Ciclosporin (Rheumatology)

Source: UK SPC (eMC) for Capimune 100 mg soft capsules, §4.2 (https://www.medicines.org.uk/emc/product/695/smpc). The dose ranges given for oral administration are intended to serve as guidelines only. Up to 12 weeks of therapy may be required to achieve full effectiveness. For maintenance treatment the dose has to be titrated individually to the lowest effective level according to tolerability. Ciclosporin can be given in combination with low-dose corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs). PRESCRIBER: should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive therapy and/or organ transplantation. MONITORING REQUIRED IN NON-TRANSPLANT INDICATIONS: before initiation, establish a reliable baseline of renal function from at least two measurements (eGFR by the MDRD formula in adults). Assess renal function frequently - if eGFR decreases by more than 25% below baseline at more than one measurement, reduce the dose by 25 to 50%; if the eGFR decrease from baseline exceeds 35%, consider further dose reduction; these recommendations apply even if the patient's values still lie within the laboratory's normal range, and if dose reduction is not successful in improving eGFR within one month, treatment should be discontinued. Regular monitoring of blood pressure is required. Bilirubin and parameters that assess hepatic function are required prior to starting therapy with close monitoring during treatment. Serum lipids, potassium, magnesium and uric acid should be determined before treatment and periodically during treatment. Occasional monitoring of ciclosporin blood levels may be relevant in non-transplant indications, e.g. with substances that interfere with ciclosporin pharmacokinetics or in the event of unusual clinical response. STOPPING RULE: in patients in whom no adequate response is achieved within the specified time, or in whom the effective dose is not compatible with the established safety guidelines, treatment should be discontinued. HEPATIC IMPAIRMENT: an approximate 2- to 3-fold increase in ciclosporin exposure may be observed; dose reduction may be necessary in severe liver impairment to maintain blood levels within the recommended target range, and ciclosporin blood levels should be monitored until stable. ELDERLY (65 years and above): experience is limited; in rheumatoid arthritis clinical trials with oral ciclosporin, patients aged 65 or older were more likely to develop systolic hypertension on therapy and more likely to show serum creatinine rises of 50% or more above baseline after 3 to 4 months. Dose selection should be cautious, usually starting at the low end of the dosing range. FORMULATION SWITCHING: the switch from one oral ciclosporin formulation to another should be made under physician supervision. PAEDIATRIC (no per-kg rheumatology dose is stated for children): the SPC states 'Use of Capimune in children for non-transplantation indications other than nephrotic syndrome cannot be recommended', so no paediatric rheumatology dose exists in this label; clinical studies have included children from 1 year of age and in several studies paediatric patients required and tolerated higher doses per kg body weight than adults. Verify any under-18 use against a children's formulary. OTHER NON-TRANSPLANT REGIMENS ON THE SAME LABEL, for context only - endogenous uveitis: initially 5 mg/kg/day orally in 2 divided doses, increased in refractory cases to 7 mg/kg/day for a limited period. Nephrotic syndrome: adults 5 mg/kg/day, children 6 mg/kg/day, in 2 divided oral doses; initial dose not to exceed 2.5 mg/kg/day if renal function is impaired. Psoriasis: initial 2.5 mg/kg/day in two divided doses, not exceeding 5 mg/kg. Atopic dermatitis: 2.5 to 5 mg/kg/day in 2 divided oral doses. US CROSS-CHECK NOT USABLE: the openFDA label fetched into this bundle is VEVYE (Harrow Eye), a cyclosporine 0.1% OPHTHALMIC solution dosed as one drop twice a day in each eye - a different product, route and indication. Do not carry any of its content onto this page.