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Lupus Nephritis Pregnancy: Contraindicated — teratogenic in animal studies; effective contraception required during and for 1 week after last dose

Voclosporin

Brand names: Lupkynis

Adult dose

Dose: 23.7 mg (3 capsules) twice daily
Route: Oral
Frequency: Twice daily
Max: 23.7 mg BD
Novel calcineurin inhibitor (CNI) — structurally similar to cyclosporin but with improved PK/PD. Used in combination with MMF for active lupus nephritis. Do NOT use with tacrolimus or cyclosporin. Dose reduce if eGFR falls >20% from baseline.

Paediatric dose

Route: Oral
Seek specialist opinion — not licensed in children

Dose adjustments

Renal

Contraindicated if eGFR <45 mL/min at initiation. If eGFR falls >20% from baseline sustained over 2 weeks — reduce dose to 15.8 mg BD. If eGFR falls >30% — interrupt treatment.

Hepatic

Contraindicated in severe hepatic impairment; reduce dose in moderate impairment

Clinical pearls

  • AURORA-1 trial (Rovin et al. Lancet 2021): voclosporin + MMF + low-dose steroids vs MMF + placebo in lupus nephritis — significantly higher complete renal response at 52 weeks (41% vs 23%). Rapid onset of action.
  • AURORA-2 extension: durable benefit maintained at 3 years. NICE TA850 (2022): approved for adults with active lupus nephritis.
  • Advantage over tacrolimus and cyclosporin: more predictable PK without need for routine TDM (therapeutic drug monitoring not required — unlike tacrolimus); lower hypertension and dyslipidaemia burden
  • eGFR monitoring is critical: if eGFR falls >20% from baseline over 2 consecutive readings 2 weeks apart — dose reduce. If >30% fall — interrupt. This protects against CNI-mediated nephrotoxicity superimposed on underlying lupus nephritis.
  • Triple combination: voclosporin + MMF + low-dose prednisolone is now a standard induction regimen in UK for lupus nephritis. Combination with belimumab under investigation.

Contraindications

  • eGFR <45 at initiation
  • Severe hepatic impairment
  • Concomitant strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) — markedly increase CNI exposure
  • Concomitant tacrolimus or cyclosporin
  • Pregnancy

Side effects

  • Nephrotoxicity (eGFR monitoring mandatory)
  • Hypertension
  • Infections
  • Hyperkalaemia
  • Hyperuricaemia/gout
  • Tremor
  • Hypertrichosis (less than cyclosporin)
  • Dyslipidaemia (less than cyclosporin)

Interactions

  • Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) — CONTRAINDICATED (dramatically increase voclosporin levels)
  • Moderate CYP3A4 inhibitors (fluconazole, diltiazem, verapamil) — avoid or reduce dose
  • Strong CYP3A4 inducers (rifampicin) — avoid (reduce efficacy)
  • Grapefruit juice — avoid
  • Other nephrotoxins (NSAIDs, aminoglycosides) — increased nephrotoxicity risk

Monitoring

  • eGFR (baseline, then every 2 weeks for first month, then monthly)
  • Blood pressure
  • Potassium
  • Uric acid
  • Urinary protein:creatinine ratio
  • FBC and LFTs

Reference: BNFc; BNF 90; AURORA-1 Trial (Rovin et al. Lancet 2021); NICE TA850 (2022); SPC Lupkynis. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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