Peringatan Keamanan

Information regarding overdose of fremanezumab is not readily available. The most common adverse events that led to discontinuation of fremanezumab therapy were injection site reactions including erythema, induration, and pain.L11749

Fremanezumab

DB14041

biotech approved investigational

Deskripsi

Fremanezumab is a humanized monoclonal antibody targeted against human calcitonin gene-related peptide (CGRP) for the prevention of migraine headaches.L11749 It was developed by Teva Pharmaceuticals USA and approved by the FDA in September 2018.L11779 Along with other recently approved anti-CGRP therapies such as galcanezumab, erenumab, and the oral CGRP antagonist ubrogepant, fremanezumab represents an important step forward in the treatment and prevention of migraine headaches.

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean half-life recorded for fremanezumab was similar across doses for Japanese and Caucasian study subjects and was estimated to be approximately 31-39 days.[A33125,L11749]
Volume Distribusi Fremanezumab has an apparent volume of distribution of approximately 6 liters which indicates very little distribution into tissue.[L11749]
Klirens (Clearance) The apparent clearance of fremanezumab is 0.141 L/day.[L11749]

Absorpsi

Geometric mean ratios (GMRs) for Cmax for Japanese and Caucasian study subjects were 0.91, 1.04, and 1.14 for 225 mg, 675 mg, and 900 mg doses of fremanezumab A33125. GMRs for AUC (0-inf) were 0.96, 1.09, and 0.98, respectively A33125. Mean Tmax in a range of 5 to 11 days were similar across doses for both ethnicities as well A33125.

Metabolisme

Like other monoclonal antibodies, fremanezumab is expected to undergo enzymatic proteolysis into smaller peptides and amino acids.L11749

Rute Eliminasi

Monoclonal antibody agents like fremanezumab are generally not eliminated via hepatic, renal, or biliary routes.F94

Interaksi Obat

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

Target Protein

Calcitonin gene-related peptide 1 CALCA
Calcitonin gene-related peptide 2 CALCB

Referensi & Sumber

Artikel (PubMed)
  • PMID: 28409893
    Pellesi L, Guerzoni S, Pini LA: Spotlight on Anti-CGRP Monoclonal Antibodies in Migraine: The Clinical Evidence to Date. Clin Pharmacol Drug Dev. 2017 Nov;6(6):534-547. doi: 10.1002/cpdd.345. Epub 2017 Apr 14.
  • PMID: 29667896
    Cohen-Barak O, Weiss S, Rasamoelisolo M, Faulhaber N, Yeung PP, Loupe PS, Yoon E, Gandhi MD, Spiegelstein O, Aycardi E: A phase 1 study to assess the pharmacokinetics, safety, and tolerability of fremanezumab doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian healthy subjects. Cephalalgia. 2018 Jan 1:333102418771376. doi: 10.1177/0333102418771376.
  • PMID: 24867844
    Vollbracht S, Rapoport AM: New treatments for headache. Neurol Sci. 2014 May;35 Suppl 1:89-97. doi: 10.1007/s10072-014-1747-z.
  • PMID: 28948500
    Deen M, Correnti E, Kamm K, Kelderman T, Papetti L, Rubio-Beltran E, Vigneri S, Edvinsson L, Maassen Van Den Brink A: Blocking CGRP in migraine patients - a review of pros and cons. J Headache Pain. 2017 Sep 25;18(1):96. doi: 10.1186/s10194-017-0807-1.
  • PMID: 29089894
    Monteith D, Collins EC, Vandermeulen C, Van Hecken A, Raddad E, Scherer JC, Grayzel D, Schuetz TJ, de Hoon J: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the CGRP Binding Monoclonal Antibody LY2951742 (Galcanezumab) in Healthy Volunteers. Front Pharmacol. 2017 Oct 17;8:740. doi: 10.3389/fphar.2017.00740. eCollection 2017.

Contoh Produk & Brand

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