[105872056]
Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose 300mg, qow, icv; therapy date: unknown date. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[105872057]
On an unreported date, the patient underwent implantation of an ommaya 12 mm (n/a) reservoir and catheter set, and the patient initiated treatment with brineura (300 mg, qow, icv) for the indication of neuronal ceroid lipofuscinosis. On (b)(6) 2017, the patient received his brineura infusion and was de-accessed without complications. Subsequently, the patient's cerebrospinal fluid (csf) protein was reported as normal at 22, glucose was normal at 52, and white blood cell (wbc) and red blood cell (rbc) counts were <(><<)>1 (units and range values unreported). At that time, the patient was discharged home. At approximately 18 hours post-infusion, the patient had a fever with one emesis event. As treatment, the patient took ondansetron and paracetamol. On (b)(6) 2017, the patient's csf showed preliminary results of propionibacterium (p) acnes in thioglycolate broth only. At this time, the patient had his device re-accessed and his csf was normal at 33, glucose was normal at 58, wbc was elevated at 10, and rbc was elevated at 150 (units and range values unreported). On (b)(6) 2017, the patient's csf, again, had preliminary results of p. Acnes in thioglycolate broth only. On (b)(6) 2017, both cultures were confirmed positive for p. Acnes. On (b)(6) 2017, since the patient was asymptomatic with a csf protein of 26 (normal), glucose of 56 (normal), and improved, elevated wbc and rbc of 6 (units and range values unreported), the patient was infused with brineura as planned. On (b)(6) 2017, the patient's ommaya reservoir device was removed and a peripherally inserted central catheter (picc) line was placed for treatment with ceftriaxone. During this time, treatment with brineura was withdrawn. On (b)(6) 2017, the patient's device grew little p. Acnes. It was noted the pathogen was pan-sensitive except to metronidazole. The event was assessed as related to the patient's ommaya reservoir device.
Patient Sequence No: 1, Text Type: D, B5