Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Inclusion Criteria:

• Patients who have completed selected ongoing or planned trials with FTY720.

Exclusion Criteria:

• Premature permanent discontinuation of a previous fingolimod study.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
• Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
• Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
• Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
• Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
• Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:

• Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

  • Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
  • Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
  • Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
  • History or presence of a third degree AV block
  • Proven history of sick sinus syndrome or sino-atrial heart block
  • Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

• Any of the following pulmonary conditions during the previous fingolimod study:

  • Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
  • Active tuberculosis
• Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Other protocol-defined inclusion/exclusion criteria may apply.