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| | | #REDIRECT[[Dimethyl fumarate]] |
| == '''What is Dimethyl Fumarate?''' ==
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| * Dimethyl Fumarate ('''TECFIDERA''') is a prescription medicine used to treat relapsing forms of [[multiple sclerosis]] (MS).
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| [[File:Dimethyl fumarate.png|thumb]]
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| [[File:Dimethyl fumarate Structural Formulae.png|thumb]] | |
| [[File:Dimethyl fumarate3D.png|thumb]]
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| <youtube>
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| title='''{{PAGENAME}}'''
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| movie_url=http://www.youtube.com/v/v=pwWtBiV8VLQ
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| embed_source_url=http://www.youtube.com/v/v=pwWtBiV8VLQ
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| &rel=1
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| wrap = yes
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| width=750
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| height=600
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| </youtube>
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| == '''What are the uses of this medicine?''' ==
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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.
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| == '''How does this medicine work?''' ==
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| <youtube>
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| title='''{{PAGENAME}}'''
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| movie_url=http://www.youtube.com/v/v=FLgP4JuVUVY
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| embed_source_url=http://www.youtube.com/v=FLgP4JuVUVY
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| &rel=1
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| wrap = yes
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| width=750
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| height=600
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| </youtube>
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| * The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in [[multiple sclerosis]] is unknown.
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| * 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.
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| * The Nrf2 pathway is '''involved in the cellular response to oxidative stress'''.
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| * 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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|
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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.
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| * 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
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| * 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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| {{coststubd}}
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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}}
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| [[Category:Fungicides]]
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| [[Category:Fumarate esters]]
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| [[Category:Methyl esters]]
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| [[Category:Orphan drugs]]
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