Important Safety Information and Indication

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

Opdualag is a medicine that may treat a type of skin cancer called melanoma 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. These problems can sometimes become severe or can lead to death. These problems 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: new or worsening cough; shortness of breath; chest pain
  • Intestinal problems: 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: 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: 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: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
  • Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area
  • Heart Problems: new or worse chest pain; irregular heartbeat or feel like your heart is racing; shortness of breath; tiredness; swelling in your ankles

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Opdualag. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

  • 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

Getting medical help right away may help keep these problems from becoming more serious.

Your healthcare team will check you for these problems during treatment with Opdualag. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop your treatment with Opdualag if you have severe side effects.

Possible side effects of Opdualag

Opdualag can cause serious side effects, including:

  • See “What is the most important information I should know about Opdualag?”
  • Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of Opdualag: chills or shaking; itching or rash; flushing; shortness of breath; dizziness; feel like passing out; fever; back or neck pain
  • Complications of 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 Opdualag. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

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 of Opdualag. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before receiving Opdualag, tell your healthcare provider 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 a condition that affects your nervous system, such as myasthenia gravis, or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. Opdualag can harm your unborn baby

Females who are able to become pregnant:

  • your healthcare provider should do a pregnancy test before you start receiving Opdualag
  • you should use an effective method of birth control during and for at least 5 months after the last dose of Opdualag. 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 during treatment with Opdualag
  • 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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

INDICATION

OpdualagTM (nivolumab and relatlimab-rmbw) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called 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 older who weigh less than 88 pounds (40 kg), or in children younger than 12 years of age.

Opdualag (480 mg/160 mg) is an injection for intravenous (IV) use.

Please see U.S. Full Prescribing Information and Medication Guide for Opdualag.

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