Voclosporin (Calcineurin Inhibitor — Lupus Nephritis)

Treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of lupus nephritis. Lupkynis should be used in combination with mycophenolate mofetil. Physicians should evaluate the efficacy of treatment at a time point of at least 24 weeks and make an appropriate risk-benefit analysis for continuation of therapy. MISSED DOSE: take as soon as possible within 4 hours after missing the dose; beyond the 4-hour time frame, take the next regular dose at the usual scheduled time. The next dose should not be doubled. DOSE ADJUSTMENT BASED ON eGFR (SPC Table 1) - establish a baseline eGFR before starting, assess every two weeks for the first month and every four weeks thereafter. Adjustments are required where eGFR is confirmed reduced (two consecutive assessments within 48 hours) and below 60 mL/min/1.73 m2. Confirmed decrease from baseline of 30% or more: stop voclosporin, restart on eGFR recovery at 7.9 mg (1 capsule) twice daily and increase as tolerated. Greater than 20% and less than 30%: reduce by 7.9 mg (1 capsule) twice daily, retest within two weeks and, if not recovered, reduce by a further 7.9 mg twice daily. 20% or less: maintain current dose and monitor. If eGFR remains at or above 60 mL/min/1.73 m2 no dose modification is required. For patients whose dose was reduced, consider increasing by 7.9 mg twice a day for each eGFR measurement that is at least 80% of baseline. MODERATE CYP3A4 INHIBITORS (e.g. verapamil, fluconazole, diltiazem): daily dose must be reduced to 15.8 mg in the morning and 7.9 mg in the evening. HEPATIC IMPAIRMENT: mild and moderate (Child-Pugh A and B) - recommended starting dose 15.8 mg twice daily; severe (Child-Pugh C) not assessed and not recommended. RENAL IMPAIRMENT: limited data for baseline eGFR 30 to less than 45 mL/min/1.73 m2 - use only if benefit outweighs risk, at a starting dose of 23.7 mg twice daily. Not studied in eGFR below 30 mL/min/1.73 m2 and not recommended unless benefit outweighs risk; if used, recommended starting dose 15.8 mg twice daily. ELDERLY: data are limited in lupus nephritis patients over 65 years and there are no data over 75 years; not recommended in patients over 75 years of age. PAEDIATRIC: safety and efficacy in children and adolescents aged 5 to 18 years have not yet been established (no data available); there is no relevant use below 5 years of age in lupus nephritis.