Cysteamine - PROCYSBI delayed-release capsules and granules

The single-dose renal study in non-cystinosis subjects defines moderate impairment as indexed eGFR 30-59 and severe impairment as <=29 mL/min/1.73 m2. Increased cysteamine exposure was judged not clinically meaningful. Four-hour hemodialysis removed about 4.3% of the 600 mg study dose; this is not a supplemental-dose instruction.

For therapeutic monitoring, obtain WBC cystine at 12 hours after the last PROCYSBI dose, before the next dose. Record actual dose and sampling times. Assay-specific targets matter; values from different assay methods may not be comparable. Before increasing a dose for an above-target result, assess adherence, dose-to-draw timing, dosing interval and food administration.

Keep immediate-release monitoring and dosing separate.

The renal study used a single 600 mg dose in subjects without cystinosis. The mirror describes higher exposure in moderate/severe impairment and in hemodialysis subjects; it considers the exposure increases not clinically meaningful. Approximately 4.3% of the study dose was removed during four-hour dialysis.

The retrieved severe-impairment range loses its inequality sign. That malformed range is withheld, not reconstructed. The separately cited official paragraph supplies its own legible threshold. Removal of part of a study dose does not establish a routine supplemental dose or a switching schedule.