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

LIBTAYO is a medicine that may treat a type of skin cancer by working with your immune system. LIBTAYO 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 life threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis)

Signs and symptoms of pneumonitis may include:

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

Intestinal problems (colitis) that can lead to tears or holes in your intestine

Signs and symptoms of colitis may include:

  • diarrhea (loose stools) or more frequent bowel movements than usual
  • stools that are black, tarry, or sticky or that have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness

Liver problems (hepatitis)

Signs and symptoms of hepatitis 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)
  • drowsiness 
  • dark urine (tea colored) 
  • bleeding or bruising more easily than normal 
  • feeling less hungry than usual 

Hormone gland problems (especially the adrenal glands, pituitary, thyroid, and pancreas)

Signs and symptoms that your hormone glands are not working properly may include:

  • headaches that will not go away or unusual headaches
  • rapid heartbeat
  • increased sweating
  • extreme tiredness
  • weight gain or weight loss
  • dizziness or fainting
  • feeling more hungry or thirsty than usual
  • hair loss
  • feeling cold
  • constipation
  • deeper voice
  • very low blood pressure
  • urinating more often than usual
  • nausea or vomiting
  • stomach-area (abdomen) pain
  • changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness 

Kidney problems, including nephritis and kidney failure

Signs of these problems may include:

  • decrease in your amount of urine
  • blood in your urine
  • swelling in your ankles
  • loss of appetite

Skin problems

Signs of these problems may include:

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

Problems in other organs

Signs of these problems may include:

  • headache 
  • tiredness or weakness
  • sleepiness
  • changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation)
  • confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis)
  • swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis)
  • seeing or hearing things that are not there (hallucinations)
  • severe muscle weakness
  • low red blood cells (anemia)
  • bruises on the skin or bleeding
  • changes in eyesight

Rejection of a transplanted organ

Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Infusion (IV) reactions that can sometimes be severe and life threatening

Signs of these problems may include:

  • chills or shaking
  • itching or rash
  • flushing
  • shortness of breath or wheezing
  • dizziness
  • fever
  • feeling of passing out
  • back or neck pain
  • facial swelling

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

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

What are the possible side effects of LIBTAYO?

LIBTAYO can cause serious side effects, including those described above. The most common side effects of LIBTAYO include tiredness, rash, and diarrhea. These are not all the possible side effects of LIBTAYO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1.800.FDA.1088.

Talk with your healthcare team any time you have questions or concerns. Your healthcare team will watch for side effects as well during your treatment with LIBTAYO. They may decide to pause or stop your treatment with LIBTAYO due to side effects.

Always follow your healthcare team’s advice about how and when to take LIBTAYO and how to manage side effects.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I know
before starting LIBTAYO?