Dimethyl Fumarate Brand Name– Tecfidera
What is Dimethyl Fumarate
Dimethyl fumarate is indicated for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Dimethyl fumarate appears to have neuroprotective and anti-inflammatory properties; these actions can help delay disability and disease progression.
In the pivotal pre-approval trial, dimethyl fumarate 240 mg twice daily led to significant reductions in the annualized relapse rate over 2 years (0.17) as compared with placebo (0.36).
The trial also showed a 38% decrease in risk of disability progression with treatment (p=0.005) and a significant improvement in quality of life scores as early as week 24.
Similar results were found in another phase 3 trial: the annualized relapse rate over 2 years was significantly lower with dimethyl fumarate vs. placebo
Indications
- multiple sclerosis
For the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Side Effects
- abdominal pain
- anaphylactoid reactions
- angioedema
- diarrhea
- dyspepsia
- elevated hepatic enzymes
- eosinophilia
- erythema
- flushing
- flushing
- infection
- leukoencephalopathy
- leukopenia
- lymphopenia
- lymphopenia
- nausea
- progressive multifocal leukoencephalopathy
- proteinuria
- pruritus
- rash
- vomiting
Monitoring Parameters
- CBC with differential
- LFTs
- serum bilirubin
Contraindications
- breast-feeding
- hepatic disease
- hepatotoxicity
- immunosuppression
- pregnancy
- progressive multifocal leukoencephalopathy
Interactions
- Diroximel Fumarate
- Ocrelizumab