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Conventional DMARD — Calcineurin Inhibitor Pregnancy: Use only if clearly necessary — limited data; premature births reported; neonatal monitoring required

Ciclosporin (Rheumatology)

Brand names: Neoral, Sandimmun

Adult dose

Dose: 2.5–4 mg/kg/day
Route: Oral
Frequency: Twice daily (divided doses)
Max: 4 mg/kg/day
Start at 2.5 mg/kg/day in divided doses. Increase by 0.5 mg/kg/day every 4–8 weeks if inadequate response; reduce if toxicity. Take at consistent times — food effect is preparation-specific. Neoral (modified release) and Sandimmun are NOT interchangeable — specify brand.

Paediatric dose

Dose: 2.5–5 mg/kg
Route: Oral
Frequency: Twice daily
Max: 5 mg/kg/day
Juvenile idiopathic arthritis and systemic JIA with macrophage activation syndrome — under specialist guidance; higher doses may be used for MAS

Dose adjustments

Renal

Contraindicated in severe renal impairment unrelated to the inflammatory disease being treated; reduce dose by 25–50% if creatinine rises >30% above baseline

Hepatic

Reduce dose in severe hepatic impairment — ciclosporin is primarily hepatically metabolised

Paediatric weight-based calculator

Juvenile idiopathic arthritis and systemic JIA with macrophage activation syndrome — under specialist guidance; higher doses may be used for MAS

Clinical pearls

  • Neoral and Sandimmun are different formulations with different bioavailability profiles — do NOT switch between formulations without close monitoring of trough levels; specify brand on prescription
  • Nephrotoxicity monitoring: if creatinine rises >30% above baseline on two consecutive measurements, reduce dose by 25–50%; if no response, stop
  • Hypertension — amlodipine is the preferred antihypertensive as it does not inhibit CYP3A4 (diltiazem and verapamil do, raising ciclosporin levels dangerously)
  • Maximum duration in RA: 1 year per course (cumulative nephrotoxicity risk); ciclosporin is typically not a long-term DMARD for RA
  • Ciclosporin + methotrexate combination: used in refractory RA — MHRA monitoring required for both nephrotoxicity and hepatotoxicity

Contraindications

  • Uncontrolled hypertension
  • Uncontrolled infection
  • Malignancy (except non-melanoma skin cancer in some indications)
  • Renal impairment (except where disease-related)
  • Concomitant nephrotoxic drugs

Side effects

  • Nephrotoxicity — most important long-term limitation; dose-dependent
  • Hypertension — occurs in 50% of patients; treat with amlodipine (not diltiazem/verapamil — CYP3A4 inhibitors raise ciclosporin levels)
  • Hypertrichosis and gingival hyperplasia
  • Tremor
  • Hyperkalaemia
  • Hyperlipidaemia
  • Increased skin cancer risk
  • Hepatotoxicity

Interactions

  • CYP3A4 inhibitors (erythromycin, clarithromycin, diltiazem, verapamil, azole antifungals, grapefruit juice) — increase ciclosporin levels significantly; toxicity risk
  • CYP3A4 inducers (rifampicin, St John's Wort, carbamazepine, phenytoin) — reduce ciclosporin levels; therapeutic failure
  • NSAIDs — additive nephrotoxicity; avoid or use lowest dose with renal monitoring
  • Statins — increased risk of myopathy; avoid simvastatin; use lowest dose rosuvastatin/pravastatin
  • Colchicine — neuromuscular toxicity; use with caution

Monitoring

  • Serum creatinine and electrolytes fortnightly for first 3 months, then monthly
  • Blood pressure at each visit
  • LFTs monthly
  • Ciclosporin trough levels (if monitoring compliance or toxicity)
  • Lipid profile 3-monthly
  • Skin surveillance annually

Reference: BNFc; BNF 90; BSR/BHPR Rheumatoid Arthritis Guidelines; MHRA Ciclosporin Monitoring Guidance; SPC Neoral. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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