tacrolimus and Thrombophlebitis

The safety and pharmacokinetics of anidulafungin coadministered with tacrolimus were investigated using a single-sequence, open-label design. Healthy volunteers received 5 mg tacrolimus orally on days 1 and 13 of the study. Anidulafungin (200 mg) was administered intravenously on day 4, followed by 100-mg doses on days 5 through 13. Key pharmacokinetic parameters, including C(max), AUC, t((1/2)), CL, and V(ss), were derived from concentration-time data. The 90% confidence intervals (CIs) of the ratios of mean pharmacokinetic parameters of anidulafungin plus tacrolimus to each drug alone were well within the 80% to 125% bioequivalence range, indicating no pharmacokinetic interaction. This ratio was 101.6 (90% CI: 92.77-111.22) for tacrolimus AUC(0-infinity) and 107.2 (90% CI: 105.1-109.4) for anidulafungin AUC(ss). The 2 drugs were well tolerated, and no drug-related serious adverse events were reported. Because of its lack of pharmacokinetic interaction with key immunosuppressive agents, anidulafungin is an important option for the prevention and treatment of invasive fungal infections in transplant recipients.

Topics: Administration, Oral; Adolescent; Adult; Alanine Transaminase; Anidulafungin; Antifungal Agents; Area Under Curve; Aspartate Aminotransferases; Creatine Kinase; Dizziness; Drug Interactions; Echinocandins; Fatigue; Half-Life; Headache; Humans; Immunosuppressive Agents; Infusions, Intravenous; Male; Middle Aged; Nocturia; Peptides, Cyclic; Tacrolimus; Therapeutic Equivalency; Thrombophlebitis