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| == '''What is Dimethyl Fumarate?''' == | | {{Drugbox |
| | | Verifiedfields = changed |
| | | verifiedrevid = 477241703 |
| | | image = Dimethyl fumarate.svg |
| | | width = 200 |
| | | image2 = Dimethyl fumarate ball-and-stick model.png |
| | | width2 = 200 |
| | | tradename = Tecfidera |
| | | Drugs.com = |
| | | MedlinePlus = a613049 |
| | | pregnancy_AU = B1 |
| | | pregnancy_US = C |
| | | legal_AU = S4 |
| | | legal_CA = Rx-only |
| | | legal_UK = POM |
| | | legal_US = Rx-only |
| | | routes_of_administration = Oral |
| | | bioavailability = 2-3% |
| | | protein_bound = 27-40% |
| | | metabolism = Hydrolysis, then [[Cytochrome P450|CYP]]-independent metabolism |
| | | elimination_half-life = 0.5-1 hour |
| | | excretion = CO2 (60%), renal (16%), fecal (1%) |
| | | CAS_number = 624-49-7 |
| | | ATC_prefix = L04 |
| | | ATC_suffix = AX07 |
| | | PubChem = 637568 |
| | | DrugBank = DB08908 |
| | | ChemSpiderID = 553679 |
| | | UNII = K848JZ4886 |
| | | KEGG = D03630 |
| | | ChEBI = 31408 |
| | | ChEMBL = 2103876 |
| | | IUPAC_name = Dimethyl (E)-butenedioate |
| | | chemical_formula = C6H8O4 |
| | | molar_mass = 144.13 g/mol |
| | }} |
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| * Dimethyl Fumarate ('''TECFIDERA''') is a prescription medicine used to treat relapsing forms of [[multiple sclerosis]] (MS).
| | '''Dimethyl fumarate''' (DMF) is a medication primarily used to treat [[multiple sclerosis]] (MS) and [[psoriasis]]. It is marketed under the brand name '''Tecfidera''' among others. DMF is an oral medication that modulates the immune system and has anti-inflammatory properties. |
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| [[File:Dimethyl fumarate.png|thumb]]
| | ==Medical Uses== |
| [[File:Dimethyl fumarate Structural Formulae.png|thumb]] | | Dimethyl fumarate is used in the treatment of [[relapsing-remitting multiple sclerosis]] (RRMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is also used for the treatment of moderate to severe [[psoriasis]], a chronic autoimmune skin condition. |
| [[File:Dimethyl fumarate3D.png|thumb]] | |
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| | ==Mechanism of Action== |
| title='''{{PAGENAME}}'''
| | The exact mechanism by which dimethyl fumarate exerts its effects in multiple sclerosis is not fully understood. However, it is believed to involve the activation of the [[Nrf2]] pathway, which leads to a reduction in oxidative stress and inflammation. This pathway is thought to protect against neurodegeneration and promote cellular homeostasis. |
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| | ==Side Effects== |
| | Common side effects of dimethyl fumarate include [[flushing]], [[gastrointestinal]] events such as [[diarrhea]], [[nausea]], and [[abdominal pain]]. Serious side effects may include [[progressive multifocal leukoencephalopathy]] (PML), a rare brain infection, and [[lymphopenia]], a decrease in white blood cells. |
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| == '''What are the uses of this medicine?''' == | | ==Pharmacokinetics== |
| | Dimethyl fumarate is rapidly absorbed after oral administration and is extensively metabolized by [[esterases]] to its active metabolite, monomethyl fumarate (MMF). The drug has a short half-life of approximately 0.5 to 1 hour and is primarily excreted as carbon dioxide through exhalation, with minor renal and fecal excretion. |
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| * This medicine is used to treat [[Relapsing-remitting multiple sclerosis|relapsing]] forms of multiple sclerosis (MS), to include clinically isolated syndrome, [[Relapsing-remitting MS|relapsing-remitting]] disease, and active secondary progressive disease, in adults.
