Therapeutic and toxic ranges are not well established. Concentrations greater than 40.000 µg/mL tend to correlate with improved patient outcome. A proposed therapeutic range is 50.000 - 100.000 µg/mL. Adverse reactions to Leflunomide, such as diarrhea, hypertension, and liver toxicity, do not correlate well with serum drug concentrations. Leflunomide has a potential risk for teratogenesis. For women being treated with Leflunomide who desire to become pregnant, enhanced drug elimination should be performed until plasma teriflunomide concentrations are lower than 0.020 µg/mL on two separate tests taken at least 14 days apart.
Statement B: Compliance Statement B
: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.