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.
Important Facts About
Opdualag™ (nivolumab and relatlimab-rmbw)
Opdualag can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include: lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; heart problems; problems in other organs and tissues; severe infusion reactions; complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms.
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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What is Opdualag?
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.
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.
Lung problems (pneumonitis) — Things to look out for may include:
- new or worsening cough
- shortness of breath
- chest pain
Intestinal problems (colitis) — 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 (hepatitis) — Things to look out for may include:
- yellowing of your skin or the whites of
- severe nausea or vomiting
- pain on the right side of your stomach
- dark urine (tea colored)
- bleeding or bruising more easily than normal
Hormone gland problems (especially the adrenal, pituitary, and thyroid glands, and pancreas) — Things to look out for may include:
- headaches that will not go away or
- 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
- your voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as
decreased sex drive, irritability, or
Kidney problems (nephritis and kidney dysfunction) — 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 (dermatologic) problems — Things to look out for may include:
- 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
- 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 (neurological)
problems — Things to look out for may include:
- memory problems
- changes in mood or behavior
- stiff neck
- balance problems
- tingling or numbness of the arms or legs
Eye or vision (ocular) problems — Things to look out for may include:
- double vision
- blurry vision
- sensitivity to light
- eye pain
- changes in eyesight
Muscle (musculoskeletal) problems — Things to look out for may include:
- persistent or severe muscle pain or weakness
- muscle cramps
Blood (hematologic) problems — Things to look out for may include:
- low red blood cells
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
- shortness of breath
- feel like passing out
- back or neck pain
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
- decreased red blood cell and white blood cell counts
- increased liver function test results
- decreased salt (sodium) in your blood
These are not all the possible side effects.
What should I discuss with my healthcare team about pregnancy, birth control, and breastfeeding?
What should I discuss with my healthcare team before starting treatment?
- 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
- prescription medicines
- over-the-counter medicines
- 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.
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.