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Accretropin

Clinical Pharmacology
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Clinical Pharmacology

Accretropin

Excretion — Urinary excretion of intact somatropin has not been measured.

Table 1: Summary of somatropin pharmacokinetic parameters in the normal population following a 4 mg dose of Accretropin™ administered subcutaneously*

  AUC(0-t)
(ng•h/mL)		 AUC(0-inf)
(ng•h/mL)		 Cmax
(ng/mL)		 Tmax (h) t1/2 (h)
mean ± SD 238.09 ± 44.11 255.31 ± 43.03 29.49 ± 8.32 3.50 (2-6) 3.63 ± 1.33
*Abbreviations: AUC0-t=area under the curve until 24 hours after administration; AUC0-inf=area under the curve to infinity; Cmax=maximum concentration; t½=half-life; Tmax=time to maximum concentration (given as the median value with range); SD=standard deviation.

Special Populations

Geriatric — The pharmacokinetics of Accretropin™ have not been studied in patients greater than 65 years of age.

Pediatric — No formal pharmacokinetic studies of r-hGH in pediatric patients have been conducted using Accretropin™.

Gender — No studies have been performed to evaluate the effect of gender on the pharmacokinetics of Accretropin™.

Race — No data are available.

Renal, Hepatic insufficiency — No studies have been performed with Accretropin™ in patients with renal or hepatic insufficiency.

Figure 1. Mean serum hGH levels over time following single dose administration.

Mean serum hGH levels over time following single dose administration - illustration

Figure 1 shows changes in mean hGH serum concentrations over time following single dose administration of Accretropin™ (N= 20, data represent means ± Standard Error).

Clinical Trials

Pediatric Patients with GHD

The safety and efficacy of Accretropin™ in the treatment of pediatric patients with GHD was studied in a single-arm, open-label, multicenter trial conducted in 44 patients with GHD who were treated for up to 3 years with an Accretropin™ dose of 0.03 to 0.05 mg/kg/day (0.18 to 0.30 mg/kg/week) subcutaneously. The efficacy of Accretropin™ is displayed in Table 2.

Table 2: Height Velocity (cm/yr) and Height Velocity SDS in patients with GHD*

  Height Velocity (cm/yr)
N= number of patients
Mean (cm/yr) ± SD		 Height Velocity SDS
N= number of patients
Mean (SDS) ± SD
Year 1 N=41
8.88 ± 2.29		 N=41
3.60 ± 3.58
Year 2 N=34
7.64 ± 1.41		 N=33
1.95 ± 2.32
Year 3 N=26
6.98 ± 1.62		 N=26
1.76 ± 2.87
*Patients who entered puberty during the clinical trial were discontinued as per protocol specifications.

Height SD score calculated relative to population of normally growing children increased on Accretropin™ treatment from -3.04 at baseline to -2.46 at one year, -2.12 at two years, and -1.78 at three years.

Pediatric Patients with Turner Syndrome

The safety and efficacy of Accretropin™ in the treatment of children with short stature due to Turner Syndrome was evaluated in a single-arm, open-label, single-center trial conducted in 37 patients treated with an Accretropin™ dose of 0.06 mg/kg/day subcutaneously (0.36 mg/kg/week). The efficacy of Accretropin™ is shown in Table 3.

Table 3: Height Velocity (cm/yr) and Height Velocity SDS in patients with Turner Syndrome

  Height Velocity (cm/yr)
N= number of patients
Mean (cm/yr) ± SD		 Height Velocity SDS
N= number of patients
Mean (SDS) ± SD
Year 1 N=37
8.56 ± 1.71		 N=37
3.08 ± 2.56
Year 2 N=36
6.85 ± 1.21		 N=36
1.50 ± 1.90
Year 3 N=35
5.84 ± 1.86		 N=33
0.48 ± 3.28

Brand Name: Accretropin
Generic Name: Somatropin Injection
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