Calcort (deflazacort)

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Calcort (deflazacort)

How to buy Calcort: You can order Calcort (deflazacort) 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 Sanofi
Disease Several conditions involving inflammation in the body
Indication Asthma; Arthritis; Allergies; Tumours; Immune system suppression; Skin, kidney, heart, digestive system, eyes or blood conditions; Duchenne muscular dystrophy (off-label)
Mode of Action Glucocorticoid
Approval Status MHRA approved (UK); BfArM approved (DE)
CAS Number 853426-35-4
HS Code 30021098
Strength 6 mg

Who is deflazacort for?

Calcort (deflazacort) is indicated for the treatment of patients with several conditions. Among these are:
  • inflammation including asthma, arthritis, and allergies
  • skin, kidney, heart, digestive system, eyes or blood conditions
  • tumours
Calcort (deflazacort) can also be used to suppress the immune system in transplant operations.
Moreover, deflazacort has been frequently used for the treatment of Duchenne muscular dystrophy (DMD) [5][6][7][8][12][13] and is referred to as the most commonly prescribed corticosteroid for DMD in Canada [1].

Recommended dose

Complete information about Calcort (deflazacort). dosage and administration can be found here [2].
Consult your treating doctor for personalised dosing.

What is deflazacort and how does it work?

Calcort (deflazacort) is a glucocorticoid used to treat several conditions involving inflammation of the body [2].
Glucocorticoids are a class of corticosteroids which occur naturally in the body and help to maintain health and wellbeing. Boosting your body with extra corticosteroid is an effective way to treat various illnesses involving inflammation of the body. Deflazacort works by reducing this inflammation. It also stops reactions known as autoimmune reactions. These reactions occur when your immune system attacks the body itself causing damage [2].

What is deflazacort’s approval status?


Unlike most of our products, deflazacort isn’t a new medicine and is marketed under several different names across the world [3][9]. Among several other countries, it is approved under the name Calcort in the UK [10] and Germany [11].
Besides its many uses in the treatment of inflammations and autoimmune diseases [2], the benefits of deflazacort on DMD emerged from several studies [1][5][6][7][8][12][15]. Corticosteroids are the standard therapy to delay DMD progression [12] with some reports indicating less weight gain in patients using deflazacort than those using other corticosteroids, like prednisolone [1][5][7][8][12][13][15].
In February 2017 deflazacort received FDA approval for the treatment of DMD under the name Emflaza, manufactured by Marathon Pharmaceuticals [4][14]. This approval was based on a study of 196 boys, ranging from 5 to 15 years old [15]. The study lasted 52 weeks and compared deflazacort at two different dosages (0.9 or 1.2 mg/ kg/ day) with prednisone (another corticosteroid commonly used to treat DMD) and placebo. After 12 weeks of treatment, both deflazacort (at both dosages) and prednisone showed superior changes in average muscles strength scores: deflazacort produced a score of 0.15 with the dosage of 0.9 mg/ kg/ d (95 % CI 0.01—0.28) [16] and a score of 0.26 with the of dosage 1.2 mg/ kg/ d (95 % CI 0.12—0.40); prednisone produced a score of 0.27 (95 % CI 0.13—0.41); placebo produced a score of -0.1 (95 % CI -0.23—0.03) [15]. Moreover, both medications were better than placebo on several timed motor function tests (i.e., time to stand from supine, time to climb four stairs and time to walk or run 30 feet) [15].From week 12 to week 52 the group treated with deflazacort with the dosage of 0.9 mg/ kg/ d showed better results in changes of average muscle strength score (0.17, 95 % CI 0.03—0.31) than the group treated with prednisone (-0.12, 95 % CI -0.26—0.03) [15].
References
[1] L.C. Mc Adam, et al. The Canadian experience with long term deflazacort treatment in Duchenne muscular dystrophy. Acta Myol. 2012 May; 31(1):16–20.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3440807/
[2] Package leaflet: Calcort (deflazacort), Sanofi S.p.a., 20/12/2016.
https://www.medicines.org.uk/emc/PIL.21423.latest.pdf
[3] Wikipedia. Deflazacort, (last update: 17/03/2017), cited on 16/03/2017.
https://en.wikipedia.org/wiki/Deflazacort#cite_note-Centralx-11
[4] FDA News Release: FDA approves drug to treat Duchenne muscular dystrophy, 09/02/2017.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540945.htm
[5] A. Markham and H.M. Bryson. Deflazacort. A review of its pharmacological properties and therapeutic efficacy. H.M. Drugs. 1995 Aug.; 50(2):317–333.
http://europepmc.org/abstract/MED/8521761
[6] B.L. Wong, et al. Long-term outcome of interdisciplinary management of patients with Duchenne muscular dystrophy receiving daily glucocorticoid treatment. J. of Pediatrics. 2017 Mar; 182:296–303.
https://www.ncbi.nlm.nih.gov/pubmed/28043681
[7] A.Y. Manzur, et al. Glucocorticoid corticosteroids for Duchenne muscular dystrophy. Cochrane Database Syst. Rev. 2008 Jan; 23(1):CD003725.
https://www.ncbi.nlm.nih.gov/pubmed/18254031
[8] A. Ciccione. Deflazacort Improves Muscle Strength, Functional Outcomes in Duchenne Muscular Dystrophy. Neurology Advisor. 01/09/2016.
http://www.neurologyadvisor.com/neuromuscular-disorders/deflazacort-improves-muscle-strength-functional-outcomes-in-duchenne-muscular-dystrophy/article/520254/2/
[9] Drugs.com. Deflazacort, cited on 16/03/2017.
https://www.drugs.com/international/deflazacort.html
[10] eMC. Calcort 6mg Tablets, 11/06/2008 (last update: 10/03/2017), cited on 16/03/2017.
https://www.medicines.org.uk/emc/medicine/20915
[11] DIMDI – Recherche-Einstieg – AMIS Öffentlicher Teil. Searched word: deflazacort. Cited on 16/03/2017.
http://www.dimdi.de/dynamic/de/db/recherche/index.htm
[12] M.S. Falzarano, et al. Duchenne Muscular Dystrophy: From Diagnosis to Therapy. Molecules. 2015 Oct; 20(10):18168–84.
https://www.ncbi.nlm.nih.gov/pubmed/26457695
[13] K. Bushby, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and pharmacological and psychosocial management. The Lancet Neurology. 2009 Nov; 9(1):77–93.
http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(09)70271-6/fulltext
[14] Marathon Pharmaceuticals News Release: FDA approves Emflaza (deflazacort) tablets and oral suspension for the treatment of Duchenne muscular dystrophy in patients 5 years and older, 09/02/2017.
http://marathonpharma.com/news/2017/02/emflaza-deflazacort-just-fda-approved/
[15] R.C. Griggs, et al. Efficacy and safety of deflazacort vs prednisone and placebo for Duchenne muscular dystrophy. Neurology. 2016 Nov; 87(20):2123–2131.
http://www.neurology.org/content/87/20/2123.long
[16] Summary of Product Characteristics [FDA]: Emflaza (deflazacort), Marathon Pharmaceuticals LLC, Feb 2017.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf








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