Treatment:

Gilenya® (fingolimod)

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Gilenya® belongs to a class of medications called sphingosine 1-phosphate (s1P) receptor modulators. The active ingredient in Gilenya® is fingolimod. Gilenya® acts on certain types of white blood cells called lymphocytes. In MS, these small lymphocyte cells play a role in destroying myelin, the protective sheath that surrounds the nerve fibres and helps with the efficient flow of nerve signals or messages to and from the brain and various parts of the body. Gilenya® helps prevent lymphocytes leaving the lymph nodes. This lowers the number of lymphocytes circulating in the blood and reaching the central nervous system, which in turn reduces damage to the nerve cells in the brain and spinal cord.

Gilenya® has been shown in clinical trials to have significant beneficial effect in adults and children of 10 years of age and above, with relapsing-remitting MS (RRMS) by reducing relapses, delaying disability progression and showing a lower rate of brain volume loss on magnetic resonance imaging (MRI).

Gilenya® is taken orally in capsule form, once a day. The dosage is 0.5mg for adults and children over 40kg in weight; for children weighing 40kg or under the dose is 0.25mg.

The first dose of Gilenya® is given in a doctors’ office or clinic, where the person is observed for six hours to monitor heart rate and any adverse side effects. Following this initial dose, one capsule is taken each day. If Gilenya® therapy is discontinued for more than two weeks and reintroduced, the same process used for initial dosing is applied.

Similarly, for a child moving from the 0.25mg dose (40kg and under) to the 0.5mg dose (once above 40kg), the six-hour observation is repeated for their first 0.5mg dose.

Gilenya 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 Gilenya® include headache, influenza, infection, diarrhea, back pain, abnormal liver enzyme levels and coughing.

Less common but potentially serious side effects included slow heart rate (when starting treatment), breathing difficulties, skin cancers, and increased risk of infection. Particularly in the first few months of treatment, there is also the potential for a rare side effect called macula oedema, which is swelling of the macula in the eye. Your neurologist will advise on what to look for and any tests that may be required to detect macula oedema, depending on your medical history.

To reduce the risk of people developing any one of these serious side effects and to ensure that they are identified as quickly as possible if experienced, there are strict safety protocols in place. These include a number of screening tests before you are prescribed Gilenya® and an observation period after your initial capsule. Your neurologist or clinic staff can provide you with more information about this process.

A condition called Progressive Multifocal Leukoencephalopathy (PML) has been associated with taking Gilenya®, although the rate of PML is very low. PML is a life threatening brain infection caused by the John Cunningham (JC) virus which manifests in people whose immune system has been suppressed. PML has also been associated with other immunosuppressive medications for MS. Your MS healthcare team will carefully monitor you for this condition.

Your neurologist, MS Nurse, GP or pharmacist can provide comprehensive information on the safe use of Gilenya®, precautions and a complete list of common and more serious side effects.

The prescription of Gilenya® is based on strict criteria and the medical opinion and close supervision of a treating neurologist. Please discuss with your neurologist, MS Nurse or GP whether Gilenya® is the right treatment for you.

Gilenya® has not been tested in women who are pregnant, so the side effects are unknown. The use of Gilenya® is not recommended for women who are pregnant.

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

Gilenya® has not been tested in women who are breastfeeding, so this medication should be avoided during breastfeeding, especially when 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.

Both dosages of Gilenya® have been approved by the Therapeutic Goods Administration (TGA) for use in Australia. The 0.5mg capsule 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 Gilenya® treatment through the PBS, please visit the official PBS website at: http://www.pbs.gov.au/medicine/item/5262Y.

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 Gilenya® 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.

Gilenya® (fingolimod)

Forms of MS used for:
Relapsing remitting MS
Administration route:
Oral capsule
Dosage and frequency:
Adults and paediatric patients over 40 kg: one 0.5mg capsule per day Paediatric patients 40kg and under: 0.25mg capsule per day
Storage:
Room temperature, below 30°C
TGA approval date:
January 2011
Available on PBS:
Yes
Manufacturer:
Novartis

General Information and Assistance

Not all pharmacies keep Gilenya® in stock, however, most are able to order it for you if you notify them a few days before you need it.

Gilenya® comes in a box which contains 28 gel capsules. Each capsule contains either 0.5mg or 0.25mg of the active ingredient, fingolimod.

Gilenya® needs to be stored at room temperature (below 30°C) and away from moisture. Speak with your neurologist, MS Nurse or GP for more information on best storage.

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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Gilenya®