TRAZENT

What it is

TRAZENT contains dimethyl fumarate and is available as delayed release capsules containing either 120 mg or 240 mg of the active ingredient.

Approved indications

— Reduction of the frequency of relapses in patients with relapsing multiple sclerosis. — Delaying progression of disability in patients with relapsing multiple sclerosis.

Dosing overview

The starting dose for TRAZENT is 120 mg twice daily by mouth. After 7 days, this should be increased to the recommended dose of 240 mg twice daily by mouth. Temporary dose reduction to 120 mg twice daily may reduce flushing and gastrointestinal side effects, and the recommended dose of 240 mg twice daily should be resumed within 1 month. TRAZENT can be taken with or without food, although taking it with food may improve tolerability in patients who experience 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

TRAZENT may decrease lymphocyte counts, with mean lymphocyte counts decreasing by approximately 30% during the first year of treatment and then remaining stable. Due to the risk of serious, possibly fatal infection, patients who develop lymphopenia as a result of treatment with TRAZENT require close monitoring. Progressive multifocal leukoencephalopathy (PML) has occurred in the setting of lymphopenia in patients with multiple sclerosis treated with TRAZENT, predominantly in the setting of prolonged moderate to severe lymphopenia. PML is an opportunistic viral infection of the brain that may lead to death or severe disability, and its symptoms may be similar to a multiple sclerosis relapse. Typical symptoms include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation. Cases of anaphylaxis have been reported following dimethyl fumarate administration, generally occurring after the first dose but potentially at any time during treatment. Patients experiencing signs or symptoms of anaphylaxis should discontinue TRAZENT and seek immediate medical care. Serious cases of herpes zoster have occurred with TRAZENT, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis and herpes zoster meningomyelitis, which may occur at any time during treatment. Patients should be monitored for signs and symptoms of herpes zoster and appropriate treatment administered if it occurs. Serious gastrointestinal reactions, including perforation, ulceration, haemorrhage, and obstruction, some with fatal outcomes, have been reported with fumaric acid esters including dimethyl fumarate, with the majority of events occurring within 6 months of treatment initiation. The safety of live attenuated vaccines during treatment with TRAZENT has not been evaluated in clinical trials, and live vaccines are not recommended during treatment due to the potential risk of clinical infection.

Contraindications

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

PBS listing

No information regarding PBS listing has been provided in the source documents.

Regulatory history

TRAZENT dimethyl fumarate 120 mg enteric coated capsule was first listed on the ARTG on 28 June 2022, and the 240 mg formulation was also first listed on the same date.