Tislelizumab Side Effects

Applies to tislelizumab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Tislelizumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body.

This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have: a cough, shortness of breath, chest pain, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, 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.

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).

Serious and sometimes fatal reactions may occur 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--right-sided upper stomach pain, 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 permanently discontinued if you have certain side effects.

Common side effects 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.

For healthcare professionals

Applies to tislelizumab: intravenous solution.

General adverse events

The most common (20% or greater) adverse reactions, including laboratory abnormalities, were increased glucose, decreased hemoglobin, decreased lymphocytes, decreased sodium, decreased albumin, increased alkaline phosphatase, anemia, fatigue, increased AST, musculoskeletal pain, decreased weight, increased ALT, and cough. The most frequent serious adverse reactions (2% or greater) were pneumonia, dysphagia, hemorrhage, pneumonitis (including pneumonitis and immune-mediated pneumonitis), and esophageal obstruction.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Myocarditis
• Rare (less than 0.1%): Pericarditis^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (15%), nausea (14%), diarrhea (up to 13%), dysphagia (11%), abdominal pain (11%), vomiting (11%)
• Common (1% to 10%): Stomatitis
• Uncommon (0.1% to 1%): Pancreatitis, colitis
• Frequency not reported: Esophageal obstruction^[Ref]

Dermatologic

• Very common (10% or more): Rash (up to 16%), pruritus (10.6%)
• Uncommon (0.1% to 1%): Severe skin reactions
• Postmarketing reports: Steven-Johnson syndrome, toxic epidermal necrolysis (including fatal cases)^[Ref]

Endocrine

• Very common (10% or more): Hypothyroidism (13%)
• Common (1% to 10%): Hyperthyroidism, thyroiditis
• Uncommon (0.1% to 1%): Adrenal insufficiency, hypophysitis^[Ref]

Hematologic

• Very common (10% or more): Decreased hemoglobin (45%), decreased lymphocytes (43%), decreased albumin (33%), anemia (31%), decreased platelets (11%), hemorrhage (12%), decreased leukocytes (10%)^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 27%), increased ALT (up to 23%), increased bilirubin (up to 11%)
• Common (1% to 10%): Hepatitis^[Ref]

Hypersensitivity

• Common (1% to 10%): Infusion-related reactions^[Ref]

Metabolic

• Very common (10% or more): Increased glucose (up to 46%), decreased sodium (34%), increased alkaline phosphatase (up to 32%), decreased phosphate (15%), decreased potassium (13%), diabetes mellitus (13%), decreased glucose (10%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (24%)
• Common (1% to 10%): Myalgia, arthralgia
• Uncommon (0.1% to 1%): Myositis, arthritis^[Ref]

Ocular

• Uncommon (0.1% to 1%): Uveitis^[Ref]

Other

• Very common (10% or more): Fatigue (up to 28%), decreased weight (23%), pyrexia (16%), decreased appetite (16%)^[Ref]

Renal

• Very common (10% or more): Increased creatinine kinase (13%)
• Common (1% to 10%): Nephritis^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 22%), pneumonia (16%)
• Common (1% to 10%): Pneumonitis, dyspnea^[Ref]

Further information

Tislelizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer