Tislelizumab (a PD-1 inhibitor) is contraindicated mainly in patients with hypersensitivity to the drug components, active autoimmune diseases, uncontrolled severe infections, post-organ transplantation requiring immunosuppressive therapy, pregnancy or lactation, and a history of specific liver dysfunction or immune-related adverse reactions, etc. Details are as follows:
1. Hypersensitivity or intolerance to drug components
Tislelizumab is contraindicated in patients with a history of severe hypersensitivity reactions (e.g., anaphylactic shock, angioedema, etc.) to tislelizumab or its excipients (e.g., mannitol, histidine, etc.). The allergy history must be carefully checked before administration.
2. Active autoimmune diseases
Tislelizumab is contraindicated in patients with uncontrolled active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, etc.). Tislelizumab may activate the immune system and exacerbate pre-existing diseases. For patients with a history of such diseases that have been stabilized by treatment, a physician must evaluate the risks before use.
3. Severe infection or immunosuppressive status
Active infections
such as active pulmonary tuberculosis, untreated chronic hepatitis B virus (HBV) infection with positive DNA, uncontrolled HIV infection, etc. Immunotherapy may increase the risk of infection aggravation.
Long-term use of immunosuppressants
patients requiring anti-rejection medications after organ transplantation or those treated with high-dose corticosteroids, who may face an increased risk of adverse reactions due to excessive immunosuppression.
4. Specific organ dysfunction
Severe hepatic impairment
such as Child-Pugh class C liver cirrhosis or uncontrolled transaminase elevation exceeding 5 times the upper limit of normal, requires caution or contraindication.
History of immune-related adverse reactions
patients who have experienced severe pneumonitis, colitis, myocarditis, etc., following previous immunotherapy (e.g., PD-1/PD-L1 inhibitors), as re-administration may trigger more severe reactions.
5. Pregnancy and lactation
Tislelizumab is contraindicated in pregnant women because animal studies suggest potential fetal harm. Breastfeeding women should discontinue breastfeeding to avoid drug transmission through breast milk.
6. Other special conditions
Interstitial lung disease
patients with uncontrolled non-infectious pneumonitis or pulmonary fibrosis, as immune activation may worsen the condition.
Excluded populations in clinical trials
some patients with other severe comorbidities (e.g., heart failure, uncontrolled diabetes mellitus) may not be eligible for treatment.
Precautions
Even in patients not meeting the above contraindications, close monitoring for immune-related adverse reactions (e.g., thyroid dysfunction, rash, diarrhea, etc.) is required during treatment, with regular assessment of liver and renal function and infection markers.
The specific treatment regimen should be formulated by a physician based on the patient’s individual condition.
