Safety Alerts & Recalls

What does this mean?

If you are taking ciclosporin, become familiar with the brand name of ciclosporin that you take and what the capsules, tablets or solution looks like. Be aware that substitution with any other oral brand or formulation of ciclosporin is not recommended without careful therapeutic monitoring. Check each of your prescriptions to make sure it looks similar to what you received before. If you notice any differences, be sure to notify your pharmacist.

If switching to a different brand or formulation of ciclosporin is unavoidable, your doctor should closely monitor you for side effects, ciclosporin drug blood concentrations, serum creatinine levels, blood pressure, and transplant function.

If you have concerns about this alert or your ciclosporin prescription, please follow up with your doctor or pharmacist.

Ciclosporin Must Be Prescribed and Dispensed By Brand Name

In the December 2009 Drug Safety Update, the MHRA advises that Ciclosporin must be prescribed and dispensed by brand name. Ciclosporin is indicated for the prevention and treatment of transplant rejection, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome. Ciclosporin is a critical-dose drug where dosing is very specific for an individual patient and is based on monitoring blood levels and side effects.

The established ciclosporine brands are Neoral and Sandimmun. Recently, a number of new versions of ciclosporin-containing products have been granted marketing licenses in the UK, including the brand Deximune. However, because of the critical-dose nature of the drug, even small differences in how the medicine dissolves, absorbs, and releases in the blood stream could affect ciclosporin blood levels in patients stabilised on a specific brand or formulation. This difference could potentially lead to organ rejection or side effects. Therefore, all prescribing and dispensing of ciclosporin should be by brand name to avoid accidental switching.

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Source: MHRA
Publication Date: 2009-12-09
Last Updated: 2010-11-08

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