VUMERITY

What it is

VUMERITY contains diroximel fumarate 231 mg as the active ingredient, supplied as enteric coated minitablets enclosed within white hypromellose capsules. VUMERITY and TECFIDERA are metabolised to monomethyl fumarate upon oral administration. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— VUMERITY is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Dosing overview

The starting dose for VUMERITY is 231 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dose reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dose, and within 4 weeks, the recommended dose of 462 mg twice a day should be resumed. VUMERITY should be swallowed whole and intact and should not be crushed or chewed. VUMERITY can be taken with or without food.

Key safety warnings

Due to the risk of serious, possibly fatal infection, patients who develop lymphopenia as a result of treatment with VUMERITY require close monitoring. Prior to initiating treatment with VUMERITY, 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. PML has been reported in patients treated with dimethyl fumarate. PML is an opportunistic infection caused by John Cunningham virus (JCV), which may be fatal or result in severe disability. PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of lymphopenia. At the first sign or symptom suggestive of PML, VUMERITY should be withheld and appropriate diagnostic evaluations, including determination of JCV DNA in cerebrospinal fluid (CSF) by quantitative polymerase chain reaction (PCR) methodology, need to be performed. In dimethyl fumarate pivotal clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions. These adverse reactions were not life-threatening but led to hospitalisation. Prescribers and patients should be alert to this possibility in the event of severe flushing reactions with VUMERITY. 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. Patients should be instructed to discontinue VUMERITY and seek immediate medical care if they experience signs or symptoms of anaphylaxis. 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 VUMERITY, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation.

Contraindications

VUMERITY is contraindicated in patients with known hypersensitivity to diroximel fumarate, any excipients in this product, or other fumaric acid derivatives. VUMERITY is contraindicated in suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML).

PBS listing

PBS listing information for VUMERITY is not included in the provided source documents.

Regulatory history

VUMERITY (diroximel fumarate 231 mg enteric capsules) was first listed on the ARTG on 21 March 2022. The AusPAR approval date was 18 March 2022. In March 2022, PBAC recommended VUMERITY for relapsing-remitting multiple sclerosis. The TGA's evaluation relied on bridging efficacy and safety data from Tecfidera (dimethyl fumarate), as VUMERITY metabolises to the same active moiety, monomethyl fumarate, and bioequivalence was demonstrated. The risks associated with VUMERITY are expected to be similar to those reported for dimethyl fumarate.