Peringatan Keamanan

There is no information regarding acute toxicity of teclistamab. The maximum tolerated dose of teclistamab has not been determined. In clinical studies, doses of up to 6 mg/kg have been administered. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted immediately.L43597

Teclistamab

DB16655

biotech approved investigational

Deskripsi

Teclistamab is an IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA) expressed on malignant multiple myeloma cells.A253587 Teclistamab consists of an anti-BCMA arm and an anti-CD3 arm connected via two interchain disulfide bonds,A253587, L43622 allowing the drug to recruit CD3-expressing T cells to BCMA-expressing cells to promote T cell–mediated cytotoxicity.A253587

On August 24, 2022, the European Commission (EC) granted conditional marketing authorization of teclistamab as first-in-class bispecific antibody for the treatment of multiple myeloma, marking its first global approval.L43612 Teclistamab was later granted accelerated approval by the FDA on October 25, 2022.L43617

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 non-compartmental analysis, the mean half-life (SD) was 3.8 (1.7) days (individual values ranging up to 8.8 days) following the first treatment intravenous dose of teclistamab.[L43597]
Volume Distribusi The mean (CV%) volume of distribution of teclistamab was 5.63 L (29%). The volume of distribution of teclistamab increases with increasing body weight.[L43622]
Klirens (Clearance) Teclistamab exhibits both time-independent and time-dependent clearance.[L43597] The clearance of teclistamab increases with increasing body weight.[L43622] In a study involving patients receiving step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by a subcutaneous dose of 1.5 mg/kg teclistamab once weekly, the geometric mean (CV%) clearance is 0.472 L/day (64%) at the thirteenth dose. The mean (CV%) maximal reduction from baseline to the thirteenth treatment dose was 40.8% (56%). Patients who discontinue teclistamab-cqyv after the 13th treatment dose are expected to have a 50% reduction from Cmax in teclistamab-cqyv concentration at a median (5th to 95th percentile) time of 15 (7 to 33) days after Tmax and a 97% reduction from Cmax in teclistamab-cqyv concentration at a median time of 69 (32 to 163) days after Tmax.[L43622]

Absorpsi

The mean bioavailability following subcutaneous administration ranges from 69% to 72%.L43597, L43622 A study involved patients with multiple myeloma who received step-up doses of 0.06 mg/kg and 0.3 mg/kg followed by a subcutaneous dose of 1.5 mg/kg teclistamab once weekly. The mean accumulation ratio between the first and thirteenth weekly treatment dose of 1.5 mg/kg teclistamab was 4.2-fold for Cmax, 4.1-fold for Ctrough, and 5.3-fold for AUCtau. The mean (CV%) Cmax after administration of 1.5 mg/kg teclistamab was 23.8 mcg/mL (55%). The median (range) Tmax of teclistamab after the first and thirteenth treatment doses were 139 (19 to 168) hours and 72 (24 to 168) hours, respectively. Most subjects who received a dosage range of 0.08 mg/kg to 3 mg/kg teclistamab reached steady-state exposure after 12 weekly treatment doses.L43622

Metabolisme

Data metabolisme tidak tersedia.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

39 Data
Imlifidase The therapeutic efficacy of Teclistamab can be decreased when used in combination with Imlifidase.
Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Teclistamab.
Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Teclistamab.
Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Teclistamab.
Methoxy polyethylene glycol-epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Teclistamab.
Lidocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Lidocaine.
Ropivacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Ropivacaine.
Bupivacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Bupivacaine.
Cinchocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Cinchocaine.
Dyclonine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Dyclonine.
Procaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Procaine.
Prilocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Prilocaine.
Proparacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Proparacaine.
Meloxicam The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Meloxicam.
Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Oxybuprocaine.
Cocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Cocaine.
Mepivacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Mepivacaine.
Levobupivacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Levobupivacaine.
Diphenhydramine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Diphenhydramine.
Benzocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Benzocaine.
Chloroprocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Chloroprocaine.
Phenol The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Phenol.
Tetrodotoxin The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Tetrodotoxin.
Ambroxol The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Ambroxol.
Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Benzyl alcohol.
Capsaicin The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Capsaicin.
Etidocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Etidocaine.
Articaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Articaine.
Tetracaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Tetracaine.
Propoxycaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Propoxycaine.
Pramocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Pramocaine.
Butamben The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Butamben.
Butacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Butacaine.
Oxetacaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Oxetacaine.
Ethyl chloride The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Ethyl chloride.
Butanilicaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Butanilicaine.
Metabutethamine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Metabutethamine.
Quinisocaine The risk or severity of methemoglobinemia can be increased when Teclistamab is combined with Quinisocaine.
Etrasimod The risk or severity of immunosuppression can be increased when Teclistamab is combined with Etrasimod.

Target Protein

T-cell surface glycoprotein CD3 CD3D
Tumor necrosis factor receptor superfamily member 17 TNFRSF17

Referensi & Sumber

Artikel (PubMed)
  • PMID: 32956453
    Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonca M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F: Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.
  • PMID: 35626122
    Wu L, Huang Y, Sienkiewicz J, Sun J, Guiang L, Li F, Yang L, Golubovskaya V: Bispecific BCMA-CD3 Antibodies Block Multiple Myeloma Tumor Growth. Cancers (Basel). 2022 May 20;14(10). pii: cancers14102518. doi: 10.3390/cancers14102518.
  • PMID: 30147690
    Cho SF, Anderson KC, Tai YT: Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol. 2018 Aug 10;9:1821. doi: 10.3389/fimmu.2018.01821. eCollection 2018.

Contoh Produk & Brand

Produk: 6 • International brands: 0
Produk
  • Tecvayli
    Solution • 30 mg / 3 mL • Subcutaneous • Canada • Approved
  • Tecvayli
    Solution • 153 mg / 1.7 mL • Subcutaneous • Canada • Approved
  • Tecvayli
    Injection • 10 mg/1mL • Subcutaneous • US • Approved
  • Tecvayli
    Injection • 90 mg/1mL • Subcutaneous • US • Approved
  • Tecvayli
    Injection, solution • 10 mg/ml • Subcutaneous • EU • Approved
  • Tecvayli
    Injection, solution • 90 mg/ml • Subcutaneous • EU • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
© 2025 Digital Pharmacy Research - Universitas Esa Unggul