Active Ingredient: Ciclosporin
Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
2.5 - 5 mg per kg of body weight
From 1.25 To 2.5 mg per kg of body weight 2 time(s) per day every day
When using ciclosporin in any of the established non-transplantation indications, the following general rules should be adhered to:
Before initiation of treatment a reliable baseline level of renal function should be established by at least two measurements. The estimated glomerular filtration rate (eGFR) by the MDRD formula can be used for estimation of renal function in adults and an appropriate formula should be used to assess eGFR in paediatric patients. Since ciclosporin can impair renal function, it is necessary to assess renal function frequently. If eGFR decreases by more than 25% below baseline at more than one measurement, the dosage of ciclosporin should be reduced by 25 to 50%. If the eGFR decrease from baseline exceeds 35%, further reduction of the dose of ciclosporin should be considered. These recommendations apply even if the patient’s values still lie within the laboratory’s normal range. If dose reduction is not successful in improving eGFR within one month, ciclosporin treatment should be discontinued.
Regular monitoring of blood pressure is required.
The determination of bilirubin and parameters that assess hepatic function are required prior to starting therapy and close monitoring during treatment is recommended. Determinations of serum lipids, potassium, magnesium and uric acid are advisable before treatment and periodically during treatment.
Occasional monitoring of ciclosporin blood levels may be relevant in non-transplant indications, e.g. when ciclosporin is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
The normal route of administration is by mouth. If the concentrate for solution for infusion is used, careful consideration should be given to administering an adequate intravenous dose that corresponds to the oral dose. Consultation with a physician with experience of use of ciclosporin is recommended.
Except in patients with sight-threatening endogenous uveitis and in children with nephrotic syndrome, the total daily dose must never exceed 5 mg/kg.
For maintenance treatment the lowest effective and well tolerated dosage should be determined individually.
In patients in whom within a given time no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with ciclosporin should be discontinued.
Neoral treatment should be initiated by physicians with experience in the diagnosis and treatment of psoriasis. Due to the variability of this condition, treatment must be individualised. For inducing remission, the recommended initial dose is 2.5 mg/kg/day orally given in 2 divided doses. If there is no improvement after 1 month, the daily dose may be gradually increased, but should not exceed 5 mg/kg. Treatment should be discontinued in patients in whom sufficient response of psoriatic lesions cannot be achieved within 6 weeks on 5 mg/kg/day, or in whom the effective dose is not compatible with the established safety guidelines.
Initial doses of 5 mg/kg/day are justified in patients whose condition requires rapid improvement. Once satisfactory response is achieved, ciclosporin may be discontinued and subsequent relapse managed with re-introduction of ciclosporin at the previous effective dose. In some patients, continuous maintenance therapy may be necessary.
For maintenance treatment, doses have to be titrated individually to the lowest effective level, and should not exceed 5 mg/kg/day.
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