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Tislelizumab

Generic Medicine Info
Indications and Dosage
Intravenous
Non-squamous non-small cell lung cancer
Adult: In combination with pemetrexed and platinum-containing chemotherapy as 1st-line treatment in patients with tumours which have programmed cell death ligand-1 (PD-L1) expression on ≥50% of tumour cells with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive mutations who have locally advanced non-small cell lung cancer (NSCLC) and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC: 200 mg once every 3 weeks. Continue until disease progression or unacceptable toxicity occurs. Doses are given via IV infusion using an IV line containing a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter, initially over 60 minutes. If tolerated, subsequent infusions may be given over 30 minutes. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Squamous non-small cell lung cancer
Adult: In combination with carboplatin and either paclitaxel or nab-paclitaxel as 1st-line treatment in patients with cases who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC: 200 mg once every 3 weeks. Continue until disease progression or unacceptable toxicity occurs. Doses are given via IV infusion using an IV line containing a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter, initially over 60 minutes. If tolerated, subsequent infusions may be given over 30 minutes. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Locally advanced non-small cell lung carcinoma, Metastatic non-small cell lung carcinoma
Adult: As monotherapy after prior platinum-based therapy (patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab): 200 mg once every 3 weeks. Continue until disease progression or unacceptable toxicity occurs. Doses are given via IV infusion using an IV line containing a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter, initially over 60 minutes. If tolerated, subsequent infusions may be given over 30 minutes. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Oesophageal squamous cell carcinoma
Adult: In combination with platinum-based chemotherapy as 1st-line treatment in patients with unresectable, locally advanced or metastatic cases whose tumours expressed PD-L1 with a tumour area positivity (TAP) score of ≥5%; as monotherapy in patients with unresectable, locally advanced or metastatic cases after prior platinum-based chemotherapy: 200 mg once every 3 weeks. Continue until disease progression or unacceptable toxicity occurs. Doses are given via IV infusion using an IV line containing a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter, initially over 60 minutes. If tolerated, subsequent infusions may be given over 30 minutes. Dose interruption or discontinuation may be required according to individual safety or tolerability. Dosing and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).

