Tislelizumab Side Effects

Applies to tislelizumab: parenteral injection for iv infusion.

Side effects include:

Most common adverse reactions (≥20%) as a single agent in patients with esophageal cancer: anemia, fatigue, musculoskeletal pain, decreased weight, cough.

Most common (≥20%) adverse reactions in combination with chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count, decreased neutrophil count, increased aspartate aminotransferase, diarrhea, abdominal pain, increased alanine aminotransferase, decreased white blood cell count, decreased weight, pyrexia.

For healthcare professionals

Applies to tislelizumab: intravenous solution.

General adverse events

The most common adverse reactions with this drug were decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased AST, decreased potassium, increased serum creatinine, decreased calcium, increased ALT, diarrhea, stomatitis, vomiting, decreased hemoglobin, decreased lymphocytes, decreased albumin, increased alkaline phosphatase, musculoskeletal pain, decreased weight, cough, nausea, peripheral sensory neuropathy, decreased platelet count, abdominal pain, decreased WBC count, pyrexia, rash, constipation, alopecia, and leukopenia.^[Ref]

Cardiovascular

• Common (1% to 10%): Myocarditis
• Uncommon (0.1% to 1%): Pericarditis, immune-mediated myocarditis
• Frequency not reported: Vasculitis, hypertension, cardiorespiratory arrest, atrial fibrillation, hemorrhagic shock

Myocarditis included myocarditis, immune-mediated myocarditis, and autoimmune myocarditis.

Immune-mediated myocarditis occurred in 0.6% of patients treated with this drug as monotherapy, including grade 4 (0.04%), grade 3 (0.1%), and grade 2 (0.1%) adverse reactions. The median time from first dose to onset of the event was 1.6 months (range: 14 days to 33.6 months), and the median duration of the event was 5.1 months (range: 4 days to 26.4 months).

Clinically significant immune-mediated cardiac/vascular adverse reactions (including myocarditis, pericarditis, vasculitis) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other programmed death receptor-1/ligand-1 (PD-1/PD-L1) blocking antibodies; severe or fatal cases have been reported for some of these adverse reactions.

Dermatologic

• Very common (10% or more): Alopecia (up to 69.5%), rash (up to 25.6%), pruritus (up to 21.8%), palmar-plantar erythrodysesthesia syndrome (up to 19.1%), immune-mediated dermatologic adverse reactions (up to 13%)
• Uncommon (0.1% to 1%): Vitiligo, erythema multiforme
• Rare (0.01% to 0.1%): Stevens-Johnson syndrome
• Frequency not reported: Severe cutaneous adverse reactions
• Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

Rash included dermatitis, acneiform dermatitis, allergic dermatitis, eczema, erythema, psoriasis, rash, follicular rash, maculopapular rash, pruritic rash, erythematous rash, exfoliative dermatitis, papular rash, urticaria, skin exfoliation, drug eruption, macular rash, pustular rash, lichenoid keratosis, hand dermatitis, immune-mediated dermatitis, autoimmune dermatitis, acute febrile neutrophilic dermatosis, erythema nodosum, granulomatous dermatitis, nodular rash, pemphigoid, and transient acantholytic dermatosis.

Immune-mediated dermatologic adverse reactions occurred in 13% of patients treated with this drug as monotherapy, including grade 4 (0.1%), grade 3 (1.1%), and grade 2 (3.4%) adverse reactions. The median time from first dose to onset of the event was 1.5 months (range: 1 day to 36.1 months). The median duration of the event was 2.1 months (range: 1 day to 61.6 months).

Vitiligo included vitiligo, skin hypopigmentation, skin depigmentation, and leukoderma.

Cases of severe cutaneous adverse reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, some with fatal outcome.

Endocrine

• Very common (10% or more): Hypothyroidism (up to 30.8%), immune-mediated hypothyroidism (up to 12.5%)
• Common (1% to 10%): Hyperthyroidism, thyroiditis, immune-mediated hyperthyroidism, immune-mediated thyroiditis
• Uncommon (0.1% to 1%): Adrenal insufficiency, hypophysitis, immune-mediated adrenal insufficiency, immune-mediated hypophysitis
• Frequency not reported: Hypoparathyroidism

Hypothyroidism included hypothyroidism, increased blood thyroid stimulating hormone, immune-mediated hypothyroidism, increased antithyroid antibody, decreased free T4, decreased free T3, decreased T3, decreased thyroid hormones, primary hypothyroidism, central hypothyroidism, and decreased T4.

Immune-mediated hypothyroidism occurred in 12.5% of patients treated with this drug as monotherapy, including grade 4 (0.04%), grade 3 (0.04%), and grade 2 (6.7%) adverse reactions. The median time from first dose to onset of the event was 3.7 months (range: 1 day to 29.9 months), and the median duration of the event was 10.3 months (range: 1 day to 56 months).

