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Gilenya® (Fingolimod)

Gilenya is taken in capsule form (0.5mg), once a day. The first does of Gilenya is given in a clinic that has been set up and trained to administer the treatment. The person is observed for six hours to monitor heart rate and any adverse side effects. Following the initial dose, the person takes one capsule each day.

Benefits shown in clinical trials

Gilenya has been shown in clinical trials to:

  • Reduce the frequency of relapses. A two-year study comparing Gilenya to a placebo showed that it reduced relapse rates by 54 to 60 per cent.
  • Delay progression of physical disability.
  • There is also evidence it may have a direct effect in enhancing remyelination of damaged nerve cells.

 

Side Effects?

Gilenya is generally well-tolerated, although some people may experience side effects, some of them potentially quite serious.

Common side effects of Gilenya include headache, diarrhoea, back pain, cough and dizziness. These milder side effects affect around one in ten people taking Gilenya.

When you first take Gilenya it can cause your heart rate to slow down or become irregular. This may make you feel dizzy or tired.

Because of the risk of cardiac toxicity, international requirements are that the administration of the first dose of this drug requires careful cardiac monitoring for six hours.

Gilenya lowers the numbers of white blood cells in your blood. As white blood cells fight infection, you may find that you pick up illnesses and infections more easily while taking Gilenya.

Very rarely, Gilenya can cause a problem with your vision, known as macular oedema. People taking this medication will routinely require a number of other screening tests, including a specialised eye test (Ocular Coherence Tomography OCT

It is too soon to know about other possible long-term side effects from Gilenya, but people taking the drug are being monitored, which should give a better picture for the future.

Criteria

For details of the criteria you need must meet to get funded access to Gilenya® see P24-26 of the Pharmaceutical Schedule for Entry and Stopping Criteria http://www.pharmac.govt.nz/2014/11/19/SU.pdf

Special Authority must be approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC) before funding is approved. Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria.

Application details may be obtained from PHARMAC’s website http://www.pharmac.govt.nz or:

The coordinator Phone: 04 460 4990

Multiple Sclerosis Treatment Assessment Committee Facsimile: 04 916 7571

PHARMAC, PO Box 10 254, Wellington

Email: mstaccoordinator@pharmac.govt.nz

Application forms must be completed by a Neurologist or Specialist General Physician and sent to the coordinator for MSTAC and will be considered by MSTAC at the next practicable opportunity.

Notification of MSTAC’s decision will be sent to the patient, the applying clinician and the patient’s GP (if specified).