Tislelizumab is an antineoplastic biological agent, with the active ingredient being a humanized recombinant anti-PD-1 monoclonal antibody. It mainly helps the immune system recognize and attack cancer cells by blocking the PD-1 signaling pathway.
Indications
The clinically common dosage form is injection, indicated for seven categories of tumor patients who meet the criteria after physician evaluation:
Classical Hodgkin Lymphoma (a malignant tumor occurring in the lymphatic system)；
Urothelial Carcinoma (a common malignant tumor of the urinary system)；
Non-Small Cell Lung Cancer (the major type accounting for approximately 85% of all lung cancer cases)；
Hepatocellular Carcinoma (the most common type of primary liver cancer)；
Microsatellite Instability-High (MSI-H) Solid Tumors (characterized by specific defects in the cellular DNA repair mechanism)；
Esophageal Squamous Cell Carcinoma (a malignant tumor arising from the esophageal mucosa)；
Nasopharyngeal Carcinoma (a malignant tumor occurring in the nasopharyngeal mucosa).
Dosage and Administration
This drug must be used under the full guidance of a specialist with experience in oncology treatment. Patients must follow standardized administration under the supervision of a professional physician and must not self-medicate solely based on this prescribing information.
Dosage Form and Strength
100 mg per vial (equivalent to 100 mg of active ingredient per vial).
Specific Administration
Route of administration: Intravenous infusion (slow infusion via a peripheral vein in the arm).
Standard dosage: 200 mg once every three weeks.
Treatment duration: Continue administration until either of the following occurs: tumor progression or intolerable adverse drug reactions.
When used in combination with chemotherapy: If administered on the same day, complete the intravenous infusion of this drug first before starting chemotherapy.
Note: Prescribing information may vary for similar products manufactured by different pharmaceutical companies. The above content is derived from the current drug label. If discrepancies are found between the actual drug instructions and the above information, contact the attending physician or a professional pharmacist immediately for confirmation.
Adverse Reactions
As an antineoplastic drug, this product must be used under professional medical supervision. Do not adjust the treatment regimen without. authorization.
It may induce immune-related adverse reactions affecting multiple organs and systems, which can be life-threatening in severe cases. These reactions may occur during treatment or after drug withdrawal. Detailed examinations are required to confirm the cause when suspected immune reactions appear. In most cases, drug withdrawal, corticosteroid therapy (e.g., prednisone), or adjuvant treatment can effectively control the reactions.
Immune-Related Adverse Reactions and Management Principles
Immune-related pneumonitis
Main manifestations: Shortness of breath, dyspnea, persistent cough, etc.
Abnormal findings on chest CT (e.g., patchy opacities or ground-glass changes).
Management: Withhold treatment for Grade 2 reactions; permanently discontinue for Grade 3–4 or recurrent Grade 2 reactions. Pulmonary infection or tumor-related effects must be excluded before diagnosis.
Immune-related colitis and enteritis
Main manifestations: Abdominal pain, diarrhea, mucoid or bloody stools.
Management: Withhold treatment for Grade 2 reactions; permanently discontinue for Grade 3–4 or recurrent Grade 3 reactions. Colonoscopy may be arranged to rule out infection or other risks.
Immune-related hepatitis
Liver function should be monitored monthly. Watch for jaundice (yellowing of skin or sclera), significant loss of appetite, or unusual fatigue.
Management: Permanently discontinue for Grade 3–4 reactions. For patients with hepatocellular carcinoma, judgment should be based on pre-treatment liver function.
Immune-related nephritis
Renal function should be monitored monthly. Pay attention to changes in urine output, lower extremity edema, elevated serum creatinine (mostly asymptomatic).
Management: Withhold treatment for Grade 2–3 reactions; permanently discontinue for Grade 4 reactions.
Immune-related endocrinopathies
Common symptoms: Abnormal weight change, tachycardia or bradycardia, etc.
Management: Withhold treatment + hormone replacement for Grade 2–3 reactions; permanently discontinue for Grade 4 reactions. Continuous hormone level monitoring is required.
Hypophysitis: May present with persistent headache, hypogonadism. Management: Withhold treatment + hormone replacement for Grade 2–3 reactions; permanently discontinue for Grade 4 reactions. Diagnosis confirmed by MRI.
