Table 3

Pharmacokinetic parameters of CZP in breast milk after administration of CZP

ParameternGeo. mean (Geo. CV (%))Median
(min–max)
All mothers: both CZP 200 mg Q2W and CZP 400 mg Q4W dosing regimens
 Estimated average daily infant dose (mg/kg/day)170.00426 (59.4)0.003503
(0–0.0104)
 Cave (μg/mL)170.0248 (58.0)0.02335
(0.00744–0.0693)
 tmax (day)135.051
(2.89–11.9)
Mothers on CZP 200 mg Q2W dosing regimen only
 AUCT (day* μg/mL)130.398 (59.4)0.4249
(0.104–0.970)
 Cmax (μg/mL)160.0383 (50.3)0.04285
(BLQ–0.0758)
  • AUCT, area under the curve over a dosing interval (14 or 28 days); Cave, average concentration over a dosing interval;  Cmax, maximum observed CZP concentration in milk over the dosing interval; CV, coefficient of variations; CZP, certolizumab pegol; Geo.: geometric; Q2W, every 2 weeks; Q4W, every 4 weeks; tmax, time of the maximum observed concentration.