The active ingredient of VUMERITY® is diroximel fumarate. It is used for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to slow down the progression of physical disability in people with relapsing forms of MS and decrease the number of relapses (flare ups).
In MS, the immune system mistakenly attacks the protective layer (myelin) around the nerve cells. This causes inflammation and damage which stops the nervous system working properly.
In RRMS, VUMERITY® has been shown to result in fewer relapses, less disease activity in the brain and less progression of disability.
Diroximel fumarate has biological activity similar to Tecfidera (dimethyl fumarate). In the body, both drugs are converted to monomethyl fumarate which reduces inflammation caused by MS activity and may protect nerve cells from damage.
VUMERITY® is taken as a tablet twice daily.
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. Within 4 weeks, the recommended dose of 462 mg twice a day should be resumed. Discontinuation of Vumerity should be considered for patients unable to tolerate return to the maintenance dose.
VUMERITY® helps most people with MS, but it may have unwanted side effects in some people. All medicines can have side effects. Tell your doctor if you notice anything that is making you feel unwell.
In healthy clinical trial participants, the most common side effects were flushing, dizziness, and constipation. In clinical studies, diroximel fumarate caused fewer gastrointestinal side effects than Tecfidera.
Other side effects include colds, diarrhoea and chest infections.
Do not use VUMERITY® if you are pregnant unless you have discussed this with your doctor. This is because VUMERITY® could harm your unborn baby. Your doctor will discuss the risks and benefits of taking it if you are pregnant. If you are able to get pregnant, you should use reliable contraception. Check with your doctor if you intend to become pregnant. There is no information on the use of VUMERITY® during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether VUMERITY® passes into breastmilk. Your doctor will discuss the risks and benefits of taking it if you are breastfeeding.
VUMERITY® was approved by the Therapeutic Goods Administration (TGA) in March 2022.
It was recommended for listing on the Pharmaceutical Benefits Scheme (PBS) by the Pharmaceutical Benefits Advisory Committee (PBAC) at its meeting in March 2022.
It has yet to be approved for listing on the PBS by the Australian Government.
In Australia, VUMERITY® is supplied by:
Biogen Australia Pty Ltd
Level 4/2 Banfield Rd
Macquarie Park NSW 2113
Medical Information: 02 8875 3900