Tremelimumab

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

Tremelimumab may be used along with other cancer treatments when the cancer has spread to other areas of the body (metastatic) or cannot be taken out with surgery.

Your doctor will confirm that you have the right tumor type to be treated with tremelimumab.

Tremelimumab may also be used for reasons not mentioned in this medication guide.

Tremelimumab helps your immune system target tumor cells, but it might also harm healthy organs and tissues in your body (even weeks or months after you have used this medicine). This could result in serious or life-threatening side effects.

Tell your doctor if you have or have ever had:

• an autoimmune disorder like 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 confirm 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 tremelimumab and for at least 3 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, trouble 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 tremelimumab). 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 stopped if you have certain side effects.

Common side effects of tremelimumab 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.

Tremelimumab is injected into a vein. A healthcare provider will give you this injection.

Your doctor will determine your treatment schedule and cycles of treatment.

After receiving an injection, you will be watched closely to make sure you do not have serious side effects.

You may be given other medications to help treat serious side effects. Keep taking these medicines for as long as your doctor has prescribed.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need frequent medical tests and your cancer treatments may be delayed based on the results.

Call your doctor for guidance if you miss an appointment for your tremelimumab injection.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect tremelimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.