
the 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
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:
- numbness, pain, tingling, or burning in your hands or feet
- nausea
- feeling tired
- diarrhea
- vomiting
- decreased appetite
- stomach-area (abdominal) pain
- constipation
- 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-10881-800-FDA-1088.
What should I discuss with my healthcare team before receiving treatment?
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.
