FURATEC

What it is

FURATEC contains dimethyl fumarate in delayed release capsule formulations of 120 mg and 240 mg strength. The 120 mg capsules are white to off-white enteric coated mini tablets in size 1 hard gelatin capsules with a green cap and white body, while the 240 mg capsules contain the same formulation in size 0 hard gelatin capsules with a green cap and green body.

Approved indications

— Relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Dosing overview

The starting dose for FURATEC is 120 mg twice a day orally, increasing after 7 days 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, with the recommended dose of 240 mg twice a day resuming within 1 month. FURATEC can be taken with or without food, though taking it with food may improve tolerability for patients experiencing gastrointestinal or flushing side effects. The capsule or its contents should not be crushed, divided or dissolved as the enteric coating of the microtablets prevents irritant effects on the gut.

Key safety warnings

Dimethyl fumarate may decrease lymphocyte counts, with mean lymphocyte counts decreasing by approximately 30% during the first year of treatment and then remaining stable, and WBC counts less than 3.0 × 10⁹/L and lymphocyte counts less than 0.5 × 10⁹/L reported in 6 to 7% of subjects. A recent complete blood count including lymphocytes is recommended prior to initiating treatment, after 6 months of treatment, and every 6 to 12 months thereafter. Progressive multifocal leukoencephalopathy has occurred in the setting of lymphopenia in patients with multiple sclerosis treated with FURATEC, predominantly in the setting of prolonged moderate to severe lymphopenia, and is an opportunistic viral infection of the brain that may lead to death or severe disability. At the first sign or symptom suggestive of progressive multifocal leukoencephalopathy, FURATEC should be withheld and an appropriate diagnostic evaluation performed. Cases of anaphylaxis have been reported following FURATEC administration, with these reactions generally occurring after the first dose but potentially at any time during treatment and being serious and life threatening, and patients should be instructed to discontinue FURATEC and seek immediate medical care if they experience signs or symptoms of anaphylaxis. Serious cases of herpes zoster have occurred with FURATEC, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis and herpes zoster meningomyelitis, with these events potentially occurring at any time during treatment. Serious gastrointestinal reactions, including perforation, ulceration, haemorrhage and obstruction, some with fatal outcomes, have been reported in the post-marketing setting with fumaric acid esters including dimethyl fumarate, with the majority of these events occurring within 6 months of treatment initiation.

Contraindications

FURATEC is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any excipients in the product.

Regulatory history

FURATEC dimethyl fumarate 120 mg and 240 mg delayed release capsules were first listed on the ARTG on 14 July 2021 under licence category RE.