Hyperthyroidism included hyperthyroidism, immune-mediated hyperthyroidism, decreased blood thyroid stimulating hormone, increased free T3, increased free T4, increased T4, and increased T3.

Immune-mediated hyperthyroidism occurred in 4.9% of patients treated with this drug as monotherapy, including grade 3 (0.04%) and grade 2 (0.9%) adverse reactions. The median time from first dose to onset of the event was 2.1 months (range: 6 days to 39.4 months), and the median duration of the event was 2.1 months (range: 8 days to 48.4 months).

Thyroiditis included thyroiditis, autoimmune thyroiditis, immune-mediated thyroiditis, silent thyroiditis, and subacute thyroiditis.

Immune-mediated thyroiditis occurred in 1% of patients treated with this drug as monotherapy, including grade 2 (0.5%) adverse reactions. The median time from first dose to onset of the event was 2 months (range: 14 days to 20.7 months), and the median duration of the event was 7.3 months (range: 20 days to 34.5 months).

Adrenal insufficiency included adrenal insufficiency, Addison's disease, glucocorticoid deficiency, immune-mediated adrenal insufficiency, primary adrenal insufficiency, and secondary adrenocortical insufficiency.

Immune-mediated adrenal insufficiency occurred in 0.5% of patients treated with this drug as monotherapy, including grade 4 (0.04%), grade 3 (0.2%), and grade 2 (0.3%) adverse reactions. The median time from first dose to onset of the event was 9.7 months (range: 1.4 months to 16.9 months), and the median duration of the event was not reached (range: 1 month to 27.9 months).

Hypophysitis included hypopituitarism and lymphocytic hypophysitis.

Immune-mediated hypophysitis/hypopituitarism occurred in 0.3% of patients treated with this drug as monotherapy; all were grade 2 adverse reactions. The median time from first dose to onset of the event was 8.7 months (range: 22 days to 16.2 months), and the median duration of the event was not reached (range: 70 days to 30 months).

Clinically significant immune-mediated endocrine adverse reactions (including hypoparathyroidism) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Gastrointestinal

• Very common (10% or more): Nausea (up to 58.6%), vomiting (up to 41.4%), constipation (up to 34.6%), diarrhea (up to 28.1%), stomatitis (up to 22%), abdominal pain (up to 15.3%), dysphagia (up to 14%), abdominal distension (up to 10%), upper abdominal pain (up to 10%)
• Common (1% to 10%): Esophageal stenosis, gastrointestinal hemorrhage, pancreatitis, colitis
• Uncommon (0.1% to 1%): Immune-mediated colitis
• Frequency not reported: Gastritis, duodenitis, esophageal obstruction, upper gastrointestinal hemorrhage, immune-mediated enterocolitis

Diarrhea included diarrhea, colitis, and frequent bowel movements.

Stomatitis included stomatitis, mouth ulceration, oral mucosa erosion, and aphthous ulcer.

Abdominal pain included upper abdominal pain, abdominal pain, abdominal discomfort, lower abdominal pain, and gastrointestinal pain.

Pancreatitis included increased amylase, increased lipase, pancreatitis, autoimmune pancreatitis, and acute pancreatitis.

Colitis included colitis, immune-mediated enterocolitis, ulcerative colitis, and autoimmune colitis.

Immune-mediated colitis occurred in 0.8% of patients treated with this drug as monotherapy, including grade 3 (0.3%) and grade 2 (0.4%) adverse reactions. The median time from first dose to onset of the event was 6 months (range: 6 days to 26.5 months), and the median duration of the event was 26 days (range: 5 days to 26.7 months).

Clinically significant immune-mediated gastrointestinal adverse reactions (including pancreatitis [including increases in serum amylase and lipase levels], gastritis, duodenitis, stomatitis) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Hematologic

• Very common (10% or more): Anemia (up to 94.1%), decreased hemoglobin (up to 82%), decreased neutrophil count (up to 79.7%), decreased leukocytes (up to 76.5%), decreased WBC count (up to 71.2%), decreased lymphocytes (up to 61.5%), decreased platelet count (up to 60.4%), leukopenia (up to 55.9%), neutropenia (up to 44.2%), thrombocytopenia (up to 41.5%), hemorrhage (up to 12%)
• Common (1% to 10%): Increased hemoglobin, increased lymphocytes
• Rare (0.01% to 0.1%): Immune thrombocytopenia
• Frequency not reported: Hemolytic anemia, aplastic anemia, histiocytic necrotizing lymphadenitis, febrile neutropenia

Hemorrhage included tumor hemorrhage, upper gastrointestinal hemorrhage, gastrointestinal hemorrhage, hemoptysis, esophageal hemorrhage, hematuria, gastric hemorrhage, epistaxis, tracheal hemorrhage, gingival bleeding, pulmonary hemorrhage, procedural hemorrhage, rectal hemorrhage, stoma site hemorrhage.

