Edaravone generic (edaravone)

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Edaravone generic (edaravone)

How to buy edaravone: You can order edaravone via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Daiichi Sankyo, Meiji Seika, Pfizer
Disease Cerebral infarction
Indication Cerebral infarction
Mode of Action Radical scavenger
Approval Status PMDA approved (JAP)
Strength 30 mg / 20 mL (vials); 30 mg / 100 mL (bags)

Who is edaravone for?

Edaravone is indicated for patients affected by neurological symptoms, disability in daily living, and functional impairment accompanying the acute phase of cerebral infarction [1][2].
The active ingredient edaravone is approved in Japan and USA also for the treatment of some patients affected by Amyotrophic Lateral Sclerosis (ALS) [3][4]. The EMA granted orphan designation to edaravone for the treatment of ALS [5].

Recommended dose

Complete information about edaravone dosage and administration for the treatment of cerebral infarction can be found here: [1][2][9][10][11][12].
  • 30 mg of edaravone administered intravenously over 30 minutes twice a day in the morning and the evening
  • Administration of this product should be initiated within 24 hours after the onset of the disease, and the duration of administration should be within 14 days.
  • Consider terminating administration in a shorter period depending on symptoms.
Edaravone is the active ingredient of two other drugs, Radicut and Radicava, which are indicated for the treatment of ALS. The standard dosage of Radicut and Radicava for adult patients with ALS is [3][4]:
  • 60 mg of edaravone (2 vials/bags) administered intravenously over 60 minutes once a day.
  • First cycle: daily dosing for 14 days followed by a 14-day drug-free period (28 vials/bags).
  • Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods (20 vials/bags).
Edaravone is supplied in two formats:
  • Single-dose infusion bags containing 30 mg / 100 mL clear, colorless, sterile solution. The infusion bags are ready for use. No dilution is required [2].
  • Single-dose vials containing 30 mg / 20 mL clear, colorless, sterile solution. Before the infusion, it should be diluted with an appropriate volume of physiological saline [1].
Administer carefully to patients with renal dysfunction and dehydration, infectious diseases, liver dysfunction, heart disease, advanced consciousness disorder and to elderly people [1][2].

What is edaravone and how does it work?

Edaravone is a radical scavenger used to treat patients with acute cerebral infarction [1][2]. Edaravone is used also for the treatment of patients with ALS [3][4].
Free radicals such as hydroxyl radical (-OH) play a major causative role in the development of cerebral vascular disorder resulting from ischaemia. During ischaemia or ischaemic reperfusion, the production of free radicals increases which leads to cell membrane injury and ultimately to cerebral dysfunction. By eliminating free radicals, it is effective to suppress cell membrane lipid peroxidation [1][2].

Is edaravone approved?

Edaravone was approved by the PMDA (JAP) for the treatment of acute cerebral infarction [1][2][9][10][11][12].
The active ingredient edaravone is the main component of a drug produced by Mitsubishi Tanabe named Radicut in Japan and Radicava in USA. Under these names, edaravone is approved for the treatment of patients affected by ALS. The results of the clinical studies on patients affected by ALS can be found here: [6][7][8].
References
[1] Summary of Product Characteristics [PMDA]: Edaravone Pfizer (edaravone) - Injection, Pfizer, July 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/671450_1190401A1139_1_08
[2] Summary of Product Characteristics [PMDA]: Edaravone Pfizer (edaravone) - Injection Bag, Pfizer, July 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/671450_1190401G1190_1_03
[3] Summary of Product Characteristics [PMDA]: Radicut (edaravone), Mitsubishi Tanabe Pharma Corporation, June 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400315_1190401A10
[4] Summary of Product Characteristics [FDA]: Radicava (edaravone), MT Pharma America Inc., May 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf
[5] EMA. Public summary of opinion on orphan designation. 23/02/2015.
http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2015/02/WC500183226.pdf
[6] Summary of Product Characteristics [FDA]: Radicava (edaravone), MT Pharma America Inc., May 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209176lbl.pdf
[7] Abe K., et al. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec; 15(7–8):610–7
https://www.ncbi.nlm.nih.gov/pubmed/25286015
[8] Yoshino H. and Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (Phase II study). Amyotroph Lateral Scler. 2006 Dec.; 7(4):241–5.
https://www.ncbi.nlm.nih.gov/pubmed/17127563
[9] Summary of Product Characteristics [PMDA]: Edaravone Daiichi Sankyo Esfa Co. (edaravone) - Injection, Daiichi Sankyo Esfa Co., June 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430773_1190401A1031_1_06
[10] Summary of Product Characteristics [PMDA]: Edaravone Daiichi Sankyo Esfa Co. (edaravone) - Infusion Bag, Daiichi Sankyo Esfa Co., June 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430773_1190401G1034_1_05
[11] Summary of Product Characteristics [PMDA]: Edaravone MeijiSeika Pharma Co. (edaravone) - Infusion Bag, MeijiSeika Pharma Co., July 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/780009_1190401G1093_1_06
[12] Summary of Product Characteristics [PMDA]: Edaravone MeijiSeika Pharma Co. (edaravone) - Infusion, MeijiSeika Pharma Co., July 2015.
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/780009_1190401A1147_1_06

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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