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Calcineurin Inhibitor (CNI) Pregnancy: Use with specialist guidance — maintained in pregnancy in transplant patients; hypertension and preeclampsia risk

Ciclosporin

Brand names: Neoral, Sandimmun

Adult dose

Dose: Renal transplant: 10–15 mg/kg/day initially (divided BD), reduce to 2–6 mg/kg/day maintenance. Nephrotic syndrome: 2.5–5 mg/kg/day BD. Target C2 (2h post-dose) levels: 800–1400 ng/mL early post-transplant.
Route: Oral (Neoral microemulsion preferred — better bioavailability than Sandimmun)
Frequency: Twice daily
Max: Per protocol and trough/C2 levels
Neoral and Sandimmun are NOT bioequivalent — do not interchange. Consistent dosing time relative to meals essential. Avoid grapefruit.

Paediatric dose

Dose: 5 mg/kg
Route: Oral
Frequency: Twice daily (initial post-transplant: 5 mg/kg BD)
Max: Titrate to whole-blood trough or 2-hour level (C2) per transplant protocol
Concentration: 25 mg/mL oral solution; 25 mg, 50 mg, 100 mg capsules mg/ml
BNFc paediatric transplant (specialist initiation): 3–6 mg/kg orally BD initially (typically 5 mg/kg BD post-renal transplant). Trough-level or C2-level targeted. Children typically need higher mg/kg doses than adults due to faster clearance. Neoral and Sandimmun are NOT bioequivalent — do not interchange. Avoid grapefruit.

Dose adjustments

Renal

Nephrotoxic — dose adjusted to levels; avoid NSAIDs, aminoglycosides co-use

Hepatic

Extensive hepatic metabolism — reduce dose in hepatic impairment, monitor levels

Paediatric weight-based calculator

BNFc paediatric transplant (specialist initiation): 3–6 mg/kg orally BD initially (typically 5 mg/kg BD post-renal transplant). Trough-level or C2-level targeted. Children typically need higher mg/kg doses than adults due to faster clearance. Neoral and Sandimmun are NOT bioequivalent — do not interchange. Avoid grapefruit.

Clinical pearls

  • C2 monitoring (2h post-dose) better than trough for therapeutic monitoring of Neoral
  • Gingival hyperplasia: dental hygiene review regularly; may require azithromycin or switch to tacrolimus if severe
  • Hirsutism problematic especially in women — consider switch to tacrolimus if distressing
  • Grapefruit juice contraindicated — inhibits CYP3A4

Contraindications

  • Concomitant tacrolimus (additive nephrotoxicity)
  • Uncontrolled hypertension
  • Uncontrolled infection
  • Malignancy (most)

Side effects

  • Nephrotoxicity
  • Hypertension
  • Gingival hyperplasia
  • Hirsutism
  • Tremor
  • Hyperlipidaemia
  • Hyperkalaemia
  • Hypomagnesaemia
  • Lymphoma risk

Interactions

  • Strong CYP3A4 inhibitors — markedly increase ciclosporin levels
  • Strong CYP3A4 inducers — markedly reduce levels (rifampicin, St John's Wort)
  • Statin interaction — increased myopathy risk (lovastatin/simvastatin avoid; use pravastatin)
  • Bosentan — contraindicated (severe increase in bosentan levels)
  • NSAIDs — additive nephrotoxicity

Monitoring

  • Ciclosporin levels (C0 or C2)
  • Renal function (creatinine, eGFR)
  • Blood pressure (frequent)
  • LFTs
  • Lipid profile
  • Potassium and magnesium

Reference: BNFc; BNF; KDIGO Transplant Guidelines; UK Renal Association; BNF for Children. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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