Peringatan Keamanan

There are limited amount of data on the use of lebrikizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy.L49369

The mutagenic potential of lebrikizumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.L49369

Carcinogenicity studies have not been conducted with lebrikizumab. Evaluation of the available evidence related to IL-13 inhibition and animal toxicology data with lebrikizumab does not suggest carcinogenic potential for lebrikizumab.L49369

Single intravenous doses up to 10 mg/kg and multiple subcutaneous doses up to 500 mg have been administered to humans in clinical trials without dose-limiting toxicity. There is no specific treatment for lebrikizumab overdose. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.L49369

Lebrikizumab

DB11914

biotech approved investigational

Deskripsi

Lebrikizumab is a monoclonal antibody that binds to IL-13 with high affinity and slow off-rate.L51374 It binds to a different epitope compared tralokinumab.A262874,A262879

On November 17, 2023, lebrikizumab was approved by the EMA under the brand name EBGLYSS for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older with a body weight of at least 40 kg. This approval is based on the positive results obtained from the Phase 3 studies ADvocate 1 and ADvocate 2, where nearly 80% of patients taking lebrikizumab either as monotherapy or combination therapy with topical corticosteroid achieved skin clearance, itch relief and reduced disease severity by week 16.L49404 Lebrikizumab was also approved by the FDA on September 13, 2024.L51379

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 mean elimination half-life was approximately 24.5 days.[L49369]
Volume Distribusi Based on a population PK analysis, the total volume of distribution at steady-state was 5.14 L.[L49369]
Klirens (Clearance) In the population PK analysis, clearance was 0.154 L/day and was independent of dose.[L49369]

Absorpsi

After a subcutaneous dose of 250 mg lebrikizumab, peak serum concentrations were achieved approximately 7 to 8 days post-dose.L49369 Following the 500 mg loading doses at week 0 and week 2, steady-state serum concentrations were achieved with the first 250 mg Q2W dose at week 4.L49369 Based on a population pharmacokinetic (PK) analysis, the predicted steady-state trough concentrations (Ctrough,ss) following lebrikizumab 250 mg Q2W and Q4W subcutaneous dosing in patients with atopic dermatitis (median and 5th - 95th percentile) were 87 (46-159) µg/mL and 36 (18-68) µg/mL, respectively.L49369 The absolute bioavailability was estimated at 86% based on a population PK analysis. The injection site location did not significantly influence the absorption of lebrikizumab.L49369

Metabolisme

Specific metabolism studies were not conducted because lebrikizumab is a protein. Lebrikizumab is expected to degrade to small peptides and individual amino acids via catabolic pathways in the same manner as endogenous IgG.L49369

