voclosporin: clinical use

Prescribing considerations

• Initiation and supervision should be by a clinician experienced in lupus nephritis.
• Review renal function, hepatic function, interacting medicines, blood pressure, potassium and pregnancy potential before treatment.
• Data are limited in older adults and reduced kidney function; use is not recommended in severe hepatic impairment or people older than 75 years.
• Avoid live vaccines and minimise unprotected sunlight or ultraviolet exposure because of immunosuppression-associated infection and malignancy risks.
• Safety and efficacy with cyclophosphamide have not been established.

Contraindications and cautions

• Hypersensitivity to voclosporin or an excipient.
• Concomitant strong CYP3A4 inhibitors.
• Previous anaphylactic reaction to soya or peanut because the product may contain trace soya lecithin.

Monitoring

• Establish baseline eGFR and monitor closely, particularly early in treatment and after relevant medicine changes.
• Monitor blood pressure and serum potassium.
• Assess for infection, neurotoxicity, acute kidney injury and clinically significant hypertension.
• Review for QT-risk factors and interacting medicines.
• Reassess benefit and risk during treatment; routine voclosporin concentration monitoring is not specified in the SmPC.

Clinical pharmacology

Voclosporin inhibits calcineurin, suppressing T-cell activation, lymphocyte proliferation and cytokine production. It is extensively metabolised mainly by CYP3A4, is highly protein bound and inhibits P-glycoprotein and OATP1B1/OATP1B3 transporters.

Formulation and product differences

• The selected product is an oral soft capsule that must be swallowed whole.
• The capsule contains gelatin, ethanol and sorbitol and may contain trace soya lecithin.
• Store in the original blister to protect it from moisture.

Capsule

Route: Oral

Strengths: 7.9 mg