Tislelizumab side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What is the most important information I should know about TEVIMBRA?

TEVIMBRA is a medicine that may treat certain cancers by working with your immune system. TEVIMBRA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with TEVIMBRA. Call or see your healthcare provider right away for new or worsening symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening. […]

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥20%), including laboratory abnormalities, were: TEVIMBRA in combination with platinum-containing chemotherapy: decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased aspartate aminotransferase (AST), decreased potassium, increased serum creatinine, decreased calcium, increased alanine aminotransferase (ALT), diarrhea, stomatitis, and vomiting.

Table 5: Adverse Reactions (≥10%) in Patients With ESCC Receiving TEVIMBRA in RATIONALE-302

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are discussed in more detail in other sections of the label: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥20%), including laboratory abnormalities, were: TEVIMBRA in combination with platinum-containing chemotherapy: decreased neutrophil count, decreased sodium, increased glucose, anemia, fatigue, decreased appetite, increased aspartate aminotransferase (AST), decreased potassium, increased serum creatinine, decreased calcium, increased alanine aminotransferase (ALT), diarrhea, stomatitis, and vomiting. ( 6.1 ) TEVIMBRA as a single agent: 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. ( 6.1 ) TEVIMBRA in combination with platinum and fluoropyrimidine-based chemotherapy: nausea, fatigue, decreased appetite, anemia, peripheral sensory neuropathy, vomiting, decreased platelet count, decreased neutrophil count, increased AST, diarrhea, abdominal pain, increased ALT, decreased white blood cell count, decreased weight, and pyrexia.

What do FAERS reports show?

177 reports list tislelizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 32 are coded as a death and 49 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

• Disease Progression (a use or a product term, not a reaction)64
• Off Label Use (a use or a product term, not a reaction)24
• Malignant Neoplasm Progression22
• Anaemia (named in the label)21
• Lymphadenopathy19
• Thrombocytopenia (named in the label)19
• Richter^S Syndrome10
• Death (an outcome recorded in the report)9
• Pneumonia (named in the label)9
• Pyrexia (named in the label)8
• Decreased Appetite (named in the label)7
• Hyponatraemia7
• Infusion Related Reaction (named in the label)6
• Product Use In Unapproved Indication (a use or a product term, not a reaction)5
• Renal Impairment5
• C-Reactive Protein Increased4
• Hypothyroidism (named in the label)4
• Metastases To Liver4
• Myelosuppression4
• Nausea (named in the label)4
• Neutrophil Count Decreased (named in the label)4
• Alanine Aminotransferase Increased3
• Aspartate Aminotransferase Increased3
• Fall3
• Febrile Neutropenia3

What next?

Tislelizumab: the full record

label, generics, price, shortages, recalls

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