Vumerity® (diroximel fumarate)

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® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of patients with relapsing remitting MS and is available through the Pharmaceutical Benefits Scheme (PBS). Your neurologist will need to obtain an authority to prescribe the medication for you.

For details of the criteria required to receive a prescription for Vumerity® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/pbs/home. You will need to click on the red Authority Required (STREAMLINED) link.

If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.

Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website.

If you are not eligible for Vumerity® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.