Expanded HCC Clinical Trial Results | OPDIVO® (nivolumab) + YERVOY® (ipilimumab) (2023)

OPDIVO and YERVOY can cause problems that sometimes become serious or life-threatening and can result in death. Serious side effects can include lung problems; bowel problems; liver problems; endocrine gland problems; kidney problems; skin problems; eye problems; problems in other organs and tissues; severe infusion reactions; and complications of stem cell transplantation, including graft-versus-host disease (GVHD) using donor (allogeneic) stem cells. Call or see your doctor right away if there are new or worsening signs or symptoms.

Important facts about OPDIVO®(nivolumab) and OPDIVO + YERVOY®(Ipilimumab)

This is a summary of important information you need to know about OPDIVO and OPDIVO + YERVOY. Your medical team can work with you to help answer your questions about these medications. Keep this information in a safe place so that you can refer to it before and during your treatment.

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OPDIVO is a prescription drug used in combination with YERVOY (OPDIVO + YERVOY) for treatmentLiver cancer (hepatocellular carcinoma). OPDIVO +YERVOY is for adults who:

Have previously been treated with sorafenib.

OPDIVO + YERVOY was approved based on patient response rate and duration of response. The clinical benefit of OPDIVO + YERVOY for this application is continuously evaluated.

It is not known if OPDIVO is safe and effective in children younger than age18 years old

OPDIVO (10mg/ml) and YERVOY(5 mg/ml)are injections for intravenous (IV) use.

What is the most important information I should know about OPDIVO + YERVOY?

OPDIVO and YERVOY are medicines that can treat certain types of cancer 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 how they work. Some of these problems may be more common when OPDIVO is used in combination with another therapy.

Get medical help immediatelyif you develop or worsen any of these signs or symptoms. It can prevent these problems from becoming more serious. Your medical team will check you for these problems during treatment and may treat you with corticosteroids or hormone replacement drugs. If you experience serious side effects, your medical team may also need to delay or stop your treatment altogether.

What are the serious side effects of OPDIVO+YERVOY?

Asevere side effectis a side effect that can sometimes become serious orlife threateningand can lead to death. They can occur at any time during treatment or even after your treatment has stopped. You may have more than one of these problems at the same time.

Call or see your doctor at once if you develop new or worsening signs or symptoms, including:

lung problems —Things to look out for include:

  • new or worsening cough
  • shortness of breath
  • chest pain

intestinal problem –Things to look out for include:

  • diarrhea (loose stools) or more
    frequent bowel movementsas usual
  • black tarry stools,
    are sticky or have blood or mucus
  • severe stomach pain (abdominal pain) or tenderness

liver problems -Things to look out for include:

  • yellowing of your skin or
    the whites of your eyes
  • severe nausea or vomiting
  • Pain on the right side of your
    abdominal area (stomach)
  • dark urine (tea-colored)
  • easy bleeding or bruising
    as normal

endocrine gland problems –Things to look out for include:

  • Headache that won't go away
    or unusual headache
  • Sensitivity of the eyes to light
  • eye problems
  • fast heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • feeling hungrier or thirstier than usual
  • urinate more often than usual
  • hair loss
  • freeze
  • constipation
  • Your voice gets deeper
  • dizziness or fainting
  • Mood or behavior changes such as decreased sex drive, irritability or forgetfulness

kidney problems -Things to look out for include:

  • Decrease in the amount of urine you have passed
  • blood in your urine
  • swelling of your ankles
  • Appetitverlust

skin problems -Things to look out for include:

  • rash
  • itching
  • blistering or peeling of the skin
  • painful sores or sores in your mouth
    or nose, throat or genital area

eye problems -Things to look out for include:

  • blurred vision, double vision or
    other vision problems
  • Eye pain or redness

Problems can also arise in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can occur with OPDIVO and YERVOY. Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

  • Chest pain, irregular heartbeat, shortness of breath, ankle swelling
  • Confusion, sleepiness, memory problems, mood or behavior changes, stiff neck, balance problems, tingling or numbness in your arms or legs
  • Double vision, blurred vision, sensitivity to light, eye pain, blurred vision
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruises

What side effects can OPDIVO + YERVOY have?

OPDIVO + YERVOY can cause serious side effects, including:

See previous section,"What is the most important information I should know about OPDIVO + YERVOY?"

Severe infusion reactions —Things to look out for include:

  • chills or tremors
  • itching or rash
  • rinse
  • shortness of breath or wheezing
  • dizziness
  • feel powerless
  • Fever
  • back or neck pain

Inform your medical teamimmediately if you get these symptoms during an infusion of OPDIVO or YERVOY.

Complications including graft-versus-host disease (GVHD), a bone marrow transplant (stem cell transplant) that uses donor stem cells (allogeneic).These complications can be serious and lead to death. These complications can occur if you have had a transplant either before or after treatment with OPDIVO or YERVOY. Your doctor will monitor you for these complications.

What are the most common side effects?

The most common side effects of OPDIVO when used in combination with YERVOY include:

  • feel tired
  • Diarrhea
  • rash
  • itching
  • nausea
  • Pain in muscles, bones and joints
  • Fever
  • Cough
  • decreased appetite
  • Vomit
  • abdominal pain (abdominal pain).
  • shortness of breath
  • upper respiratory infections
  • Headache
  • low thyroid hormone levels (hypothyroidism)
  • constipation
  • reduced weight
  • dizziness

These are not all possible side effects.Talk to your health teamor pharmacist for more information. You are encouraged to report prescription drug side effects to the FDA. Financial support1-800-FDA-10881-800-FDA-1088.

What should I discuss with my medical team before receiving OPDIVO or YERVOY?

Tell your doctor 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 had a stem cell transplant or are planning to have a stem cell transplant using donor (allogeneic) stem cells
  • if you have had radiation to your chest in the past and have received other medicines such as OPDIVO
  • if you suffer from a disease that affects your nervous system, such as B. myasthenia gravis orGuillain-BarreSyndrome
  • are pregnant or planning to become pregnant. OPDIVO and YERVOY can harm your unborn baby.
  • are breastfeeding or planning to breastfeed. It is not known whether OPDIVO or YERVOY passes into your breast milk. Do not breast-feed during treatment and e.g5 Funafter your last dose of OPDIVO or YERVOY.

Women who can become pregnant:

Your doctor should perform a pregnancy test before you start treatment with OPDIVO or YERVOY.

  • You should use at least one effective method of contraception during your treatment and for at least one5 Funafter the last dose of OPDIVO or YERVOY. Talk to your doctor about birth control methods you can use during this time.
  • Tell your doctor right away if you become pregnant or think you may be pregnant while being treated with OPDIVO or YERVOY. You or your healthcare provider should get in touchBristol Myers Squibbat1-844-593-7869as soon as you find out you are pregnant.

Tell your doctor about all medicines you are taking, including:

  • prescription drugs
  • over-the-counter medicines
  • Vitamins
  • Herbal supplements

For more information, seeUS Full Prescribing InformationAndMedication Guidefor OPDIVO and
US Full Prescribing InformationAndMedication guidefor YERVOY or speak to your medical team.

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