| | ==History== |
| | Dimethyl fumarate was approved for medical use in the United States in 2013 and in the European Union in 2014. It was initially developed as a treatment for psoriasis before being repurposed for multiple sclerosis. |
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| == '''How does this medicine work?''' == | | ==See Also== |
| | * [[Multiple sclerosis treatment]] |
| | * [[Psoriasis treatment]] |
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| <youtube>
| | ==References== |
| title='''{{PAGENAME}}'''
| | <references/> |
| movie_url=http://www.youtube.com/v/v=FLgP4JuVUVY
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| * The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in [[multiple sclerosis]] is unknown.
| | ==External Links== |
| * DMF and the metabolite, monomethyl fumarate (MMF), have been '''shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway''' in vitro and in vivo in animals and humans.
| | * [https://www.drugs.com/tecfidera.html Tecfidera on Drugs.com] |
| * The Nrf2 pathway is '''involved in the cellular response to oxidative stress'''.
| | * [https://www.nationalmssociety.org/Treating-MS/Medications/Tecfidera National MS Society - Tecfidera] |
| * MMF has been identified as a nicotinic acid receptor agonist in vitro.
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| == '''Who Should Not Use this medicine ?''' ==
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| This medicine cannot be used in patientsː
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| * with known [[hypersensitivity]] to dimethyl fumarate or to any of the excipients of TECFIDERA
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| == '''What drug interactions can this medicine cause?''' ==
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| * No formal drug interaction studies have been conducted with TECFIDERA.
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| == '''Is this medicine FDA approved?''' ==
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| * FDA approved this drug in the year of 2013.
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| == '''How should this medicine be used?''' == | |
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| * Obtain a [[complete blood cell count]] (CBC) including [[lymphocyte]] count before initiation of therapy. | |
| * Obtain serum [[aminotransferase]], [[alkaline phosphatase]], and total [[bilirubin]] levels prior to treatment with TECFIDERA.
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| '''Recommended Dosage:'''
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| * The starting dose for TECFIDERA is '''120 mg twice a day '''orally.
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| * After 7 days, the dose should be''' increased to the maintenance dose of 240 mg twice a day''' orally.
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| * Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose.
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| * Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed.
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| '''Administration'''
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| * Take TECFIDERA exactly as your doctor tells you to take it
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| * The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
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| * The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day
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| * TECFIDERA can be taken with or without food
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| * Swallow TECFIDERA whole. Do not crush, chew, or sprinkle capsule contents on food.
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| * Protect TECFIDERA from light. You can do this by storing the capsules in their original container.
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| * If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.
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| == '''What are the dosage forms and brand names of this medicine?''' ==
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| This medicine is available in fallowing doasage form:
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| * '''As Delayed-release capsules:''' 120 mg and 240 mg
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| This medicine is available in fallowing brand namesː
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| *'''TECFIDERA'''
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| =='''What side effects can this medication cause?'''==
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| The most common side effects of this medicine include:
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| * [[flushing]], redness, itching, or rash | |
| * nausea, vomiting, diarrhea, stomach pain, or indigestion
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| * Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing.
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| TECFIDERA may cause serious side effects including:
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| * allergic reaction
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| * [[Progressive multifocal leukoencephalopathy]] (PML)
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| * decreases in your white blood cell count
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| * liver problems
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| * [[herpes zoster]] infections ([[shingles]])
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| * other serious infections
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| ==''' What special precautions should I follow?''' ==
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| * TECFIDERA can cause [[anaphylaxis]] and [[angioedema]] after the first dose or at any time during treatment. Discontinue and do not restart TECFIDERA if these occur.
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| * [[Progressive multifocal leukoencephalopathy (PML)|Progressive multifocal leukoencephalopathy]] (PML) has occurred in patients with MS treated with TECFIDERA. Withhold TECFIDERA at the first sign or symptom suggestive of PML.
