Drug updated on 4/16/2024
| Dosage Form | Capsule (oral; 7.9 mg) |
| Drug Class | Calcineurin inhibitor immunosuppressants |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Used in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis.
Summary
- Voclosporin (Lupkynis) is used in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis.
- A total of 1 systematic review/meta-analysis document was reviewed, which included randomized controlled trials evaluating voclosporin's effectiveness and safety when combined with other drugs like mycophenolate mofetil (MMF), tacrolimus or belimumab.
- The study found that multitarget therapies such as voclosporin+MMF showed significantly higher complete remission rates compared to monotherapy treatments in adults suffering from lupus nephritis.
- Subgroup analysis revealed that both tacrolimus+MMF and voclosporin+MMF groups, as well as the belimumab plus standard care group had significantly higher complete remission rates than those receiving monotherapy or standard care alone.
- While there were no significant differences between adverse events reported by participants on multitarget therapy versus those on monotherapy, cases of infection and pneumonia were numerically more elevated among individuals treated with multitarget therapies including Lupkynis.
- Notably, new-onset hypertension was considerably higher among patients treated using a combination of tacrolimus + MMF compared to cyclophosphamide group while incidence of menstrual disorder was lower in this same patient population indicating potential subgroup considerations for prescribing decisions involving Lupkynis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lupkynis (voclosporin) Prescribing Information. | 2021 | Aurinia Pharma U.S, Rockville, MD |