Peringatan Keamanan

There are no available data on lovotibeglogene autotemcel administration in pregnant women. Consider the risks associated with myeloablative conditioning agents on pregnancy and fertility.^L49256

No reproductive and developmental toxicity studies in animals have been conducted with LYFGENIA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known whether LYFGENIA has the potential to be transferred to the fetus. Therefore, lovotibeglogene autotemcel should not be administered to women who are pregnant, and pregnancy after lovotibeglogene autotemcel infusion should be discussed with the treating physician.^L49256

No carcinogenicity studies have been performed with lovotibeglogene autotemcel.^L49256

Lovotibeglogene autotemcel

DB18680

biotech approved investigational

Deskripsi

Lovotibeglogene autotemcel consists of autologous hematopoietic stem and progenitor cells transduced with the BB305 lentiviral vector encoding a modified ?-globin gene. Specifically, lovotibeglogene autotemcel provides a functional copy of a modified beta-globin gene (?^A-T87Q-globin) that when combined with ?-globin, produces hemoglobins with similar oxygen-binding capacity as wild type hemoglobin. Additionally, the T87Q mutation also inhibits HbS polymerization, thus limiting sickling of red blood cells.A262736,L49256

On December 8, 2023, lovotibeglogene autotemcel was approved by the FDA under the brand name Lyfgenia for the treatment of sickle cell disease (SCD) in patients ages 12 and older who have a history of vaso-occlusive events.^L49266 It was approved alongside exagamglogene autotemcel (Casgevy), another gene therapy, with the two treatments comprising the first cell-based gene therapies for the treatment of SCD in patients 12 years and older to be approved by the FDA.^L49246

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler

Obat Target Gen Interaksi Enzim Transporter Carrier

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

1. Pendahuluan & Konsep

Fitur visualisasi ini dikembangkan menggunakan pendekatan Graph Theory untuk memetakan hubungan polifarmasi dan molekuler. Entitas (Obat, Target, Gen) direpresentasikan sebagai Simpul (Nodes), sedangkan hubungan biologisnya sebagai Sisi (Edges).

2. Sumber Data (Validasi)

Data Obat: Diekstraksi dari elemen drugbank-id dan name pada skema XML DrugBank.
Target Protein: Diambil dari elemen targets/target yang memuat polipeptida sasaran.
Genetik: Disinkronisasi dari sub-elemen gene-name dan varian snp-effects.
Genetik: Jumlah titik node dibatasi pada maksimal 10 (Slice=10) interaksi untuk menghindari tumpukan data.

3. Algoritma Visualisasi

Tata letak grafik menggunakan algoritma Force-Directed Graph (Barnes-Hut). Model fisika ini menerapkan gaya tolak-menolak antar simpul (Gravitasi: -3000) agar tidak tumpang tindih, serta gaya pegas (Spring: 0.04) pada garis penghubung untuk fleksibilitas interaksi.

4. Legenda Visual

Obat Utama (Pusat Analisis)

Target Protein (Mekanisme)

Gen (Faktor Genetik)

Metode ini mendukung analisis Precision Medicine dan evaluasi risiko Drug-Drug Interaction (DDI).

Profil Farmakokinetik

Waktu Paruh (Half-Life) Lovotibeglogene autotemcel is an autologous gene therapy that includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of LYFGENIA is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.[L49256]

Volume Distribusi Lovotibeglogene autotemcel is an autologous gene therapy that includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of LYFGENIA is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.[L49256]

Klirens (Clearance) Lovotibeglogene autotemcel is an autologous gene therapy that includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of LYFGENIA is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.[L49256]

Absorpsi

Lovotibeglogene autotemcel is an autologous gene therapy that includes hematopoietic stem cells (HSCs) that have been genetically modified ex vivo. The nature of LYFGENIA is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.^L49256

Metabolisme

Rute Eliminasi

Interaksi Obat

0 Data

Tidak ada data.

Target Protein

Hemoglobin subunit beta

Referensi & Sumber

Artikel (PubMed)

PMID: 36161320
Kanter J, Thompson AA, Pierciey FJ Jr, Hsieh M, Uchida N, Leboulch P, Schmidt M, Bonner M, Guo R, Miller A, Ribeil JA, Davidson D, Asmal M, Walters MC, Tisdale JF: Lovo-cel gene therapy for sickle cell disease: Treatment process evolution and outcomes in the initial groups of the HGB-206 study. Am J Hematol. 2023 Jan;98(1):11-22. doi: 10.1002/ajh.26741. Epub 2022 Oct 10.

Link

Contoh Produk & Brand

Produk: 1 • International brands: 0

Produk

Lyfgenia

Suspension • 20000000 1/20mL • Intravenous • US • Approved

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.