Peringatan Keamanan

There are no available data on the use of tislelizumab in pregnant women. Based on its mechanism of action, tislelizumab can cause fetal harm when administered to a pregnant woman.L49349

Animal reproduction studies have not been conducted with tislelizumab. However, in murine models of pregnancy, blockade of PD-1/PD-L1 signaling has been shown to disrupt tolerance to the fetus and result in increased fetal loss.L49349

Human IgG4 (immunoglobulins) are known to cross the placental barrier. Therefore, tislelizumab, being an IgG4 variant, has the potential to be transmitted from the mother to the developing fetus.L49349

Women should be advised of the potential risk to a fetus. Tislelizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with tislelizumab.L49349

No clinical data are available on the possible effects of tislelizumab on fertility. No reproductive and development toxicity studies have been conducted with tislelizumab. Based on a 3-month repeat-dose toxicity study, there were no notable effects in the male and female reproductive organs in cynomolgus monkeys when tislelizumab was given at doses of 3, 10, or 30 mg/kg every 2 weeks for 13 weeks (7 dose administrations).L49349

There is no information on overdose with tislelizumab. In case of overdose, patients should be closely monitored for signs or symptoms of adverse drug reactions, and appropriate symptomatic treatment should be instituted immediately.L49349

Tislelizumab

DB14922

biotech approved investigational

Deskripsi

Tislelizumab is a humanized monoclonal IgG4 antibody against programmed death receptor-1 (PD-1). It was engineered to have a nullified Fc portion, thus minimizing binding to Fc?R on macrophages and limiting treatment resistance via antibody-dependent phagocytosis.A262909 By blocking PD-L1/PD-L2–mediated cell signaling, tislelizumab restores T-cell function through cytokine production, resulting in immune-mediated antitumor responses.A262919 Tislelizumab is generally well tolerated with manageable and mild-to-moderate adverse effects.A262924

On September 25, 2023, tislelizumab gained EMA approval as a monotherapy for adults with esophageal cancer under the brand name TEVIMBRA. This approval was based on positive results demonstrated in the RATIONALE 302 study, where an 8.6-month median overall survival rate was observed for tislelizumab treatment compared to 6.3-month for chemotherapy.L49439 Tislelizumab was also approved by the FDA on March 14, 2024.L50346

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) Based on population PK analysis, the geometrical mean terminal half-life of tislelizumab was approximately 23.8 days with a coefficient variation (CV) of 31%.[L49349]
Volume Distribusi A population pharmacokinetic analysis indicates that the steady-state volume of distribution is 6.42 L, which is typical of monoclonal antibodies with limited distribution.[L49349]
Klirens (Clearance) Based on population PK analysis, the clearance of tislelizumab was 0.153 l/day with an interindividual variability of 26.3%.[L49349]

Absorpsi

The pharmacokinetics (PK) of tislelizumab were characterized using population PK analysis with concentration data from 2 596 patients with advanced malignancies who received tislelizumab doses of 0.5 to 10 mg/kg every 2 weeks, 2.0 and 5.0 mg/kg every 3 weeks, and 200 mg every 3 weeks.L49349 The time to reach 90% steady-state level is approximately 84 days (12 weeks) after 200 mg doses once every 3 weeks, and the steady-state accumulation ratio of tislelizumab PK exposure is approximately 2-fold.L49349 Tislelizumab is administered intravenously and therefore is immediately and completely bioavailable.L49349

Metabolisme

Tislelizumab is expected to be degraded into small peptides and amino acids via catabolic pathways.L49349

