Tislelizumab

Tislelizumab is used in adults to treat esophageal cancer that has spread to other parts of the body (metastatic) or cannot be removed with surgery.

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

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

Tislelizumab helps your immune system fight tumor cells, but it can also harm healthy organs and tissues in your body. This may result in serious or life-threatening side effects affecting your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor immediately if you experience: a cough, shortness of breath, chest pain, changes in vision, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urination, bruising or bleeding, dark urine, yellowing of your skin or eyes, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, or weight gain or loss.

Tell your doctor if you have ever had:

• an autoimmune disorder such as Crohn's disease, ulcerative colitis, lupus;
• an organ transplant, or a stem cell transplant from a donor;
• radiation treatment to the chest area; or
• a nerve-muscle disorder, such as myasthenia gravis, or Guillain-Barré syndrome.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using tislelizumab and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using tislelizumab, and for at least 4 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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).

Serious and sometimes fatal reactions may happen during treatment with tislelizumab or months after your last dose. Call your doctor right away if you have symptoms such as:

• symptoms of brain swelling--confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions).
• lung problems--new or worsening cough, chest pain, feeling short of breath;
• liver problems--pain in the upper right side of your stomach, tiredness, bruising or bleeding, dark urine, yellowing of your skin or eyes;
• signs of a hormonal disorder--frequent or unusual headaches, lack of energy, dizziness, fainting, mood or behavior changes, increased thirst or urination, feeling cold, weight gain, or weight loss;
• kidney problems--little or no urination, swelling in your feet or ankles, blood in your urine;
• (if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling;
• new or worsening skin rash, itching, or blistering;
• fever, swollen glands, body aches;
• chest pain, irregular heartbeats;
• severe muscle weakness, ongoing pain in your muscles or joints;
• numbness or tingling in your hands or feet; or
• vision problems, eye pain or redness.

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

Common side effects of tislelizumab may include:

• pain in your muscles, joints, or bones;
• weight loss;
• fever, cough, shortness of breath;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• hormonal problems;
• rash or itching; or
• headache, dizziness, tiredness.

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.

Tislelizumab is injected into a vein by a healthcare provider.

This medicine must be given slowly, and the infusion can take 30 to 60 minutes to complete.

Tislelizumab is usually given once every 3 weeks. Your doctor will determine how long to treat you with this medicine.

You may be given other medications to treat or prevent certain side effects.

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 tislelizumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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