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Calcineurin Inhibitor (CNI) Pregnancy: Use with specialist guidance — tacrolimus maintained through pregnancy in transplant recipients; risk of preterm birth, low birth weight

Tacrolimus

Brand names: Prograf, Advagraf (MR), Modigraf

Adult dose

Dose: Post-renal transplant: Initial 0.1–0.15 mg/kg/day (Prograf BD) or 0.15–0.2 mg/kg/day (Advagraf OD). Target trough level 8–20 ng/mL (early); 5–10 ng/mL (long-term).
Route: Oral (BD for Prograf, OD for Advagraf — NOT interchangeable)
Frequency: BD (Prograf) or OD (Advagraf)
Max: Dose adjusted to target trough levels
Never substitute between brands without specialist guidance — different pharmacokinetic profiles. Narrow therapeutic index. Avoid grapefruit juice.

Paediatric dose

Dose: 0.15 mg/kg
Route: Oral
Frequency: Twice daily (Prograf/Adoport: 0.15 mg/kg per dose BD initially)
Max: Titrate to whole-blood trough level (specialist transplant protocol)
Concentration: 0.5 mg, 1 mg, 5 mg capsules; 0.2 mg/g granules (Modigraf) mg/ml
BNFc paediatric transplant (specialist initiation): immediate-release tacrolimus (Prograf/Adoport) 0.15 mg/kg orally BD initially; modified-release (Advagraf) 0.20 mg/kg OD. Trough-level targeted (typically 5–15 ng/mL early post-transplant; lower long-term). Children typically need higher mg/kg doses than adults due to faster clearance. Never substitute between brands — different PK.

Dose adjustments

Renal

Dose adjustment based on trough levels; nephrotoxicity is a major concern

Hepatic

Significant hepatic metabolism — reduce dose in hepatic impairment; monitor levels closely

Paediatric weight-based calculator

BNFc paediatric transplant (specialist initiation): immediate-release tacrolimus (Prograf/Adoport) 0.15 mg/kg orally BD initially; modified-release (Advagraf) 0.20 mg/kg OD. Trough-level targeted (typically 5–15 ng/mL early post-transplant; lower long-term). Children typically need higher mg/kg doses than adults due to faster clearance. Never substitute between brands — different PK.

Clinical pearls

  • Brands are NOT interchangeable — prescribe by brand name and strength always
  • Monitor whole blood trough levels (before next dose) — target varies by time post-transplant and indication
  • Hyperglycaemia post-transplant (NODAT) is common — monitor fasting glucose at every review
  • Hypomagnesaemia common — supplement routinely; also associated with neurotoxicity

Contraindications

  • Hypersensitivity to polyoxyl castor oil (IV formulation)
  • Concomitant ciclosporin (additive nephrotoxicity — switch sequentially)

Side effects

  • Nephrotoxicity (dose-dependent, acute and chronic)
  • Neurotoxicity (tremor, headache, seizures)
  • Hyperglycaemia/NODAT (new onset diabetes)
  • Hypertension
  • Hyperkalaemia
  • Hypomagnesaemia
  • Alopecia
  • Opportunistic infections
  • Lymphoma (long-term)

Interactions

  • Strong CYP3A4 inhibitors (azole antifungals, macrolides, diltiazem, verapamil) — markedly increase tacrolimus levels
  • Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin) — reduce tacrolimus levels
  • Grapefruit juice — increases levels
  • Potassium-sparing diuretics — hyperkalaemia risk
  • NSAIDs — nephrotoxicity

Monitoring

  • Tacrolimus whole blood trough levels (at least weekly initially)
  • Renal function and electrolytes (potassium, magnesium)
  • Blood glucose (NODAT)
  • Blood pressure
  • FBC and LFTs
  • Neurological symptoms

Reference: BNFc; BNF; KDIGO Transplant Guidelines 2009; UK Renal Association. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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