Formulary
Voclosporin: Indications, Dosing, Side Effects and Interactions
Voclosporin is a calcineurin inhibitor that inhibits production and release of lymphokines, thereby suppressing cell-mediated immune response.
MedNext Academy | 3 min read
Voclosporin: Indications, Dosing, Side Effects and Interactions
Voclosporin is a calcineurin inhibitor that inhibits production and release of lymphokines, thereby suppressing cell-mediated immune response.
Drug action
Voclosporin is a calcineurin inhibitor that inhibits production and release of lymphokines, thereby suppressing cell-mediated immune response.
Indications and dose
**Lupus nephritis (under expert supervision)**
- **Adult** (By Mouth): 18-75 years 23.7 mg twice daily, dose adjusted according to renal function-consult product literature, evaluate treatment continuation after at least 24 weeks.
Cautions
Hypertension; increased risk of infections; increased risk of malignancy; increased risk of neurotoxicity; QT-interval prolongation
Side effects
Common or very common Alopecia; anaemia; appetite decreased; cough; diarrhoea; gastrointestinal discomfort; gingival haemorrhage; hair changes; headache; hyperkalaemia; hypertension; increased risk of infection; nausea; oral disorders; renal impairment; seizure; tremor
Interactions
**Severe interactions:**
- Monitor use of BCRP substrates where small concentration changes may lead to serious toxicity (e.g., rosuvastatin) when used concomitantly with voclosporin.
- MMF Co-administration of voclosporin with mycophenolate mofetil (MMF) had no clinically significant impact on mycophenolic acid (MPA) blood concentrations.
**Other interactions (21):**
- Voclosporin is metabolised by CYP3A4 and is an inhibitor of P-glycoprotein (P-gp) and organic-anion-transporting polypeptide (OATP)1B1 and OATP1B3.
- Potential for other medicinal products to affect voclosporin exposure Voclosporin is metabolised by CYP3A4.
- Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of voclosporin and thereby increase or decrease voclosporin blood levels.
- CYP3A4 inhibitors Voclosporin exposure was 18.6-fold higher in the presence of the strong CYP3A4 inhibitor ketoconazole compared to voclosporin administered alone.
- Voclosporin exposure was 2.71-fold higher in the presence of the moderate CYP3A4 inhibitor verapamil compared to voclosporin administration alone.
- Reduce the dose to 15.8 mg in the morning and 7.9 mg in the evening when voclosporin is co-administered with moderate CYP3A4 inhibitors (e.g., verapamil, fluconazole, erythromycin, diltiazem,...
Pregnancy
Avoid (toxicity in animal studies). M
Breast feeding
Specialist sources indicate large molecular weight suggests limited excretion into milk. Consider an alternative drug, especially if breast-feeding a pre- or full-term neonate (no information available).
Hepatic impairment
Avoid in severe impairment (no information available). M Dose adjustments Reduce starting dose to 15.8 mg twice daily in mild to moderate impairment. M
Renal impairment
Use with caution if eGFR less than 45 mL/minute/1.73 m 2 and only if potential benefit outweighs risk. M Dose adjustments Reduce starting dose to 15.8 mg twice daily if eGFR less than 30 mL/minute/1.73 m 2 . M See Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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