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

373 Data
Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Lebrikizumab.
Chlorotrianisene Chlorotrianisene may increase the thrombogenic activities of Lebrikizumab.
Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Lebrikizumab.
Estrone Estrone may increase the thrombogenic activities of Lebrikizumab.
Estradiol Estradiol may increase the thrombogenic activities of Lebrikizumab.
Dienestrol Dienestrol may increase the thrombogenic activities of Lebrikizumab.
Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Lebrikizumab.
Mestranol Mestranol may increase the thrombogenic activities of Lebrikizumab.
Estriol Estriol may increase the thrombogenic activities of Lebrikizumab.
Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Lebrikizumab.
Quinestrol Quinestrol may increase the thrombogenic activities of Lebrikizumab.
Hexestrol Hexestrol may increase the thrombogenic activities of Lebrikizumab.
Tibolone Tibolone may increase the thrombogenic activities of Lebrikizumab.
Synthetic Conjugated Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Lebrikizumab.
Synthetic Conjugated Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Lebrikizumab.
Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Lebrikizumab.
Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Lebrikizumab.
Zeranol Zeranol may increase the thrombogenic activities of Lebrikizumab.
Equol Equol may increase the thrombogenic activities of Lebrikizumab.
Promestriene Promestriene may increase the thrombogenic activities of Lebrikizumab.
Methallenestril Methallenestril may increase the thrombogenic activities of Lebrikizumab.
Epimestrol Epimestrol may increase the thrombogenic activities of Lebrikizumab.
Moxestrol Moxestrol may increase the thrombogenic activities of Lebrikizumab.
Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Lebrikizumab.
Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Lebrikizumab.
Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Lebrikizumab.
Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Lebrikizumab.
Biochanin A Biochanin A may increase the thrombogenic activities of Lebrikizumab.
Formononetin Formononetin may increase the thrombogenic activities of Lebrikizumab.
Estetrol Estetrol may increase the thrombogenic activities of Lebrikizumab.
Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Lebrikizumab.
Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Lebrikizumab.
Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Lebrikizumab.
Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Lebrikizumab.
Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Lebrikizumab.
Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Lebrikizumab.
Indium In-111 satumomab pendetide The risk or severity of adverse effects can be increased when Indium In-111 satumomab pendetide is combined with Lebrikizumab.
Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Lebrikizumab.
Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Lebrikizumab.
Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Lebrikizumab.
Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Lebrikizumab.
Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Lebrikizumab.
Digoxin Immune Fab (Ovine) The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Lebrikizumab.
Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Lebrikizumab.
Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Lebrikizumab.
Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Lebrikizumab.
Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Lebrikizumab.
Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Lebrikizumab.
Antithymocyte immunoglobulin (rabbit) The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Lebrikizumab.
Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Lebrikizumab.
Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Lebrikizumab.
Daclizumab The risk or severity of adverse effects can be increased when Daclizumab is combined with Lebrikizumab.
Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Lebrikizumab.
Technetium Tc-99m arcitumomab The risk or severity of adverse effects can be increased when Technetium Tc-99m arcitumomab is combined with Lebrikizumab.
Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Lebrikizumab.
Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Lebrikizumab.
Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Lebrikizumab.
Galiximab The risk or severity of adverse effects can be increased when Galiximab is combined with Lebrikizumab.
Pexelizumab The risk or severity of adverse effects can be increased when Pexelizumab is combined with Lebrikizumab.
Afelimomab The risk or severity of adverse effects can be increased when Afelimomab is combined with Lebrikizumab.
Epratuzumab The risk or severity of adverse effects can be increased when Epratuzumab is combined with Lebrikizumab.
Bectumomab The risk or severity of adverse effects can be increased when Bectumomab is combined with Lebrikizumab.
Oregovomab The risk or severity of adverse effects can be increased when Oregovomab is combined with Lebrikizumab.
IGN311 The risk or severity of adverse effects can be increased when IGN311 is combined with Lebrikizumab.
Adecatumumab The risk or severity of adverse effects can be increased when Adecatumumab is combined with Lebrikizumab.
Labetuzumab The risk or severity of adverse effects can be increased when Labetuzumab is combined with Lebrikizumab.
Matuzumab The risk or severity of adverse effects can be increased when Matuzumab is combined with Lebrikizumab.
Fontolizumab The risk or severity of adverse effects can be increased when Fontolizumab is combined with Lebrikizumab.
Bavituximab The risk or severity of adverse effects can be increased when Bavituximab is combined with Lebrikizumab.
CR002 The risk or severity of adverse effects can be increased when CR002 is combined with Lebrikizumab.
Rozrolimupab The risk or severity of adverse effects can be increased when Rozrolimupab is combined with Lebrikizumab.
Girentuximab The risk or severity of adverse effects can be increased when Girentuximab is combined with Lebrikizumab.
Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Lebrikizumab.
XTL-001 The risk or severity of adverse effects can be increased when XTL-001 is combined with Lebrikizumab.
NAV 1800 The risk or severity of adverse effects can be increased when NAV 1800 is combined with Lebrikizumab.
Briakinumab The risk or severity of adverse effects can be increased when Briakinumab is combined with Lebrikizumab.
Otelixizumab The risk or severity of adverse effects can be increased when Otelixizumab is combined with Lebrikizumab.
AMG 108 The risk or severity of adverse effects can be increased when AMG 108 is combined with Lebrikizumab.
Iratumumab The risk or severity of adverse effects can be increased when Iratumumab is combined with Lebrikizumab.
Enokizumab The risk or severity of adverse effects can be increased when Enokizumab is combined with Lebrikizumab.
Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Lebrikizumab.
Farletuzumab The risk or severity of adverse effects can be increased when Farletuzumab is combined with Lebrikizumab.
Veltuzumab The risk or severity of adverse effects can be increased when Veltuzumab is combined with Lebrikizumab.
Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Lebrikizumab.
Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Lebrikizumab.
PRO-542 The risk or severity of adverse effects can be increased when PRO-542 is combined with Lebrikizumab.
TNX-901 The risk or severity of adverse effects can be increased when TNX-901 is combined with Lebrikizumab.
Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Lebrikizumab.
RI 624 The risk or severity of adverse effects can be increased when RI 624 is combined with Lebrikizumab.
Stamulumab The risk or severity of adverse effects can be increased when MYO-029 is combined with Lebrikizumab.
CT-011 The risk or severity of adverse effects can be increased when CT-011 is combined with Lebrikizumab.
Leronlimab The risk or severity of adverse effects can be increased when Leronlimab is combined with Lebrikizumab.
Glembatumumab vedotin The risk or severity of adverse effects can be increased when Glembatumumab vedotin is combined with Lebrikizumab.
Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Lebrikizumab.
IPH 2101 The risk or severity of adverse effects can be increased when IPH 2101 is combined with Lebrikizumab.
TB-402 The risk or severity of adverse effects can be increased when TB-402 is combined with Lebrikizumab.
Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Lebrikizumab.
IMC-1C11 The risk or severity of adverse effects can be increased when IMC-1C11 is combined with Lebrikizumab.
Eldelumab The risk or severity of adverse effects can be increased when Eldelumab is combined with Lebrikizumab.
Lumiliximab The risk or severity of adverse effects can be increased when Lumiliximab is combined with Lebrikizumab.

Target Protein

Interleukin-13 IL13

Referensi & Sumber

Artikel (PubMed)
  • PMID: 29353026
    Simpson EL, Flohr C, Eichenfield LF, Bieber T, Sofen H, Taieb A, Owen R, Putnam W, Castro M, DeBusk K, Lin CY, Voulgari A, Yen K, Omachi TA: Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018 May;78(5):863-871.e11. doi: 10.1016/j.jaad.2018.01.017. Epub 2018 Jan 17.
  • PMID: 37401345
    Prajapati S, Fardos M, Desai AD, Feldman SR: The role of lebrikizumab in the treatment of atopic dermatitis in the adult population. Immunotherapy. 2023 Sep;15(13):981-991. doi: 10.2217/imt-2023-0066. Epub 2023 Jul 4.

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