Tecfidera

Tecfidera

dimethyl fumarate

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Dimethyl fumarate
Indications/Uses
Adults w/ relapsing remitting multiple sclerosis.
Dosage/Direction for Use
Initially 120 mg bid. Dose should be increased to maintenance dose of 240 mg bid after 7 days. Dose reduction: 120 mg bid. W/in 1 mth, recommended maintenance dose should be resumed.
Administration
Should be taken with food.
Contraindications
Special Precautions
Hypersensitivity or anaphylactoid reactions. Assess renal function (eg, creatinine, BUN & urinalysis) prior to treatment initiation, after 3 & 6 mth of treatment, & every 6-12 mth thereafter; serum aminotransferases (eg, ALT & AST) & total bilirubin levels prior to treatment initiation & during treatment. Severe prolonged lymphopenia may occur. Patients w/ preexisting low lymphocyte counts. Perform CBC including lymphocytes prior to treatment & every 3 mth thereafter. Consider treatment interruption if lymphocyte counts <0.5 x 109/L persists for >6 mth. Baseline MRI should be available before initiating treatment. Withhold use at the 1st sign or symptom of progressive multifocal leukoencephalopathy (PML) & perform appropriate diagnostic evaluation. Prior treatment w/ immunosuppressive or immunomodulating therapies. Patients w/ severe active GI disease. Consider suspending treatment if infections, herpes zoster occur. Monitor for signs & symptoms of herpes zoster. Gradually start Tecfidera treatment. Discontinue treatment if Fanconi syndrome occurs. Severe renal or hepatic impairment. Pregnancy & lactation. Childn & adolescents 10-18 yr.
Adverse Reactions
Flushing; diarrhoea, nausea, upper abdominal pain, abdominal pain; ketones measured in urine. Gastroenteritis; lymphopenia; leucopenia; burning sensation; hot flush; vomiting, dyspepsia, gastritis, GI disorder; increased AST &/or ALT; pruritus, rash, erythema, proteinuria; feeling hot; present albumin in urine decreased WBCs.
Drug Interactions
Concomitant use w/ anti-neoplastic or immunosuppressive therapies, fumaric acid derivatives (topical or systemic), acetylsalicylic acid. Live attenuated vaccines. May increase renal adverse reactions w/ nephrotoxic drugs eg, aminoglycosides, diuretics, NSAIDs or lithium. May lead to increased frequency of GI adverse reactions w/ large quantities of strong alcohol.
MIMS Class
ATC Classification
L04AX07 - dimethyl fumarate ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
Tecfidera gastro-resistant hard cap 240 mg
Packing/Price
14's
Form
Tecfidera gastro-resistant hard cap 120 mg
Packing/Price
14's
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