Deflazacort 1mg tablets
Requires a prescription from a doctor or prescriber
Deflazacort, also known as Emflaza, is a corticosteroid prodrug used as an agent to manage Duchenne Muscular Dystrophy (DMD).
Safety information for pregnancy and breastfeeding
Pregnancy
Use in lactation
Corticosteroids, when administered systemically, are excreted in the breastmilk.
Breastfeeding
Use in lactation
Corticosteroids, when administered systemically, are excreted in the breastmilk.
Always consult your doctor or midwife before taking any medicine during pregnancy or while breastfeeding. Source: DrugBank (CC BY-NC 4.0).
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Deflazacort
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Interactive Drug Analysis Profiles for all medicines
Report a side effect
Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Deflazacort
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Learn about EU pharmacovigilance and safety monitoring
EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
2 branded products available
WHO defined daily dose (DDD)
15 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Deflazacort
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(2)
Vamorolone for treating Duchenne muscular dystrophy in people 4 years and over (TA1031)
Ataluren for treating Duchenne muscular dystrophy with a nonsense mutation in the dystrophin gene (HST22)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
1.1 to 1.9 h
Mechanism
Deflazacort is a corticosteroid prodrug with an active metabolite, 21-deflazacor…
Food interactions
3 warnings
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
1-2 hours
[A179464]…
Half-life
1.1 to 1.9 h
Protein binding
40%
[A18759]
Volume of distribution
84 L
[A18725]
Metabolism
21-OH
[A18725][A179464][L6703]…
Elimination
70%
[A18725]…
Clearance
27 L/h
[A18725]
The…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Duchenne Muscular Dystrophy is an inherited disorder resulting from mutations of the dystrophin gene, which is important for muscle function. This disease can cause serious muscle weakness and progressive breathing and cardiovascular disability, severely impacting patient quality of life and survival.[A179446][A179449][L6697] This disease usually manifests by muscle weakness in early childhood followed by loss of the ability to walk (ambulation) as early as age 7.[A179449]
Deflazacort delays the onset of muscle related complications resulting from DMD[A179455], prolonging the lives of children diagnosed with this disease and exerting less harmful effects on the bone health and weight than other steroid medications.[A179452][A25340]
[L52135]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1141 interactions
A note on altered endocrine function and immunosuppression
Deflazacort, as a steroid prodrug used over a long-term period, can cause hormone imbalance leading to diseases such as Cushing's Syndrome and hypothalamic-pituitary-adrenal axis suppression. It can also predispose to infection, as it promotes immunosuppression.
[A179464]
It is important to monitor for hormonal imbalance and infection and provide necessary treatment if they occur.
[L52135]
Mutagenicity/carcinogenicity
Mutagenicity assays were negative in various laboratory and in vivo assays performed on rats.
[L6703]
Chronic use in mice for 2 years in one study resulted in a higher rate of osteoma and osteosarcomas in mice receiving 0.06, 0.12, 0.25, 0.50, or 1.0 mg/kg of deflazacort daily.
[L52135]
Use in pregnancy
There are no sufficient data to support the administration of deflazacort during pregnancy. Corticosteroid drugs such as deflazacort should only be used during pregnancy only if the benefits of therapy outweigh the potential risks.
[L6703]
Use in lactation
Corticosteroids, when administered systemically, are excreted in the breastmilk.
Exposure may lead to disturbances in bone development and growth and endocrine disturbances in the exposed infant.
[L6703]
Effects on muscle strength
At age 16, individuals treated with long-term deflazacort had 63 ± 4% score in muscle strength compared to a mean muscle strength score of 31 ± 3% for control patients[A179455]. Significant improvements in climbing stairs and rising from a supine position were also seen in patients taking deflazacort.[A179455]
Effects on ambulation
Ambulation was significantly higher by 12 years of age and 18 years of age in patients taking deflazacort when compared with the control group. The control group showed a mean loss of ambulation of 2 years sooner than with deflazacort treatment.[A179458]
Effects on cardiac function
Mean left ventricular ejection fraction (a measure of cardiac function) was higher in patients treated with deflazacort over the long term. Preservation of cardiac function was demonstrated by a mean difference in ejection fraction of about 7%, favoring study groups taking deflazacort over control groups.[A179458]
Effects on spinal alignment
Children treated with deflazacort also significantly lowered the rate and severity of scoliosis and eliminated the need for scoliosis surgery after long-term treatment.[A179455][A179458]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A179464]
One pharmacokinetic study determined an AUC (area under the curve) of 280 ng/ml x h.
[A18725]
The bioavailability of both the oral suspension and tablet are similar.
[L52135]
In clinical studies, coadministration of deflazacort crushed with food or applesauce did not affect absorption or bioavailability.
[L52135]
[A18759]
[A18725]
[A18725][A179464][L6703]
21-deflazacort is then further metabolized by CYP3A4 to inactive metabolite products.
[A179473]
Deflazacort 21-OH metabolism is extensive. The metabolite of deflazacort-21-OH is deflazacort 6-beta-OH.
[A179473][L6703]
[A18725]
The remainder of the dose (about 30%) is excreted in the feces.
[A18725]
Elimination is almost completed by 24 hours post-dose.
[A179467]
21-deflazacort makes up about 18% of the eliminated drug in the urine.
[L52135]
[A18725]
The clearance of corticosteroids is enhanced in hypothyroid patients and increased in patients with hyperthyroidism. Dosing adjustments may be considered according to thyroid status.
[L52135]
A study of corticosteroid clearance was performed in patients with a creatinine clearance of 15 mL/min or less, and determined that the active metabolite of deflazacort, 21-deflazacort was similar to that in patients with normal renal clearance.
[L52135]
Proteins and enzymes this drug interacts with in the body
PMID:27120390 PMID:37478846
Has a dual mode of action: as a transcription factor that binds to glucocorticoid response elements (GRE), both for nuclear and mitochondrial DNA, and as a modulator of other transcription factors .
PMID:28139699
Affects inflammatory responses, cellular proliferation and differentiation in target tissues. Involved in chromatin remodeling .
PMID:9590696
Plays a role in rapid mRNA degradation by binding to the 5' UTR of target mRNAs and interacting with PNRC2 in a ligand-dependent manner which recruits the RNA helicase UPF1 and the mRNA-decapping enzyme DCP1A, leading to RNA decay .
PMID:25775514
Could act as a coactivator for STAT5-dependent transcription upon growth hormone (GH) stimulation and could reveal an essential role of hepatic GR in the control of body growth (By similarity)
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC H02AB13
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Deflazacort
Additional database identifiers
ChemSpider
164861
ZINC
ZINC000004212809
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7978
GenAtlas
NR3C1
GeneCards
NR3C1
GenBank Gene Database
X03225
GenBank Protein Database
31680
Guide to Pharmacology
625
UniProt Accession
GCR_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2638
GenAtlas
CYP3A5
GeneCards
CYP3A5
GenBank Gene Database
J04813
GenBank Protein Database
181346
Guide to Pharmacology
1338
UniProt Accession
CP3A5_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: