Sandimmun Neoral and associated names

Sandimmun and Sandimmun Neoral are immunosuppressive medicines (medicines that reduce the activity of the immune system, the body's natural defences). Both medicines contain the active substance ciclosporin. However, while Sandimmun is an oil-based formulation of ciclosporin, Sandimmun Neoral is a microemulsified formulation, which allows for a more uniform absorption of ciclosporin by the body.

Sandimmun and Sandimmun Neoral are used in patients who have had a transplant, to prevent rejection (when the immune system attacks the transplanted organ) and to treat or prevent graft-versus-host disease (when the immune system of the transplanted organ attacks the patient's tissues). They are also used to treat autoimmune diseases. An autoimmune disease is a disease which is caused by the body's own defence system attacking normal tissue.

The active substance in Sandimmun and Sandimmun Neoral, ciclosporin, acts on some special cells in the immune system called T-cells that are responsible for attacking transplanted organs or, in auto-immune diseases, normal tissue.
Sandimmun and Sandimmun Neoral are available as capsules (10, 25, 50 and 100 mg) and oral solution (100 mg/ml). Sandimmun is also available as a concentrate for solution for infusion (50 mg/ml). Both medicines are available in the EU under other trade names: Immunosporin, Neoral, Neoral – Sandimmun, Sandimmun Optoral and Sandimmune.

The companies that market these medicines are Novartis group of companies and associated companies.

Sandimmun and Sandimmun Neoral are authorised in the EU via national procedures. This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.

Sandimmun and Sandimmun Neoral were identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).

On 15 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Sandimmun and Sandimmun Neoral in the EU.

The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.

The areas harmonised include:

4.1 Therapeutic indications

The CHMP agreed that Sandimmun and Sandimmun Neoral should be used in the following indications, which were already approved in several but not all EU Member States:

• Solid organ transplantation (for the prevention and treatment of graft rejection);
• Bone marrow transplantation (for the prevention of graft rejection and prevention or treatment of graft-versus-host disease).

In addition, the capsules and oral solutions may also be used to treat the following autoimmune diseases:

• Endogenous uveitis (inflammation of the uvea, the middle layer of the eye);
• Nephrotic syndrome (a kidney disease);
• Severe rheumatoid arthritis (a disease causing damage and inflammation in the joints);
• Severe psoriasis (a disease causing red, scaly patches on the skin);
• Severe atopic dermatitis (eczema, an itchy red rash of the skin).

The CHMP did not recommend use in aplastic anaemia (a blood disorder in which the bone marrow doesn't make enough new blood cells), which was approved in only one Member State.

4.2 Posology and method of administration

The CHMP agreed on specific dose ranges for the various indications, which should serve as guidelines only, and recommended that these medicines should be given in two divided doses equally distributed throughout the day.

Sandimmun and Sandimmun Neoral should only be prescribed by, or in close collaboration with, a doctor experienced in the diseases that these medicines are used to treat.

Information on how to switch between different ciclosporin medicines was also included in the product information of these medicines.

4.3 Contra-indications

The CHMP agreed that Sandimmun and Sandimmun Neoral should not be used in patients who are hypersensitive (allergic) to the active substance. They should also not be given in combination with a herbal medicine called St John's wort (used to treat depression) nor with medicines whose blood levels may be increased by ciclosporin and lead to serious side effects, such as dabigatran etexilate (used to prevent the formation of blood clots after surgery) or bosentan and aliskiren (used to treat high blood pressure).

Other changes

The Committee also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.5 (interactions with other medicines) and 4.6 (use in pregnancy and breast feeding). The package leaflet was amended accordingly.