Dimethyl Fumarate

DEA Class;  Rx

Common Brand Names; Tecfidera, BG-12

• Flushing (40%)
• Abdominal pain (18%)
• Diarrhea (14%)
• Nausea (12%)
• Vomiting (9%)
• Pruritus (8%)
• Rash (8%)
• Albumin in urine (6%)
• Erythema (5%)
• Dyspepsia (5%)
• Increased AST (4%)
• Lymphopenia (2%)
• Transient eosinophilia
• Hepatobiliary disorders including liver function abnormalities (elevations in transaminases greater than or equal to 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN)
• Rhinorrhea
• Alopecia
• Herpes zoster and other serious opportunistic infections

May cause lymphopenia; obtain a CBC including lymphocyte count before initiating therapy, after 6 months, and q6-12 months thereafter, and as clinically indicated; consider treatment interruption with lymphocyte counts <0.5 x 10^9/L persisting for >6 months; continue to obtain lymphocyte counts until their recovery if drug is discontinued or interrupted due to lymphopenia; consider withholding treatment from patients with serious infections until resolution; decisions about whether or not to restart dimethyl fumarate should be individualized based on clinical circumstances

Flushing (eg, warmth, redness, itching, and/or burning sensation) may occur; flushing symptoms generally may happen soon after initiating treatment and improve or resolve over time; in the majority of patients experiencing flushing, it is mild or moderate in severity

Progressive multifocal leukoencephalopathy (PML) resulting in death, in the postmarketing setting have occurred; withhold therapy at first sign or symptom suggestive of PML; perform appropriate diagnostic evaluation; cases have occurred predominantly in patients with lymphocyte counts <0.8×10^9/L persisting for more than 6 months; role of lymphopenia in PML cases uncertain

Do not restart therapy if anaphylaxis or angioedema occur

There are no adequate data on developmental risk associated with use in pregnant women; in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses

There are no data on presence of DMF or MMF in human milk; effects on breastfed infant and on milk production are unknown