Adult Dosing

Relasping forms of multiple sclerosis

• Start 120 mg PO bid initially x 7 days
• Maintainance after 7 days: Increase to 240 mg PO bid

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relasping forms of multiple sclerosis

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Therapy may lead to decrease in lymphocyte counts. In clinical trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment, and then remained stable
• Before initiating treatment with dimethyl fumarate a complete blood count should be carried out and therafter CBC count is recommended annually and as clinically indicated
• Withheld therapy in patients with serious infections untill the infections resolve
• Treatment with dimethyl fumarate may cause flushing reactions such as warmth, redness, itching, and/or burning sensation
• Treatment with dimethyl fumarate caused transient increase in mean eosinophil counts during the first 2 months of therapy

Pregnancy Category:C

Breastfeeding: It is unknown if this drug is excreted in human milk. Manufacturer advises mothers to refrain from breastfeeding unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

• HEMA: Lymphopenia
• GI: Abdominal pain, diarrhea, nausea, vomiting, dyspepsia
• CV: Flushing
• DERM: Pruritus, rash, erythema
• LAB TESTS: Albumin urine present, aspartate aminotransferase increased

• Methyl ester of fumaric acid; elicits immunomodulatory effects and activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, a transcription factor encoded by the NFE2L2 gene
• Metabolism: Metabolized rapidly by presystemic hydrolysis by esterases in GI tract, blood, and tissues; converted to active metabolite monomethyl fumarate (MMF)
• Excretion: 60% by exhalation of CO2; Renal (16 %); Feces (1 %)
• Half-life (monomethyl fumarate): Approximately 1 hr

US Trade Name(s)

• Tecfidera

US Availability

Tecfidera

• CAPS: 120, 140 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Dermatologic

Dermatologic Topical Agents

Astringents