CloseClose
Find a Drug
Advanced Search

Professional

Increlex

Clinical Pharmacology
font size

Clinical Pharmacology

Increlex

n

3

3

3

3

12a

12a

Mean CV%

234 23

2 0

2932 50

5.8 64

0.257 28

0.0424 38

cmax = maximum concentration; tmax = time of maximum concentration; AUC0-8 = area under the curve; t1/2 = half-life; Vd/F = volume of distribution; CL/F = systemic clearance; SC = subcutaneous injection; CV% = coefficient of variation in %.

Male/female data combined, ages 12 to 22 years.
a Data represents 3 subjects each at doses 0.015, 0.03, 0.06, and 0.12 mg/kg SC.
PK parameters based on baseline adjusted plasma concentrations.

Mean Total IGF-1 Concentration after a Single Subcutaneous Dose of INCRELEX in Children with
Severe Primary IGFD (0.06 mg/kg and 0.12 mg/kg, n = 3 per group)

Special Populations

Geriatric The pharmacokinetics of INCRELEX have not been studied in subjects greater than 65 years of age.

Gender In children with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.

Race No information is available.

Renal insufficiency No studies have been conducted in Primary IGFD children with renal impairment.

Hepatic insufficiency - No studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of rhIGF-1.

CLINICAL TRIALS

Effects of INCRELEX Treatment in Children with Severe Primary Insulin-like Growth Factor-1 Deficiency (Primary IGFD)

Five clinical studies (four open-label and one double-blind, placebo-controlled), with subcutaneous (SC) doses of INCRELEX generally ranging from 0.06 to 0.12 mg/kg (60 to 120 µg/kg) administered twice daily (BID), were conducted in 71 pediatric subjects with severe Primary IGFD. Patients were enrolled in the trials on the basis of extreme short stature, slow growth rates, low IGF-1 serum concentrations, and normal growth hormone secretion. Data from these 5 clinical studies were pooled for a global efficacy and safety analysis. Baseline characteristics for the patients evaluated in the primary and secondary efficacy analyses were (mean, SD): chronological age (years): 6.7 ± 3.8; height (cm): 84.8 ± 15.3 cm; height standard deviation score (SDS): -6.7 ± 1.8; height velocity (cm/yr): 2.8 ± 1.8; height velocity SDS: -3.3 ± 1.7; IGF-1 (ng/mL): 21.6 ± 20.6; IGF-1 SDS: -4.3 ± 1.6; and bone age (years): 4.2 ± 2.8. Sixty-one subjects had at least one year of treatment. Fifty-three (87%) had Laron Syndrome; 7 (11%) had GH gene deletion, and 1 (2%) had neutralizing antibodies to GH. Thirty-seven (61%) of the subjects were male; forty-eight (79%) were Caucasian. Fifty-six (92%) of the subjects were prepubertal at baseline.

Annual results for height velocity, height velocity SDS, and height SDS are shown in Table 1. Pre-treatment height velocity data were available for 58 subjects. The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.

Table 1: Annual Height Results by Number of Years Treated with INCRELEX

Pre-Tx

Year 1

Year 2

Year 3

Year 4

Year 5

Year 6

Year 7

Year 8
Height Velocity (cm/yr)
Brand Name: Increlex
Generic Name: Mecasermin [rDNA origin] Injection
Bookmark this page:

Privacy Policy

Women's Health

Find out what women really need.

WebMD Symptom Checker - Start Here Ringworm Slideshow: Watch and Learn

Herbal First AidHerbal First Aid
Herbal medicine is ancient, but only in recent years have many people started to take notice of its all natural healing powers. See more WebMD Videos »