Voclosporin capsules (Lupkynis) - selected U.S. label sections
- Product / population
- Adult LUPKYNIS oral capsules for active lupus nephritis with the labeled background therapy.
- Renal measure
- eGFR in mL/min/1.73 m2, including percentage change from baseline
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Baseline renal eligibility
Baseline eGFR at or below 45: generally not recommended unless benefit exceeds risk; this population was not studied. If treatment is chosen despite severe impairment, the reduced starting dose is 15.8 mg twice daily.
On-treatment renal algorithm
Monitor eGFR every 2 weeks in month 1, every 4 weeks through year 1, then quarterly.
If eGFR is below 60 and falls more than 20% but less than 30% from baseline, reduce each twice-daily dose by 7.9 mg. Recheck within 2 weeks; if the fall remains above 20%, reduce again by 7.9 mg twice daily.
If eGFR is below 60 and the fall is at least 30%, discontinue. Recheck within 2 weeks; consider restarting 7.9 mg twice daily only after recovery to at least 80% of baseline. After a renal-driven reduction, consider increasing by 7.9 mg twice daily for each measurement at least 80% of baseline, without exceeding the starting dose.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f489295-1156-52c7-5fd0-5c4c52f9b813