Peringatan Keamanan

Toxicity information regarding retifanlimab is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects, such as severe and fatal immune-mediated adverse reactions and severe infusion-related reactions.L45603 Symptomatic and supportive measures are recommended. The carcinogenicity and genotoxicity of retifanlimab have not been evaluated in non-clinical studies. In monkeys given 1-month and 3-month repeat doses, retifanlimab did not lead to no notable effects in the male and female reproductive organs; however, most animals were not sexually mature.L45603

Retifanlimab

DB15766

biotech approved investigational

Deskripsi

Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells.L45603 Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab.

On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal.L45608,L45618 On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).L45603,L45613 The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.A258383,A258388

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) At steady-state, retifanlimab has an elimination half-life of 19 days.[L45603]
Volume Distribusi At steady-state, retifanlimab has a mean volume of distribution of 6.0 L.[L45603]
Klirens (Clearance) Following the first dose of retifanlimab, clearance was 0.31 L/day, which decreased by approximately 23% over time. The steady-state clearance of retifanlimab was 0.24 L/day.[L45603]

Absorpsi

The pharmacokinetics of retifanlimab were assessed in patients with different types of solid tumors, including Merkel cell carcinoma (MCC). From 375 mg to 750 mg (0.75- to 1.5-fold of the approved recommended dose), the Cmax and AUC of retifanlimab increased in a dose-proportional manner. In patients given 500 mg of retifanlimab every 4 weeks, steady-state concentrations are reached at cycle 6 (approximately 6 months) with a 1.3-fold systemic accumulation.L45603 Factors such as age, sex, body weight, race, albumin level, renal function and mild hepatic impairment did not have a clinically significant effect on the pharmacogenetic profile of retifanlimab. The pharmacokinetics of retifanlimab have not been evaluated in patients with moderate or severe hepatic impairment.L45603

Metabolisme

As a monoclonal antibody, retifanlimab is expected to be metabolized by proteases throughout the body.

Rute Eliminasi

No excretion studies were performed since, as an antibody, retifanlimab is degraded to small peptides and amino acids.L45608

Interaksi Obat

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

Target Protein

Programmed cell death protein 1 PDCD1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 36091159
    Rao S, Jones M, Bowman J, Tian C, Spano JP: POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.
  • PMID: 36029651
    Catenacci DVT, Kang YK, Yoon HH, Shim BY, Kim ST, Oh DY, Spira AI, Ulahannan SV, Avery EJ, Boland PM, Chao J, Chung HC, Gardner F, Klempner SJ, Lee KW, Oh SC, Peguero J, Sonbol MB, Shen L, Moehler M, Sun J, Li D, Rosales MK, Park H: Margetuximab with retifanlimab as first-line therapy in HER2+/PD-L1+ unresectable or metastatic gastroesophageal adenocarcinoma: MAHOGANY cohort A. ESMO Open. 2022 Oct;7(5):100563. doi: 10.1016/j.esmoop.2022.100563. Epub 2022 Aug 24.

Contoh Produk & Brand

Produk: 2 • International brands: 0
Produk
  • Zynyz
    Injection, solution, concentrate • 500 mg • Intravenous • EU • Approved
  • Zynyz
    Injection • 25 mg/1mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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