Clinically significant immune-mediated hematologic adverse reactions (including hemolytic anemia, aplastic anemia, histiocytic necrotizing lymphadenitis [Kikuchi lymphadenitis], immune thrombocytopenia) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Hepatic

• Very common (10% or more): Increased AST (up to 58%), increased ALT (up to 51.8%), increased blood bilirubin (up to 26.3%)
• Common (1% to 10%): Hepatitis, immune-mediated hepatitis
• Frequency not reported: Hepatic failure, abnormal hepatic function

Increased blood bilirubin included increased blood bilirubin, increased conjugated bilirubin, increased unconjugated blood bilirubin, and hyperbilirubinemia.

Hepatitis included hepatitis, hepatotoxicity, abnormal hepatic function, immune-mediated hepatitis, drug-induced liver injury, liver injury, and autoimmune hepatitis.

Immune-mediated hepatitis occurred in 1.3% of patients treated with this drug as monotherapy, including grade 4 (0.3%), grade 3 (0.6%), and grade 2 (0.3%) adverse reactions. The median time from first dose to onset of the event was 1.1 months (range: 14 days to 34.8 months), and the median duration of the event was 1.9 months (range: 6 days to 6.6 months).

Hypersensitivity

• Postmarketing reports: Anaphylaxis, anaphylactic reaction, anaphylactic shock

Immunologic

• Very common (10% or more): Antidrug antibodies (up to 25.3%)
• Common (1% to 10%): Neutralizing antibodies
• Frequency not reported: Hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, sarcoidosis, solid organ transplant rejection, other transplant rejection

Clinically significant immune-mediated immunologic adverse reactions (including hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis [Kikuchi lymphadenitis], sarcoidosis, solid organ transplant rejection, other transplant [including corneal graft] rejection) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Metabolic

• Very common (10% or more): Decreased sodium (up to 67%), increased glucose (up to 65%), decreased appetite (up to 48.1%), decreased albumin (up to 46.7%), decreased potassium (up to 33%), hyponatremia (up to 30.8%), decreased calcium (up to 29%), hypoalbuminemia (up to 25%), hypokalemia (up to 22.6%), decreased phosphate (up to 15%), increased potassium (up to 13.8%), hypochloremia (up to 11.1%), hyperglycemia (up to 10.5%), decreased glucose (up to 10%)
• Common (1% to 10%): Diabetes mellitus, increased sodium
• Frequency not reported: Electrolyte imbalance

Hypokalemia included hypokalemia and decreased blood potassium.

Hyperglycemia included hyperglycemia and increased blood glucose.

Diabetes mellitus included diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, diabetic ketosis, ketoacidosis, and latent autoimmune diabetes in adults. Diabetes mellitus occurred in 0.7% of patients treated with this drug as monotherapy, including grade 4 (0.1%), grade 3 (0.3%), and grade 2 (0.3%) adverse reactions. The median time from first dose to onset of the event was 6.5 months (range: 22 days to 36.1 months), and the median duration of the event was not reached (range: 2 days to 44.5 months).

Musculoskeletal

• Very common (10% or more): Pain in extremity (up to 33.3%), musculoskeletal pain (up to 24%), increased blood creatine phosphokinase (up to 23.9%), arthralgia (up to 21.7%), back pain (up to 10.2%)
• Common (1% to 10%): Myalgia, arthritis
• Uncommon (0.1% to 1%): Myositis, Sjogren's syndrome
• Frequency not reported: Polymyositis, dermatomyositis, rhabdomyolysis, polymyalgia rheumatica

Musculoskeletal pain included musculoskeletal pain, spinal pain, arthralgia, back pain, neck pain, musculoskeletal chest pain, myalgia, pain in extremity, noncardiac chest pain, bone pain, and arthritis.

Arthritis included arthritis, immune-mediated arthritis, and polyarthritis.

Myositis included myositis, immune-mediated myositis, rhabdomyolysis, and polymyalgia rheumatica.

Immune-mediated myositis/rhabdomyolysis occurred in 0.7% of patients treated with this drug as monotherapy, including grade 4 (0.04%), grade 3 (0.2%), and grade 2 (0.2%) adverse reactions. The median time from first dose to onset of the event was 1.6 months (range: 15 days to 39.3 months), and the median duration of the event was 43 days (range: 5 days to 5.2 months).

