Tremelimumab is used in adults to treat a certain type of liver cancer and lung cancer.

Tremelimumab may be used in combination with other cancer treatments when the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery.

Your doctor will make sure you have the correct tumor type to be treated with tremelimumab.

Tremelimumab may also be used for purposes not listed in this medication guide.

Tell your doctor if you have or have ever had:

• an autoimmune disorder such as Crohn's disease, ulcerative colitis, or lupus; or
• a nerve-muscle disorder, such as myasthenia gravis, or Guillain-Barré syndrome.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while receiving tremelimumab and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 3 months after your last dose.

Use Tremelimumab (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Tremelimumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body (even weeks or months after you've used this medicine). This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• abnormal blood tests;
• nausea, diarrhea;
• feeling weak or tired;
• muscle, bone, or joint pain;
• stomach pain, loss of appetite; or
• itching, rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.