TECFIDERA

What it is

TECFIDERA is dimethyl fumarate (DMF) formulated as modified release capsules. TECFIDERA is formulated as enteric coated microtablets enclosed within hard gelatin capsules, containing the active ingredient dimethyl fumarate. Each TECFIDERA capsule contains 120 mg or 240 mg DMF.

Approved indications

— Reducing the frequency of relapses and delaying the progression of disability in patients with relapsing multiple sclerosis.

Dosing overview

The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, increase to the recommended dose of 240 mg twice a day orally. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal side effects. Within 1 month, the recommended dose of 240 mg twice a day orally should be resumed. TECFIDERA can be taken with or without food. For those patients who may experience gastrointestinal or flushing side effects, taking TECFIDERA with food may improve tolerability.

Key safety warnings

TECFIDERA may decrease lymphocyte counts. In the MS placebo-controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable. Prior to initiating treatment with TECFIDERA, a recent complete blood count (CBC) including lymphocytes (within 6 months) is recommended. A CBC, including lymphocytes, is also recommended after 6 months of treatment and every 6 to 12 months thereafter, and as clinically indicated. Progressive multifocal leukoencephalopathy (PML) has occurred in the setting of lymphopenia (<0.91 x 10⁹/L) in patients with multiple sclerosis treated with TECFIDERA. These PML cases have occurred predominantly in the setting of prolonged moderate to severe lymphopenia. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation. Cases of anaphylaxis have been reported following TECFIDERA administration. These reactions generally occurred after the first dose, but may occur at any time during treatment, and may be serious and life threatening. Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on TECFIDERA for signs and symptoms of herpes zoster. Serious gastrointestinal reactions, including perforation, ulceration, haemorrhage, and obstruction, some with fatal outcomes, have been reported in the post-marketing setting with the use of fumaric acid esters, including TECFIDERA. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation.

Contraindications

TECFIDERA is contraindicated in patients with known hypersensitivity to DMF or any excipients in this product.

PBS listing

TECFIDERA was recommended by the PBAC in November 2014 for relapsing-remitting multiple sclerosis on the basis of acceptable clinical effectiveness and cost-effectiveness compared to existing oral disease-modifying therapies. In November 2019, PBAC recommended amending existing listings to Authority Required (STREAMLINED).

Regulatory history

TECFIDERA dimethyl fumarate 120 mg and 240 mg modified release capsules were first listed on the ARTG on 11 July 2013. The TGA approved TECFIDERA on 3 July 2013 for the treatment of relapsing multiple sclerosis. The PBAC recommended listing in November 2014. In July 2016, the PBAC recommended a change to increase the maximum quantity of 120 mg dimethyl fumarate tablets from one to two packs for both the initial and continuing dose titration periods.