Clinically significant immune-mediated musculoskeletal and connective tissue adverse reactions (including myositis/polymyositis/dermatomyositis, rhabdomyolysis [and associated sequelae, including renal failure], arthritis, polymyalgia rheumatica) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Nervous system

• Very common (10% or more): Peripheral sensory neuropathy (up to 23.1%), hypoesthesia (up to 22.5%)
• Rare (0.01% to 0.1%): Guillain-Barre syndrome, encephalitis, myasthenia gravis
• Frequency not reported: Meningitis, myelitis, demyelination, myasthenic syndrome, nerve paresis, autoimmune neuropathy, brain injury, traumatic intracranial hemorrhage, cerebellar hemorrhage, cerebrovascular accident, hydrocephalus, subdural hematoma

Encephalitis included immune-mediated encephalitis.

Clinically significant immune-mediated nervous system adverse reactions (including meningitis, encephalitis, myelitis, demyelination, myasthenic syndrome/myasthenia gravis [including exacerbation], Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy, aseptic meningitis, paraneoplastic encephalomyelitis, chronic inflammatory demyelinating polyradiculoneuropathy, peripheral neuropathy, central nervous system inflammation) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies.

Ocular

• Uncommon (0.1% to 1%): Uveitis
• Frequency not reported: Iritis, other ocular inflammatory toxicities, retinal detachment, visual impairment, Vogt-Koyanagi-Harada-like syndrome

Uveitis included uveitis, iritis, iridocyclitis, and chorioretinitis.

Clinically significant immune-mediated ocular adverse reactions (including uveitis, iritis, other ocular inflammatory toxicities) occurred at an incidence of less than 1% in patients who received this drug or were reported with the use of other PD-1/PD-L1 blocking antibodies. Some cases were associated with retinal detachment, and various grades of visual impairment (including blindness) have occurred.

Oncologic

• Frequency not reported: Myelodysplastic syndrome

Other

• Very common (10% or more): Fatigue (up to 45%), increased alkaline phosphatase (up to 32.6%), decreased weight (up to 29%), pyrexia (up to 26.3%), asthenia (up to 25%), malaise (up to 21.8%)
• Common (1% to 10%): Infusion-related reactions
• Frequency not reported: Death, sepsis, multiple organ dysfunction syndrome, sudden death, accidental death

Fatigue included asthenia, fatigue, malaise, and lethargy.

Pyrexia included increased body temperature and pyrexia.

Infusion-related reaction included rash, infusion-related reaction, chills, erythematous rash, allergic rhinitis, urticaria, drug hypersensitivity, laryngeal edema, laryngeal obstruction, macular rash, pruritic rash, swelling face, anaphylactic reaction, corneal edema, allergic dermatitis, drug eruption, face edema, gingival swelling, lip edema, lip swelling, mouth swelling, allergic pruritus, tongue edema, hypersensitivity, and type I hypersensitivity. Infusion-related reactions occurred in 4.7% of patients treated with this drug as monotherapy, including grade 4 (0.04%), grade 3 (0.1%), and grade 2 (1.5 %) reactions.

Renal

• Very common (10% or more): Increased serum creatinine (up to 33%)
• Uncommon (0.1% to 1%): Nephritis, immune-mediated nephritis with renal dysfunction
• Postmarketing reports: Immune-mediated cystitis

Nephritis included nephritis, focal segmental glomerulosclerosis, membranous glomerulonephritis, tubulointerstitial nephritis, immune-mediated renal disorder, and immune-mediated nephritis.

Immune-mediated nephritis with renal dysfunction occurred in 0.2% of patients treated with this drug as monotherapy, including grade 3 (0.04%) and grade 2 (0.1%) adverse reactions. The median time from first dose to onset of the event was 2.1 months (range: 15 days to 34.5 months), and the median duration of the event was not reached (range: 9 days to 16.2 months).

Respiratory

• Very common (10% or more): Cough (up to 22%), pneumonia (up to 21.7%), hemoptysis (up to 20%), dyspnea (up to 11.4%)
• Common (1% to 10%): Pneumonitis, immune-mediated pneumonitis, COVID-19
• Frequency not reported: Pulmonary embolism, respiratory failure, acquired tracheoesophageal fistula, aspiration pneumonia, pulmonary tuberculosis, bronchiectasis, pulmonary arterial hypertension, pulmonary hemorrhage, asphyxia, interstitial lung disease, pleural effusion, bacterial pneumonia, viral respiratory tract infection, hypoxia

Cough included productive cough and cough.

Pneumonia included aspiration pneumonia, pneumonia, bacterial pneumonia, and lower respiratory tract.

Pneumonitis included pneumonitis, interstitial lung disease, immune-mediated pneumonitis, immune-mediated lung disease, and organizing pneumonia.

Immune-mediated pneumonitis occurred in 4.7% of patients treated with this drug as monotherapy, including fatal (0.1%), grade 4 (0.3%), grade 3 (1.4%), and grade 2 (1.9%) adverse reactions. The median time from first dose to onset of the event was 3.9 months (range: 1 day to 55 months), and the median duration of the event was 6 months (range: 1 day to 48.3 months).

See also:

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.

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