Adrenal insufficiency: Symptoms include severe fatigue, skin hyperpigmentation. Management: Withhold treatment + hormone replacement for Grade 2–3 reactions; permanently discontinue for Grade 4 reactions.
Hyperglycemia and Type 1 diabetes mellitus: Unusual thirst, polyuria, sudden weight loss. Management: Permanently discontinue for Grade 4 reactions. Long-term monitoring and standardized insulin therapy are required.
Immune-related skin adverse reactions
Including Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis (SJS/TEN), generalized rash, etc.
Management: Continue treatment + topical ointments for Grade 1–2 rash; withhold treatment for Grade 3 reactions; permanently discontinue for Grade 4 reactions.
Immune-related myocarditis
Manifestations: Palpitations, chest tightness, dyspnea on exertion.
Management: Withhold treatment + corticosteroid therapy for Grade 2 reactions; permanently discontinue for Grade 3–4 reactions. Regular monitoring of myocardial enzymes and cardiac function is required.
Immune-related pancreatitis
Main manifestations: Elevated serum amylase / lipase, epigastric pain.
Management: Withhold treatment for severe enzyme elevation; permanently discontinue for recurrent cases.
Immune-related thrombocytopenia
Observe for skin ecchymosis, petechiae, severe fatigue.
Management: Withhold treatment for severe thrombocytopenia, plus adjuvant thrombopoietic therapy.
Immune-related neurological adverse reactions
Manifestations: Numbness of hands and feet, muscle weakness, dysphagia.
Management: Withhold treatment + neurotrophic agents for Grade 2 reactions; permanently discontinue for Grade 3–4 reactions.
Other immune-related adverse reactions
Ocular uveitis (may cause vision loss): Ophthalmic examination and timely intervention are recommended.
Complications of allogeneic hematopoietic stem cell transplantation in classical Hodgkin lymphoma patients: Graft-versus-host disease (GVHD) may occur. Adequate risk assessment is required before transplantation.
Contraindications
Contraindicated in pregnant women.
The drug ingredient may cross the placenta and affect fetal development. Women at any stage of pregnancy should avoid using this drug.
Precautions
Allergic populations
Caution should be exercised in patients prone to allergic reactions, including but not limited to those with hypersensitivity to the drug ingredients, a history of severe allergies, or allergic constitution. Such patients may experience aggravated allergic reactions (e.g., skin rash, dyspnea). If use is necessary, it must be administered under full medical supervision. Monitor closely during infusion; immediately discontinue and contact medical staff if any discomfort (e.g., pruritus, facial swelling) occurs.
Special populations
Lactating women: Disclose lactation status to the physician promptly. The drug may be excreted into breast milk and affect the infant. Use must be evaluated by a physician for risk-benefit balance.
Pediatric patients: Dosage should be adjusted by a physician based on age, weight, and metabolic characteristics; parents must not administer without authorization.
Elderly patients: Due to declined organ function and slowed metabolism, dosage should be adjusted based on liver and kidney function test results.
Drug interactions
Pay close attention to administration sequence and dosage adjustment when combined with chemotherapy; assess the risk of immune-related adverse reactions when combined with radiotherapy; monitor for overlapping toxicity when combined with targeted agents; evaluate efficacy interactions when combined with traditional Chinese medicine preparations.
Patients receiving other treatments (including surgery, radiotherapy, chemotherapy, targeted therapy, traditional Chinese medicine, etc.) must disclose the full current regimen to the attending physician before use. The physician will comprehensively evaluate the safety and efficacy of combination therapy and make necessary dosage adjustments or monitoring.
General precautions
Strictly follow the physician’s instructions and monitor physical status regularly to ensure safe and effective use. Inform the physician in advance of all concurrent medications and underlying medical conditions.
Medication Tips
This drug is mainly used to improve the overall therapeutic outcome of cancer patients. Common applications include:
Component of systemic therapy for advanced tumors;
Adjuvant therapy to prevent tumor recurrence and metastasis after surgery;
Relief of tumor-related symptoms (e.g., pain or dysfunction caused by tumor compression);
Combination with other treatments to enhance efficacy.
The physician will develop a personalized regimen based on the patient’s condition, symptoms, tumor stage, pathological type, and other factors.
Administration must be preceded by confirmation of eligibility by a professional physician.
