This site is for patients using OPDIVO or OPDIVO and ipilimumab.

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Reporting side effects | Patient resources |

Your guide to OPDIVO and side effects that can occur with treatment

This site is for patients using OPDIVO or OPDIVO and ipilimumab.

Signs and symptoms of your treatment

OPDIVO or OPDIVO in combination with YERVOY can cause serious or even life-threatening side effects.

Signs and symptoms of side effects may happen any time during treatment or even months after your treatment has ended.

What to do if you suspect a side effect:

  • - Call your doctor immediately if you experience signs or symptoms or if they get worse. Signs and symptoms that may appear mild can quickly worsen if left untreated.
  • - DO NOT treat any signs and symptoms yourself.
  • - DO NOT feel embarrassed or worry that you are bothering your doctor.

The following are NOT all the possible signs and symptoms of side effects of OPDIVO treatment. For more information, ask your doctor or pharmacist or read the additional information in Patient resources.

Please note: Some signs and symptoms that are shown occurring in one part of your body may be related to a side effect in another part of your body (for example, yellow skin may represent a liver problem).

Please note: Contact your doctor if you need advice, information, and support.

Signs and symptoms to look out for:

The following are NOT all of the possible signs and symptoms of side effects from treatment with OPDIVO or OPDIVO in combination with YERVOY. For more information, ask your doctor or nurse and/or read the OPDIVO Patient Medication Information leaflet (and also, if relevant, the YERVOY Patient Medication Information leaflet).

General

- Changes in mood or behaviour, such as decreased sex drive, irritability, forgetfulness, or depression

- Confusion and memory problems

- Feeling unwell

- Fever

- Headaches

- Increased or decreased appetite

- Nausea or vomiting

- Seizures (fits)

- Seeing things that are not really there (hallucinations)

- Swelling in extremities

- Swollen lymph nodes

- Excessive thirst

- Hunger

- Sensation of paralysis

- Pain on the right side of your stomach (abdomen)

- Tiredness

- Weight gain or loss

- Tingling and/or numbness (e.g., in your fingers or toes)

- Sleepiness or drowsiness

Eyes

- Changes in eyesight (blurry vision, double vision, or other vision problems)

- Eye pain or redness

- Yellowing of the whites of your eyes

Skin

- Bruising easily

- Dry skin

- Itching

- Raised skin lumps/bumps (skin nodules)

- Severe skin reaction or rash

- Skin blistering/peeling

- Skin yellowing (jaundice)

Muscles and bones

- Difficulty walking

- Numbness in arms and/or legs

- Muscle or joint pains

- Muscle weakness or stiffness

- Stiff neck

Mouth, nose, and throat

- Ulcers in the mouth or other mucous membranes

Chest

- Chest pain

- Breathing difficulties

- Cough (new or worsening)

- Irregular heartbeat, palpitations (being more aware of heartbeat than normal)

Stomach and bowel (gut)

- Dark, tarry, or sticky stools

- Blood or mucous in your stools

- Diarrhea (watery, loose or soft stools) or more bowel movements than usual

- Heartburn or indigestion

- Pain or tenderness in your stomach or abdominal area

Kidneys and bladder

- Decreased or increased amounts of urine

- Darker urine than normal (tea-coloured)

Other important side effects

Severe infusion reaction

• Reactions to infusing OPDIVO or OPDIVO in combination with YERVOY into the bloodstream might occur, usually during or within 24 hours of receiving a dose.

• Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO or OPDIVO in combination with YERVOY: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.

Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO

• Donated stem cells contain T cells that can attack your own body cells if they see them as foreign. These complications can be severe and can lead to death.

• Inform your doctor if you underwent an allogeneic stem cell transplant either before or after being treated with OPDIVO, in order for your doctor to monitor you for signs of complications (e.g., skin rash, liver inflammation, abdominal pain, and diarrhea).

Rejection of a transplanted organ

• People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with OPDIVO.

• Please tell your doctor before treatment if you have had an organ transplantation.

 

If you want to test your knowledge on this section, answer the questions below.

 

Thank You for Testing Your Knowledge

Which of the following statements about OPDIVO are correct? (Select all that apply)

  • Signs and/or symptoms can occur at any time during treatment or even after treatment has ended
  • If signs and/or symptoms are mild there is no need to consult with a doctor
  • It is important not to attempt to treat your symptoms yourself
  • It is NOT necessary to always carry the Patient Alert Card with you
  • I don’t know
OPDIVO has the potential to cause serious side effects. Signs and/or symptoms of side effects can occur at any time during your treatment or even up to months after your treatment has ended. Always carry the Patient Alert Card with you. Call your doctor immediately if you experience signs and/or symptoms or if they get worse. Signs and/or symptoms that may appear mild can quickly worsen if left untreated.

Why is it important to contact your treatment centre if you believe you may have signs and/or symptoms of a side effect? (Select all that apply)

  • Signs and/or symptoms need to be treated immediately
  • Signs and/or symptoms may worsen if left untreated
  • Treatment may need to be stopped temporarily
  • Treatment may need to be stopped permanently
  • You should not attempt to treat signs and/or symptoms yourself
  • It isn’t necessary, as I can manage signs and/or symptoms myself
OPDIVO can cause serious side effects that need to be treated as early as possible, since they may worsen if left untreated. If side effects are not treated, treatment may need to be suspended or stopped. It is very important that patients should not attempt to treat signs and/or symptoms of possible side effects; therefore, it is important to seek medical assistance immediately if you suspect signs and/or symptoms of side effects, no matter how mild.

When can the side effects of OPDIVO treatment occur? Only one option is correct.

