Pharmacokinetics of recombinant factor VIII (Kogenate‐FS<sup>®</sup>) in children and causes of inter‐patient pharmacokinetic variability
Bibliographic record
Abstract
Summary. Understanding the pharmacokinetics (PK) of factor VIII (FVIII) is important in the management of patients with haemophilia A. We studied the PK of FVIII in order to determine aetiological factors contributing to PK variability of FVIII in children. Twenty children with haemophilia A (mean age 12.8 years) were administered a single bolus of 50 U kg−1 of recombinant FVIII (rFVIII; Kogenate‐FS®, Bayer). The mean incremental FVIII recovery was 1.87 (U mL−1)/(U kg−1) (range: 1.25–2.76) and the mean FVIII half‐life was 10.7 h (range: 7.8–15.3). FVIII recovery was positively correlated with body surface area (BSA; P = 0.04). FVIII half‐life was positively correlated with preinfusion levels of von Willebrand factor antigen (VWF:Ag) (P = 0.0001) and was reduced in patients (n = 6) with very low FVIII inhibitor titres (<0.5 BU) vs. those (n = 14) with negative inhibitor titres (P = 0.06). These observations suggest that (i) young children with haemophilia in comparison with adults have a low recovery of FVIII and that this might be explained by differences in body composition (BSA, plasma volume), (ii) levels of VWF:Ag may explain some of the differences in the half‐life and clearance of FVIII and (iii) very low inhibitor titres, previously regarded as clinically insignificant, may actually be significant and should be evaluated in the context of PK studies.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".