Indication:
Voclosporin (a calcineurin inhibitor) is approved in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis. Dosage is not based on patient's body weight. The blood trough concentration should not be monitored.
Dosing:
the recommended starting dose is 3 capsules BID (capsules 7.9mg). Voclosporin should be taken on a full or an empty stomach.
Main Adverse Reactions:
The most common adverse reactions of voclosporin were (>3%), glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain(upper), dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue. tremor, acute kidney injury, and decreased appetite.
Drug interaction:
Some medications, such as ketoconazole, itraconazole, which are antifungals, and clarithromycin, an antibiotic, should not be taken with Voclosporin. Other medications, such as cyclophosphamides, a chemotherapy and immunosuppressive drug, were not studied along with Voclosporin. This means we don’t know the effects of taking the two medicines together. It is important to tell your doctor about all of the medications that you are taking, even over-the-counter medicines, vitamins, and herbal supplements.
Limitations of Use:
Safety and efficacy of Voclosporin have not been established in combination with cyclophosphamide. Use of Voclosporin is not recommended in this situation.
Voclosporin contains some alcohol (21.6 mg per tablet, equivalent of 1ml of wine). Voclosporin should not be used during pregnancy because lack of data.
Contraindications:
Hypersensitivity to the active substance or to one of the excipients.
Patients who are breastfeeding or plan to breastfeed should not take this medication. Voclosporin is not recommended in patients with a baseline eGFR less than or equal to 45 ml/min/1.73 m2 unless benefits exceeds risk. Dose should be reduced if the drug is used within this population as well as for patients who are hepatically impaired.
Live vaccines are contraindicated.