Intravenous
Gastric adenocarcinoma, Gastro-oesophageal junction adenocarcinoma
Adult: In combination with platinum and fluoropyrimidine-based chemotherapy as 1st-line treatment in patients with human epidermal growth factor receptor type 2 (HER)-2 negative locally advanced unresectable or metastatic cases whose tumours express PD-L1 with a TAP score of ≥5%: 200 mg once every 3 weeks. Continue until disease progression or unacceptable toxicity occurs. Doses are given via IV infusion using an IV line containing a sterile, non-pyrogenic, low-protein binding 0.2 or 0.22 micron in-line or add-on filter, initially over 60 minutes. If tolerated, subsequent infusions may be given over 30 minutes. Dose interruption or discontinuation may be required according to individual safety or tolerability. Dosing and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
What are the brands available for Tislelizumab in Hong Kong?
Reconstitution
Concentrate for solution for infusion: Withdraw appropriate dose and required volume from the vials, then transfer into a NaCl 0.9% solution bag to prepare a final concentration of 2-5 mg/mL. Mix by gentle inversion. Do not shake.
Special Precautions
Patient with active brain or leptomeningeal metastases, active or untreated HIV, history of interstitial lung disease, myasthenia gravis, pre-existing autoimmune disease (AID), allogeneic haematopoietic stem cell transplantation (HSCT); who are untreated hepatitis B or hepatitis C carriers. Pregnancy. Discontinue breastfeeding during therapy and for at least 4 months after the last dose.
Adverse Reactions
Significant: Immune-related reactions such as rash, dermatitis, colitis (frequently associated with diarrhoea), thyroid disorders (e.g. thyroiditis, hypothyroidism, hyperthyroidism), adrenal insufficiency, type 1 diabetes mellitus (including diabetic ketoacidosis), hypophysitis, myositis, myocarditis, arthritis, polymyalgia rheumatica, immune thrombocytopenia, Sjogren's syndrome, myasthenia gravis, Guillain-Barre syndrome, pericarditis and encephalitis; severe infusion-related reactions (including anaphylactic reaction and anaphylactic shock).
Blood and lymphatic system disorders: Anaemia, neutropenia, thrombocytopenia, lymphopenia.
Gastrointestinal disorders: Nausea, stomatitis, pancreatitis.
General disorders and administration site conditions: Fatigue, pyrexia.
Investigations: Increased AST, ALT, blood bilirubin, blood alkaline phosphatase or blood creatinine.
Metabolism and nutrition disorders: Hyperglycaemia, hyponatraemia, hypokalaemia, decreased appetite.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Respiratory, thoracic and mediastinal disorders: Pneumonia, cough, dyspnoea.
Skin and subcutaneous tissue disorders: Pruritus, vitiligo.
Vascular disorders: Hypertension.
Potentially Fatal: Immune-related reactions such as pneumonitis, hepatitis, nephritis with renal dysfunction, severe cutaneous adverse reactions (SCARs) (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), solid organ transplant rejection, and haemophagocytic lymphohistiocytosis (HLH).
Patient Counseling Information
Women of childbearing potential must use effective birth control methods during treatment and for at least 4 months after the last dose.
Monitoring Parameters
Confirm PD-L1 expression status as clinically indicated. Evaluate pregnancy status before treatment initiation. Monitor hepatic function (e.g. ALT, AST, total bilirubin), kidney function and thyroid function at baseline and periodically during treatment; blood glucose. Assess for signs and symptoms of immune-mediated reactions, infusion-related reactions, and transplant-related complications (in patients receiving or have received haematopoietic stem cell transplant).
Drug Interactions
May reduce therapeutic efficacy with systemic corticosteroids.
Action
Description:
Overview: Tislelizumab, an antineoplastic agent, is a humanised anti-programmed-death receptor-1 (anti-PD-1) monoclonal antibody.
Mechanism of Action: Tislelizumab binds to programmed death receptor-1 (PD-1) on T-cells and blocks the interaction of PD-1 with its ligands, programmed cell death ligand-1 (PD-L1) and programmed cell death-ligand 2 (PD-L2). This results in the inhibition of T-cell proliferation and cytokine production, releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumour immune response.
Pharmacodynamics: Exposure-response relationships for efficacy and safety and time course of pharmacodynamic responses of tislelizumab have not been fully characterised.
Pharmacokinetics:
Metabolism: Degraded via catabolic pathways into small peptides and amino acids.
Excretion: Elimination half-life: 24 days.
Storage
Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Diluted solution for IV infusion: May be stored between 20-25°C for up to 4 hours or between 2-8°C for up to 20 hours. Follow applicable procedures for receiving, handling, administration, and disposal.
MIMS Class
Cancer Immunotherapy / Targeted Cancer Therapy
ATC Classification
L01FF09 - tislelizumab ; Belongs to the class of PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.
References
BeiGene NZ Unlimited. Tevimbra 100 mg/10 mL Concentrate for Solution for Infusion data sheet 16 July 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 21/11/2025.

Tevimbra 100 mg Concentrate for Solution for Infusion (BeOne Medicines UK, Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 21/11/2025.

Tevimbra 100 mg/10 mL Concentrate for Solution for Infusion (BeOne Medicines Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 27/11/2025.

Tevimbra Concentrate for Solution for Infusion 100 mg/10 mL (BeOne Medicines [Hong Kong] Co., Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 02/02/2026.

Tevimbra Injection, Solution, Concentrate (BeOne Medicines USA, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 21/11/2025.

Tislelizumab-jsgr. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 21/11/2025.

Tislelizumab. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 21/11/2025.

Tislelizumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 21/11/2025.

Disclaimer: This information is independently developed by MIMS based on Tislelizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2026 MIMS. All rights reserved. Powered by MIMS.com
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