  • Only during the first OPDIVO treatment
  • Only within the first 12 weeks of treatment
  • At any point during the treatment or up to months after treatment
  • Only after the last dose
  • I don’t know
Side effects can occur at any time during your treatment or even up to months after your treatment has ended. If you experience any unusual signs or symptoms, you should seek medical assistance immediately. You should not attempt to treat these signs and/or symptoms yourself.

What should you do if you believe you may be experiencing signs and/or symptoms while, or up to 5 months after, you are taking OPDIVO? (Select all that apply)

  • Seek medical help immediately
  • Call your doctor immediately
  • Try to treat the signs and/or symptoms yourself
  • Tell your doctor at your next routine appointment
  • Show your Patient Alert Card to doctors/nurses who assist you
  • I don’t know
If you believe that you are experiencing signs and/or symptoms of side effects during or after treatment with OPDIVO, you should seek immediate medical assistance, for example, by telling your doctor. Under no circumstances should you attempt to treat signs and/or symptoms yourself. Always carry your Patient Alert Card with you and show it to any doctor you see (for example, if your regular doctor is unavailable or you are travelling).

What should you do if signs and/or symptoms you experience while you are on treatment get worse? (Select all that apply)

  • Seek medical help immediately
  • Call your doctor immediately
  • Try to treat the symptoms yourself
  • Tell your doctor at your next routine appointment
  • Show your Patient Alert Card to doctors/nurses who are with you
  • I don’t know
If you believe that signs and/or symptoms you are being treated for are getting worse, you should seek immediate medical assistance, for example, by telling your doctor. Under no circumstances should you attempt to treat signs and/or symptoms yourself. Always carry your Patient Alert Card with you and show it to any doctor you see (for example, if your regular doctor is unavailable or you are travelling).

Tiredness, headaches and nausea are symptoms that can occur during or even after treatment has ended. Which of the following statements about OPDIVO are correct? (Select all that apply)

  • If signs and/or symptoms are mild there is no need to consult with a doctor
  • It is possible to take pain-killers and wait to see if the symptoms get better
  • It is important not to attempt to treat signs and/or symptoms yourself
  • It is okay to wait and see if symptoms get better on their own
  • Call your doctor immediately
  • I don’t know
OPDIVO has the potential to cause serious side effects. Signs and/or symptoms of side effects can occur at any time during your treatment or even up to months after your treatment has ended. Call your doctor immediately if you experience signs and/or symptoms or if they get worse and do not attempt to treat any signs and/or symptoms yourself. Signs and/or symptoms that may appear mild can quickly worsen if left untreated.

Diarrhea (watery, lose or soft stools) and pain in the stomach area/abdomen are signs and symptoms that can occur during or even after treatment has ended. Which of the following is true? (Select all that apply)

  • It is important that signs and symptoms such as these are treated immediately
  • Signs and symptoms such as these may worsen if untreated
  • It is important not to attempt to treat signs and symptoms yourself
  • It is possible to take over-the-counter medication without consulting a doctor if signs and symptoms are mild
  • I don’t know
OPDIVO can cause serious side effects that need to be treated immediately, because they may worsen if left untreated. It is important that patients should not attempt to treat signs and/or symptoms themselves; therefore, it is important to seek medical assistance immediately if you suspect signs and/or symptoms of side effects, no matter how mild. If signs and/or symptoms of side effects are not promptly and properly treated, treatment may need to be suspended or stopped.

Yellowish skin discoloration, yellowing of the whites of your eyes, itchy skin and tingling/numbness are signs and symptoms that can occur during or even after treatment has ended. What should you do if you believe you might be experiencing any of those signs and/or symptoms? (Select all that apply)

  • Seek medical help immediately
  • Wait to see if your signs and/or symptoms get better on their own
  • Call your doctor immediately
  • Show your Patient Alert Card to any doctors/nurses who you see
  • I don’t know
If you believe that you are experiencing signs and/or symptoms of side effects during or after treatment with OPDIVO, you should seek immediate medical assistance, for example, by immediately telling your doctor. Under no circumstances should you attempt to treat signs and/or symptoms yourself. Always carry your Patient Alert Card with you and show it to any doctor you see (for example, if your regular doctor is unavailable or you are travelling).

Indigestion and heartburn are symptoms that can occur during or even after treatment has ended. What should you do if you believe you might be experiencing any of those symptoms? (Select all that apply)

  • Tell your doctor at your next routine appointment
  • Seek medical help immediately
  • Show your Patient Alert Card to any doctors/nurses you see
  • Some over-the-counter medications may relieve the symptoms until the next appointment with your doctor.
  • I don’t know
If you believe that you are experiencing signs and/or symptoms of side effects during or after treatment with OPDIVO, you should seek immediate medical assistance. Under no circumstances should you attempt to treat signs and/or symptoms yourself. Always carry your Patient Alert Card with you and show it to any doctor you see.

Weakness, difficulty walking and/or leg stiffness are signs and symptoms that can occur during or even after treatment has ended. Which of the following statements about OPDIVO are correct? (Select all that apply)

  • If signs and symptoms are mild there is no need to see a doctor
  • Painkillers may alleviate signs and/or symptoms until your next appointment.
  • It is important not to attempt to treat signs and/or symptoms yourself
  • If signs and/or symptoms are mild, it is okay to wait and see if they get better on their own
  • Call your doctor immediately
  • I don’t know
OPDIVO has the potential to cause serious side effects. Signs and/or symptoms of side effects can occur at any time during your treatment or even up to months after your treatment has ended. Call your doctor immediately if you experience signs and/or symptoms or if they get worse, and do not attempt to treat any signs and/or symptoms yourself. Signs and/or symptoms that may appear mild can quickly worsen if left untreated.
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