Peringatan Keamanan

No significant toxicities related to the administration of lanadelumab have been reported.A38679

Studies regarding the carcinogenic potential or overdosage effect have not been performed. Published literature supports bradykinin, which is elevated in HAE, as a pro-tumorigenic molecule. However, the malignancy risk in humans from an antibody that inhibits plasma kallikrein activity, such as lanadelumab-flyo, which lowers bradykinin levels, is currently unknown.L45108 There are no available data on lanadelumab use in pregnant women to inform of any drug-associated risks. Monoclonal antibodies such as lanadelumab-flyo are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. An enhanced pre-and postnatal development (ePPND) study conducted in pregnant monkeys at doses resulting in exposures of up to 33 times the exposure achieved (on an AUC basis) at the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus.L45108

Lanadelumab

DB14597

biotech approved investigational

Deskripsi

Lanadelumab, also known as DX-2930, is a human IgG1 monoclonal antibody designed for subcutaneous self-injection.L4538 It is a fully human immunoglobulin, k-light-chain made in recombinant Chinese Hamster Ovary cells.L4537 It has been granted priority review, breakthrough therapy, and orphan drug designations for rare diseases based on the results of clinical trials.A38676 Lanadelumab was approved for use in patients with hereditary angioedema by the FDA in August 2018,L4537 followed by Health Canada in October 2018L49226 and the EMA in November 2018.L49221

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) Lanadelumab has a half-life of approximately 2 weeks after subcutaneous administration.[L45108]
Volume Distribusi The apparent volume of distribution of lanadelumab is approximately 14 - 16 L depending on the dose administered.[L45108]
Klirens (Clearance) The apparent clearance of lanadelumab ranges from 0.667 to 0.809 L/day depending on the administered dose.[L45108]

Absorpsi

Drug levels of lanadelumab are dose-dependent and the maximum plasma concentration increases correspondingly with increasing dosage. The Cmax and AUC ranged from 3800 - 45000 ng/ml and 64000 - 762000 ng.day/ml, respectively, across a dosing range of 30 to 400 mg. A sustained quantifiable drug concentration was observed through day 120.A38677 The bioavailability of lanadelumab is approximately 66% with a time to reach peak drug concentration of approximately 7 days.L45108,A38679

Metabolisme

As with other therapeutic proteins, the degradation of lanadelumab likely occurs via catabolism to smaller peptides and amino acids.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

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

Target Protein

Plasma kallikrein KLKB1

Referensi & Sumber

Artikel (PubMed)
  • PMID: 29300693
    Kaplon H, Reichert JM: Antibodies to watch in 2018. MAbs. 2018 Feb/Mar;10(2):183-203. doi: 10.1080/19420862.2018.1415671. Epub 2018 Jan 16.
  • PMID: 28225674
    Banerji A, Busse P, Shennak M, Lumry W, Davis-Lorton M, Wedner HJ, Jacobs J, Baker J, Bernstein JA, Lockey R, Li HH, Craig T, Cicardi M, Riedl M, Al-Ghazawi A, Soo C, Iarrobino R, Sexton DJ, TenHoor C, Kenniston JA, Faucette R, Still JG, Kushner H, Mensah R, Stevens C, Biedenkapp JC, Chyung Y, Adelman B: Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis. N Engl J Med. 2017 Feb 23;376(8):717-728. doi: 10.1056/NEJMoa1605767.
  • PMID: 27960628
    Reichert JM: Antibodies to watch in 2017. MAbs. 2017 Feb/Mar;9(2):167-181. doi: 10.1080/19420862.2016.1269580. Epub 2016 Dec 14.
  • PMID: 24980392
    Chyung Y, Vince B, Iarrobino R, Sexton D, Kenniston J, Faucette R, TenHoor C, Stolz LE, Stevens C, Biedenkapp J, Adelman B: A phase 1 study investigating DX-2930 in healthy subjects. Ann Allergy Asthma Immunol. 2014 Oct;113(4):460-6.e2. doi: 10.1016/j.anai.2014.05.028. Epub 2014 Jun 26.

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