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Important Facts About Opdualag® (nivolumab and relatlimab-rmbw)

This is a summary of important information that you need to know about Opdualag. Your healthcare team can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.

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Helpful information to remember

What is Opdualag?

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Opdualag is a premixed combination of nivolumab and relatlimab that is prepared and given through intravenous (IV) infusions. Opdualag is a prescription medicine used to treat:

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Adults who have a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

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Children who are 12 years of age and older, who have melanoma that has spread or cannot be removed by surgery (advanced melanoma).

It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or in children 12 years and older weighing less than 88 pounds (40 kg) or for the treatment of any other cancers.

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An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.

What is the most important information I should know about Opdualag?

Opdualag can cause serious side effects any time during and after treatment. A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. Serious side effects may happen anytime during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.

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Get medical help right away if you develop any new symptoms or if they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment, and may treat you with corticosteroid or hormone replacement medicines. If you have severe side effects, your healthcare team may need to delay or completely stop your treatment.

Immune system-related side effects

Opdualag is a medicine that may treat melanoma that has spread or cannot be removed by surgery by working with your immune system. Opdualag 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 can sometimes become severe and can lead to death.

This is a list of some possible immune system-related side effects of Opdualag. You may experience other side effects that are not listed. You may experience side effects anytime during treatment or even after treatment has ended.

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Call or see your healthcare provider right away if you develop any new or worsening 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 the amount of urine
  • blood in your urine
  • swelling in 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

Heart problems — Things to look out for may include:

  • new or worse chest pain
  • irregular heartbeat or feel like your heart is racing
  • shortness of breath
  • tiredness
  • swelling in your ankles

Immune system-related side effects can also happen in other organs and tissues with Opdualag™ (nivolumab and relatlimab-rmbw), including:

Brain and nerve problems — Things to look out for may include:

  • confusion
  • sleepiness
  • memory problems
  • changes in mood or behavior
  • stiff neck
  • balance problems
  • tingling or numbness of the arms or legs

Eye or vision problems — Things to look out for may include:

  • double vision
  • blurry vision
  • sensitivity to light
  • eye pain
  • changes in eyesight

Muscle problems — Things to look out for may include:

  • persistent or severe muscle pain or weakness
  • muscle cramps

Blood problems — Things to look out for may include:

  • low red blood cells
  • bruising
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Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms.

What are some other serious side effects of Opdualag?

Severe Infusion Reactions

Opdualag™ (nivolumab and relatlimab-rmbw) is given through intravenous (IV) infusions. The medicine is put directly into your bloodstream through a needle that a healthcare professional places in a vein, usually in your arm or hand.

Things to look out for during an infusion of Opdualag may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath
  • dizziness
  • feel like passing out
  • fever
  • back or neck pain
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Tell your healthcare team right away if you get these symptoms during or after an infusion of Opdualag.

Stem Cell Transplant Complications

You may experience complications if you receive donor stem cells (allogeneic stem cell transplant) before or after treatment with Opdualag. 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.

What are the most common side effects?

The most common side effects of Opdualag include:

  • muscle and bone pain
  • tiredness
  • decreased red blood cell and white blood cell counts
  • increased liver function test results
  • rash
  • itching
  • diarrhea
  • decreased salt (sodium) in your blood

These are not all the possible side effects.

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Talk to your healthcare team for more information. You are encouraged to report side effects of prescription drugs to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?

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Talk to your healthcare team if:

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You are pregnant or plan to become pregnant – Opdualag can harm your unborn baby
If you are able to become pregnant, your healthcare team should do a pregnancy test before you start receiving Opdualag. You should use an effective method of birth control during treatment and for at least 5 months after your last dose of Opdualag.

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Talk to your healthcare team about birth control methods that you can use during this time.

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Tell your healthcare team right away if you become pregnant or think you are pregnant during treatment with Opdualag.

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You are breastfeeding or plan to breastfeed
It is not known if Opdualag passes into your breast milk. Do not breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag.

What should I discuss with my healthcare team before starting treatment?

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Talk to your healthcare team about all your health problems or concerns, including if you:

  • have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
  • have had an organ transplant
  • have had or plan to have a stem cell transplant that uses donor stem cells (allogeneic)
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
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Tell your healthcare team about all the medicines you take, including:

  • prescription medicines
  • over-the-counter medicines
  • vitamins
  • herbal supplements
These are not all the topics you should discuss with your healthcare team. Ask your healthcare team about anything you may be unsure about before starting treatment.

How will I receive Opdualag?

Opdualag is a premixed prescription medication (12 mg/mL nivolumab and 4 mg/mL relatlimab) that is prepared and given as intravenous (IV) infusions by your healthcare team.

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An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional – usually in the arm or hand.

Dosage:

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Talk to your healthcare team to learn more about the dosing for Opdualag.

Receiving Opdualag:

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IV infusion time is about 30 minutes, though actual time in clinic or place of infusion may vary.

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Opdualag is usually given every 4 weeks. Your healthcare provider will decide how many treatments you will receive and do blood tests to monitor your health and check for side effects.

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Call your healthcare team as soon as possible to reschedule if you miss any of your appointments.

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For more information, please see U.S. Full Prescribing Information and Medication Guide for Opdualag.
Talk to your healthcare team for more information about this medication.

Information on this website is not a substitute for talking with your healthcare professional.
Your healthcare professional is the best source of information about your disease.

All individuals depicted are models used for illustrative purposes only.

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