Treatment:

Tecfidera® (dimethyl fumarate)

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Tecfidera® is an oral treatment for relapsing remitting MS, which has been shown to have anti-inflammatory and neuro-protective properties. It is thought that Tecfidera® works in MS by inhibiting immune cells and molecules and may have antioxidant properties that protect the brain and spinal cord from damage.

Clinical trials have shown it can reduce relapse rates and delay the progression of disability in people with relapsing remitting MS.

Tecfidera® is taken as an oral capsule. The recommended starting dose of Tecfidera® is 120mg, twice daily. After 7 days the dose may be increased to the recommended dose of 240mg twice daily.

Tecfidera® can be taken with or without food.

For patients who experience gastrointestinal side effects, taking the capsules during a meal may reduce these side-effects. For patients who experience flushing, taking aspirin before their Tecfidera® dose may reduce this side-effect. Discuss the dosage and duration of this with your neurologist, MS Nurse or GP.

Tecfidera® helps most people with MS, but may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.

The most common side effects of Tecfidera® are flushing, diarrhea, nausea and abdominal pain. Less common but more serious side-effects include more severe gastrointestinal side-effects, effects on the kidneys and liver, and reduced white blood cell counts.

Your neurologist will assist you to assess the risks and the expected benefit of treatment with Tecfidera® prior to starting therapy and over the course of treatment. Your health professional can provide comprehensive information on the use of Tecfidera®, including precautions and side effects.

There is limited data on the effects of Tecfidera® in pregnant women. The limited number of pregnant women and women of child-bearing age who have taken Tecfidera® reported no increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus.

If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

There is no published experience with dimethyl fumarate during breastfeeding. Although the drug is not contraindicated during breastfeeding, some experts recommend its avoidance. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

Tecfidera® 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 Tecfidera® treatment through the PBS, please visit the official PBS website at:
http://www.pbs.gov.au/medicine/item/2896K-2943X – 120mg http://www.pbs.gov.au/medicine/item/2966D – 240mg

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 at: www.medicare.gov.au

If you are not eligible for Tecfidera® 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.

Tecfidera® (dimethyl fumarate)

Forms of MS used for:
Relapsing remitting MS
Administration route:
Oral capsule
Dosage and frequency:
One 120mg capsule twice daily, increasing to one 240mg twice daily
Storage:
Room temperature, below 30°C
TGA approval date:
July 2013
Available on PBS:
Yes
Manufacturer:
Biogen

General Information and Assistance

Most pharmacies do not keep Tecfidera® in stock. It is therefore important to let your pharmacist know a few days before you need the medication so that they can order it in for you.

For more information

Speak to your neurologist about what treatment best suits your individual circumstances.

MS Nurses can also provide information, training and ongoing support in managing your immunotherapy.

MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects for each individual’s circumstances, should be made in careful consultation with the person’s neurologist.

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Tecfidera®