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| * Serious cases of [[herpes zoster]] have occurred with TECFIDERA, including [[disseminated]] herpes zoster, herpes zoster [[ophthalmicus]], herpes zoster [[meningoencephalitis]], and herpes zoster [[meningomyelitis]]. Consider withholding TECFIDERA in cases of serious infection until the infection has resolved.
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| * TECFIDERA may decrease [[lymphocyte]] counts. Obtain a CBC including lymphocyte count before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter. Consider interruption of TECFIDERA if lymphocyte counts <0.5 x 109/L persist for more than six months.
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| * Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA. Obtain serum [[aminotransferase]], [[alkaline phosphatase]], and total [[bilirubin]] levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.
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| == '''What to do in case of emergency/overdose?''' ==
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| '''Management for overdosage:'''
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| * In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.
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| * There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote.
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| == '''Can this medicine be used in pregnancy?''' ==
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| * There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women.
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| * There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com.
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| =='''Can this medicine be used in children?'''==
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| * Safety and effectiveness in pediatric patients have not been established.
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| == '''What are the active and inactive ingredients in this medicine?''' ==
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| * '''Active ingredient:''' dimethyl fumarate
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| * '''Inactive ingredients:''' microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. Capsule Shell: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.
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| == '''Who manufactures and distributes this medicine?''' ==
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| * '''Manufactured for:''' Biogen Inc., Cambridge
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| == '''What should I know about storage and disposal of this medication?''' ==
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| * Store at 15°C to 30°C (59 to 86°F).
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| * Protect the capsules from light.
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| * Store in original container.
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| {{Demyelinating diseases of CNS}}
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| {{Immunosuppressants}}
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| {{Portal bar | Medicine}}
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| {{Authority control}}
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| {{DEFAULTSORT:Dimethyl Fumarate}} | | {{DEFAULTSORT:Dimethyl Fumarate}} |
| [[Category:Fungicides]] | | [[Category:Multiple sclerosis drugs]] |
| [[Category:Fumarate esters]] | | [[Category:Psoriasis treatments]] |
| [[Category:Methyl esters]] | | [[Category:Immunosuppressants]] |
| [[Category:Orphan drugs]] | | [[Category:Esters]] |
| | [[Category:Carboxylate esters]] |
Dimethyl fumarate (DMF) is a medication primarily used to treat multiple sclerosis (MS) and psoriasis. It is marketed under the brand name Tecfidera among others. DMF is an oral medication that modulates the immune system and has anti-inflammatory properties.
Medical Uses
Dimethyl fumarate is used in the treatment of relapsing-remitting multiple sclerosis (RRMS), a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms. It is also used for the treatment of moderate to severe psoriasis, a chronic autoimmune skin condition.
Mechanism of Action
The exact mechanism by which dimethyl fumarate exerts its effects in multiple sclerosis is not fully understood. However, it is believed to involve the activation of the Nrf2 pathway, which leads to a reduction in oxidative stress and inflammation. This pathway is thought to protect against neurodegeneration and promote cellular homeostasis.
Side Effects
Common side effects of dimethyl fumarate include flushing, gastrointestinal events such as diarrhea, nausea, and abdominal pain. Serious side effects may include progressive multifocal leukoencephalopathy (PML), a rare brain infection, and lymphopenia, a decrease in white blood cells.
Pharmacokinetics
Dimethyl fumarate is rapidly absorbed after oral administration and is extensively metabolized by esterases to its active metabolite, monomethyl fumarate (MMF). The drug has a short half-life of approximately 0.5 to 1 hour and is primarily excreted as carbon dioxide through exhalation, with minor renal and fecal excretion.
History
Dimethyl fumarate was approved for medical use in the United States in 2013 and in the European Union in 2014. It was initially developed as a treatment for psoriasis before being repurposed for multiple sclerosis.
See Also
References
<references/>
External Links
