Tremelimumab

The most important thing to know

IMJUDO is a medicine that may treat certain cancers by working with your immune system. IMJUDO in combination with durvalumab 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.

You can have more than one of these problems at the same time. 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 new or worsening signs or symptoms, including: Lung problems. 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 (abdomen) 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 increase 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 of your ankles loss of appetite Skin problems. rash itching skin blistering or peeling painful sores or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Pancreas problems. pain in your upper stomach-area (abdomen) severe nausea or vomiting loss of appetite 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 IMJUDO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeats, shortness of breath or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems tingling, numbness or weakness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight persistent or severe muscle pain or weakness, muscle cramps, joint pain, joint stiffness or swelling low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening.

Signs and symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feel like passing out fever back or neck pain 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 IMJUDO.

Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with IMJUDO, if you have severe side effects. What is IMJUDO? IMJUDO is a prescription medicine used to treat adults with: a type of liver cancer called unresectable hepatocellular carcinoma (uHCC).

IMJUDO may be used in combination with durvalumab when your uHCC cannot be removed by surgery. a type of lung cancer called non-small cell lung cancer (NSCLC). IMJUDO may be used in combination with durvalumab and chemotherapy that contains platinum when your NSCLC: o has spread to other part of your body (metastatic), and o your tumor does not have an abnormal “EGFR” or “ALK” gene.

It is not known if IMJUDO is safe and effective in children. Before you receive IMJUDO, tell your

Side effects, and when to stop

IMJUDO can cause serious side effects, including: The most common side effects of IMJUDO when used in combination with durvalumab in adults with uHCC include: rash diarrhea feeling tired itchiness muscle or bone pain stomach area (abdominal) pain The most common side effects of IMJUDO when used in combination with durvalumab and platinum-containing chemotherapy in adults with metastatic NSCLC include: nausea feeling tired or weak muscle or bone pain decreased appetite rash diarrhea Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of IMJUDO. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.