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

411 Data
Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tislelizumab.
Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tislelizumab.
Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Tislelizumab.
Methoxy polyethylene glycol-epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Tislelizumab.
Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Tislelizumab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Tislelizumab.
Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Tislelizumab.
Estrone Estrone may increase the thrombogenic activities of Tislelizumab.
Estradiol Estradiol may increase the thrombogenic activities of Tislelizumab.
Dienestrol Dienestrol may increase the thrombogenic activities of Tislelizumab.
Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Tislelizumab.
Mestranol Mestranol may increase the thrombogenic activities of Tislelizumab.
Estriol Estriol may increase the thrombogenic activities of Tislelizumab.
Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Tislelizumab.
Quinestrol Quinestrol may increase the thrombogenic activities of Tislelizumab.
Hexestrol Hexestrol may increase the thrombogenic activities of Tislelizumab.
Tibolone Tibolone may increase the thrombogenic activities of Tislelizumab.
Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Tislelizumab.
Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Tislelizumab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Tislelizumab.
Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Tislelizumab.
Zeranol Zeranol may increase the thrombogenic activities of Tislelizumab.
Equol Equol may increase the thrombogenic activities of Tislelizumab.
Estetrol Estetrol may increase the thrombogenic activities of Tislelizumab.
Promestriene Promestriene may increase the thrombogenic activities of Tislelizumab.
Methallenestril Methallenestril may increase the thrombogenic activities of Tislelizumab.
Epimestrol Epimestrol may increase the thrombogenic activities of Tislelizumab.
Moxestrol Moxestrol may increase the thrombogenic activities of Tislelizumab.
Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Tislelizumab.
Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Tislelizumab.
Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Tislelizumab.
Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Tislelizumab.
Biochanin A Biochanin A may increase the thrombogenic activities of Tislelizumab.
Formononetin Formononetin may increase the thrombogenic activities of Tislelizumab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Tislelizumab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Tislelizumab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Tislelizumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Tislelizumab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Tislelizumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Tislelizumab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Tislelizumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Tislelizumab.
Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Tislelizumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Tislelizumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Tislelizumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Tislelizumab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Tislelizumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Tislelizumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Tislelizumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Tislelizumab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Tislelizumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Tislelizumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Tislelizumab.
Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Tislelizumab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Tislelizumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Tislelizumab.
Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Tislelizumab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Tislelizumab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Tislelizumab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Tislelizumab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Tislelizumab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Tislelizumab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Tislelizumab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Tislelizumab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Tislelizumab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Tislelizumab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Tislelizumab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Tislelizumab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Tislelizumab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Tislelizumab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Tislelizumab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Tislelizumab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Tislelizumab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Tislelizumab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Tislelizumab.
Hepatitis B immune globulin The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Tislelizumab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Tislelizumab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Tislelizumab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Tislelizumab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Tislelizumab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Tislelizumab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Tislelizumab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Tislelizumab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Tislelizumab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Tislelizumab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Tislelizumab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Tislelizumab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Tislelizumab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Tislelizumab.
Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Tislelizumab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Tislelizumab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Tislelizumab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Tislelizumab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Tislelizumab.
Stamulumab The risk or severity of adverse effects can be increased when Stamulumab is combined with Tislelizumab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Tislelizumab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Tislelizumab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Tislelizumab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Tislelizumab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Tislelizumab.

Target Protein

Programmed cell death protein 1 PDCD1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 35442766
    Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E: Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.
  • PMID: 29687231
    Zhang T, Song X, Xu L, Ma J, Zhang Y, Gong W, Zhang Y, Zhou X, Wang Z, Wang Y, Shi Y, Bai H, Liu N, Yang X, Cui X, Cao Y, Liu Q, Song J, Li Y, Tang Z, Guo M, Wang L, Li K: The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018 Jul;67(7):1079-1090. doi: 10.1007/s00262-018-2160-x. Epub 2018 Apr 23.
  • PMID: 32540858
    Desai J, Deva S, Lee JS, Lin CC, Yen CJ, Chao Y, Keam B, Jameson M, Hou MM, Kang YK, Markman B, Lu CH, Rau KM, Lee KH, Horvath L, Friedlander M, Hill A, Sandhu S, Barlow P, Wu CY, Zhang Y, Liang L, Wu J, Paton V, Millward M: Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. J Immunother Cancer. 2020 Jun;8(1):e000453. doi: 10.1136/jitc-2019-000453.

Contoh Produk & Brand

Produk: 5 • International brands: 0
Produk
  • Tevimbra
    Injection, solution, concentrate • 10 mg/1mL • Intravenous • US • Approved
  • Tevimbra
    Injection, solution, concentrate • 10 mg/ml • Intravenous • EU • Approved
  • Tevimbra
    Injection, solution, concentrate • 10 mg/ml • Intravenous • EU • Approved
  • Tizveni
    Injection, solution, concentrate • 100 mg • Intravenous • EU
  • Tizveni
    Injection, solution, concentrate • 100 mg • Intravenous • EU

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