Tecfidera

Tecfidera

dimethyl fumarate

Manufacturer:

Biogen

Distributor:

The Glory Medicina
/
DKSH

Marketer:

Eisai
Concise Prescribing Info
Contents
Dimethyl fumarate
Indications/Uses
Relapsing remitting multiple sclerosis.
Dosage/Direction for Use
Initially 120 mg bd for 7 days then increased to recommended dose of 240 mg bd.
Administration
Should be taken with food: Swallow whole, do not crush/divide/dissolve/suck/chew to prevent GI irritation.
Contraindications
Special Precautions
Assess hepatic & renal function prior to treatment initiation, after 3rd & 6th mth of treatment & every 6-12 mth thereafter & as clinically indicated. Patients w/ pre-existing low lymphocyte counts. Perform CBC including lymphocytes prior to initiating treatment, after 6th mth of treatment & every 6-12 mth & as clinically indicated. Perform MRI in case of clinical suspicion of progressive multifocal leukoencephalopathy (PML). Prior treatment w/ immunosuppressive or immunomodulating therapies. Renal & hepatic impairment. Severe active GI disease. Pregnancy & lactation. Childn.
Adverse Reactions
Flushing & GI events eg, diarrhoea, nausea, abdominal pain (upper). Gastroenteritis; lymphopenia, leucopenia; burning sensation; hot flush; vomiting, dyspepsia, gastritis; pruritus, rash, erythema; proteinuria; hot feeling; ketonuria, albuminuria; increased AST & ALT, decreased WBC.
Drug Interactions
Caution when in concomitant w/ antineoplastic or immunosuppressive therapies. Increased risk of clinical infection w/ live vaccines. Avoid simultaneous use w/ fumaric acid derivatives. Increased potential of renal adverse reactions w/ nephrotoxic medicinal products eg, aminoglycosides, diuretics, NSAIDs or lithium.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AX07 - dimethyl fumarate ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Tecfidera gastro-resistant hard cap 120 mg
Packing/Price
14's
Form
Tecfidera gastro-resistant hard cap 240 mg
Packing/Price
56's
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