Pharmacokinetics Of Teduglutide In Subjects With Renal Impairment

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AusPAR Attachment 1. Product Information for Teduglutide

increased with the degree of renal impairment following a single subcutaneous administration of 10 mg teduglutide. Teduglutide exposure increased by a factor of 2.1 (C. max) and 2.6 (AUC. 0-inf) in ESRD subjects compared to healthy subjects. The AUC and C. max. values of subjects with mild renal impairment were 50% higher

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Glepaglutide 10 mg twice weekly (43 subjects) Glepaglutide 10 mg once weekly (43 subjects) Placebo (43 subjects) Screening Run-in Treatment Follow-up Weeks from first screening 1:1:1 randomization Trial design1 Double-blind, placebo controlled trial in 129 SBS patients evaluating safety and efficacy of once and twice weekly dosing over 24 weeks

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

and severe renal impairment (creatinine clearance less than 50ml/min), and end-stage renal disease, the daily dose should be reduced by 50% (see section5.2). Hepatic impairment No dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects.

[Product Monograph Template - Standard]

Patients with Renal Impairment Reduce the dose by 50% in adult patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min), and end-stage renal disease. No dose adjustment is necessary for patients with mild renal impairment. No pediatric patients with renal insufficiency were included in trials.

HIGHLIGHTS OF PRESCRIBING INFORMATION ELOCTATE ELOCTATE

Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses. Base the dose and frequency of ELOCTATE on the individual clinical response.

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least 8 subjects who are teduglutide-naïve will be enrolled into the SOC treatment arm. Enrollment will proceed at approximately 28 investigational sites globally. Attempts will be made to enroll into each teduglutide dose group at least 1 subject younger than 1 year and at least 2 subjects aged 12 to <17 years.

Reference ID: 3237516

ELIQUIS is not recommended in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)]. 2.7 Renal Impairment The dosing adjustment for moderate renal impairment is described above [see Dosage and Administration (2.2)]. No data inform use in patients with creatinine clearance <15 mL/min or on dialysis. 3 DOSAGE FORMS AND

AusPAR Attachment 2: Extract from the Clinical Evaluation

hepatic impairment based on a study conducted in Child-Pugh grade B subjects. Teduglutide has not been formally studied in subjects with severe hepatic impairment. Renal impairment: Reduce the dose by 50% in patients with moderate and severe renal impairment (creatinine clearance less than 50 mL/min), and end-stage renal disease. No

203441Orig1s000 - Food and Drug Administration

Nov 30, 2011 renal impairment or end stage renal disease (ESRD), teduglutide Cmax and AUC0-∞ increased with increasing degree of renal impairment. The primary PK parameters of teduglutide increased up to a factor of 2.6 (AUC0-∞) and 2.1 (Cmax) in ESRD subjects compared to healthy subjects (Study CL0600-018). Based on these results, SBS patients with

[Product Monograph Template - Standard]

Across all clinical studies, 595 subjects were exposed to at least one dose of REVESTIVE (249 patient-years of exposure; mean duration of exposure was 22 weeks). Of the 595 subjects, 173 subjects were treated in Phase 3 SBS studies (134/173 [77%] at the dose of 0.05 mg/kg/day and 39/173 [23%] at the dose of 0.10 mg/kg/day).