Tecfidera Drug Interactions

Tecfidera has not been studied in combination with anti-neoplastic or immunosuppressive therapies. and caution should, therefore, be used during concomitant administration.
In multiple sclerosis clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection. Vaccination during treatment with Tecfidera has not been studied. It is not known whether treatment with Tecfidera might reduce the effectiveness of some vaccines. Live vaccines might carry an increased risk of clinical infection and should not be given to patients treated with Tecfidera unless, in exceptional cases, this potential risk is considered to be outweighed by the risk to the individual of not vaccinating.
During treatment with Tecfidera, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided.
In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system. Potential drug interaction risks were not identified from in vitro CYP-inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate).
Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.
Administration of 325 mg (or equivalent) non-enteric coated acetylsalicylic acid, 30 minutes prior to Tecfidera, over 4 days of dosing, did not alter the pharmacokinetic profile of Tecfidera and reduced the occurrence and severity of flushing in a healthy volunteer study. However, long term use of acetylsalicylic acid is not recommended for the management of flushing. Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera. (See Dosage & Administration, Precautions and Adverse Reactions).
Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, NSAIDs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria) in patients taking Tecfidera (see Adverse Reactions).
Consumption of moderate amounts of alcohol did not alter exposure to Tecfidera and was not associated with an increase in adverse reactions. Consumption of large quantities of undiluted strong alcoholic drinks (more than 30% alcohol by volume) may lead to increased dissolution rates of Tecfidera and, therefore, may increase the frequency of gastrointestinal adverse reactions.
In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives. In vivo interaction studies have not been performed with oral contraceptives. Even though an interaction is not expected, non-hormonal contraceptive measures should be considered with Tecfidera (see Use in Pregnancy & Lactation).
Paediatric Population: Interaction studies have only been performed in adults.