Peringatan Keamanan

A specific nirsevimab overdose treatment is not available. In the event of an overdose, the individual should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate. Preclinical studies of safety pharmacology, repeated dose toxicity and tissue cross-reactivity, did not reveal nirsevimab as a special hazard for humans.L44146

Nirsevimab

DB16258

biotech approved investigational

Deskripsi

Nirsevimab (MEDI8897) is a recombinant human immunoglobulin G1 kappa (IgG1?) monoclonal antibody used to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants.L44146 It binds to the prefusion conformation of the RSV F protein, a glycoprotein involved in the membrane fusion step of the viral entry process, and neutralizes several RSV A and B strains.L44146,A254571 Compared to palivizumab, another anti-RSV antibody, nirsevimab shows greater potency at reducing pulmonary viral loads in animal models. In addition, nirsevimab was developed as a single-dose treatment for all infants experiencing their first RSV season, whereas palivizumab requires five monthly doses to cover an RSV season.A254691 This is due to a modification in the Fc region of nirsevimab that grants it a longer half-time compared to typical monoclonal antibodies.A254571,L44146

On November 2022, nirsevimab was approved by the EMA for the prevention of RSV lower respiratory tract disease in newborns and infants.L44146 Nirsevimab was also approved by Health Canada on April 19, 2023 and by the FDA in July 17, 2023 for the same indication.L46392,L47461

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) The terminal half-life of nirsevimab was approximately 69 days.[L44146]
Volume Distribusi For an infant weighing 5 kg, nirsevimab has a central and peripheral volume of distribution of 249 mL and 241 mL, respectively. The volume of distribution of nirsevimab increases with body weight.[L44146]
Klirens (Clearance) For an infant weighing 5 kg, nirsevimab has an estimated clearance of 3.38 mL/day. The clearance of nirsevimab increases with body weight.[L44146]

Absorpsi

At clinically relevant intramuscular doses (25-300 mg) in infants and adults, nirsevimab follows dose-proportional pharmacokinetics,A254571,L44146 and it reaches maximum concentration within 6 days (range 1 to 28 days) following intramuscular administration. The estimated absolute bioavailability of nirsevimab was 85%.L44146

Metabolisme

As a monoclonal antibody, nirsevimab is expected to be metabolized by proteases throughout the body. It is not metabolized by hepatic enzymes.L44146

Rute Eliminasi

As a monoclonal antibody, nirsevimab is eliminated by intracellular catabolism. At clinical doses, there is no evidence of target-mediated clearance.L44146

Interaksi Obat

1 Data
Imlifidase The therapeutic efficacy of Nirsevimab can be decreased when used in combination with Imlifidase.

Target Protein

Fusion glycoprotein F0 F
Fusion glycoprotein F0 F
Fusion glycoprotein F0 F

Referensi & Sumber

Synthesis reference: Khan, AA et al. (2020) Dosage regimens for and compositions including anti-rsv antibodies. (U.S. Patent No. 2020/0347120 A1). U.S. Patent and Trademark Office. https://patentimages.storage.googleapis.com/6b/d2/10/a841b66e0c90cf/US20200347120A1.pdf
Artikel (PubMed)
  • PMID: 29373476
    Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP: Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.
  • PMID: 26641933
    Battles MB, Langedijk JP, Furmanova-Hollenstein P, Chaiwatpongsakorn S, Costello HM, Kwanten L, Vranckx L, Vink P, Jaensch S, Jonckers TH, Koul A, Arnoult E, Peeples ME, Roymans D, McLellan JS: Molecular mechanism of respiratory syncytial virus fusion inhibitors. Nat Chem Biol. 2016 Feb;12(2):87-93. doi: 10.1038/nchembio.1982. Epub 2015 Dec 7.
  • PMID: 32726528
    Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP: Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556.
  • PMID: 35235726
    Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T: Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.
  • PMID: 35544094
    Venkatesan P: Nirsevimab: a promising therapy for RSV. Lancet Microbe. 2022 May;3(5):e335. doi: 10.1016/S2666-5247(22)00097-0.

Contoh Produk & Brand

Produk: 10 • International brands: 1
Produk
  • Beyfortus
    Solution • 50 mg / 0.5 mL • Intramuscular • Canada • Approved
  • Beyfortus
    Injection, solution • 50 mg • Intramuscular • EU • Approved
  • Beyfortus
    Injection, solution • 50 mg • Intramuscular • EU • Approved
  • Beyfortus
    Injection, solution • 50 mg • Intramuscular • EU • Approved
  • Beyfortus
    Injection • 50 mg/0.5mL • Intramuscular • US • Approved
  • Beyfortus
    Injection, solution • 100 mg • Intramuscular • EU • Approved
  • Beyfortus
    Injection • 100 mg/1mL • Intramuscular • US • Approved
  • Beyfortus
    Injection, solution • 100 mg • Intramuscular • EU • Approved
Menampilkan 8 dari 10 produk.
International Brands
  • Beyfortus — AstraZeneca AB

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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