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INCRELEX® contains human insulin-like growth factor-1 produced by recombinant DNA technology (rhIGF-1). IGF-1 is a key hormonal mediator on growth stature.1
Under normal circumstances, GH binds to its receptor in the liver, and other tissues, and stimulates the synthesis and secretion of IGF-1. In target tissues, the type 1 IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes resulting in growth stature.1
The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.1
Mechanism of Action
Adverse reactions occurring with Increlex in ≥5% of patients in clinical studies* included.1:
Hypoglycemia was reported by 30 patients (42%) at least once during their course of therapy 1
No patients withdrew from any clinical study because of adverse reactions1
* In clinical studies of 71 patients with Primary IGFD treated for a mean duration of 3.9 years and representing 274 patient years.3
In clinical trials, INCRELEX® improved statural growth in patients diagnosed with SPIGFD.1
Data (95% confidence intervals) shown are from individuals treated continually in five pooled clinical studies (four open-label and one double-blind, placebo-controlled) conducted in 71 pediatric subjects with Severe Primary IGF-1 Deficiency. Pretreatment height velocity was available for 58 subjects. Adapted from INCRELEX® full prescribing information.1
Adapted from INCRELEX® full prescribing information.1 SDS, standard deviation score.1 Data (95% confidence intervals) shown are from individuals treated in five pooled clinical studies (four open-label and one double-blind, placebo-controlled) conducted in 71 pediatric subjects with severe primary IGFD. The average height SDS was -6.7 + or – 1.8 at baseline for the 61 subjects in the efficacy analysis.
The dosing of INCRELEX® should be individualized for each patient. This should be based on the periodic assessment of each patient’s weight, tolerability, and laboratory parameters.1 Patients should start INCRELEX® treatment on a weight-based dose in the recommended starting dose range of 0.04 to 0.08 mg/kg twice daily, given subcutaneously.1
Adapted from INCRELEX® full prescribing information. The following formula was used to calculate the dosage as units per injection: patient body weight (kg) x single dose of Increlex (mg/kg) x 1 mL/10 mg x 100 units/1 mL† = units/injection. Two doses per day, morning and evening before or after ( plus/minus 20 minutes) a meal or snack (a separation of 12 hours) are recommended.1 †1 mL=1 cc.
Pre-prandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, pre-prandial glucose monitoring should continue. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced.1
If the starting dose of INCRELEX® is tolerated for at least 1 week, the dose may be increased by 0.04 mg/kg per dose up to the maximum dose of 0.12 mg/kg given twice daily.1 Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with primary IGFD and, due to potential hypoglycemic effects, should not be used.1
Appropriate dose adjustments of INCRELEX® are necessary to avoid administering a dose that may be too low for an individual patient. Patients should be weighed and measured frequently, as regular monitoring is critical for proper unit dosing.1
Adapted from INCRELEX full prescribing information.1 BID, twice daily. *Doses greater than 0.12 mg/kg given BID have not been evaluated in children with primary IGFD and, due to the potential risk of neoplasia and hypoglycaemic effects, should not be used. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced.1 Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established.1 If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue.1
Dosing & Administration
INCRELEX® is supplied in a multiple dose glass vial at a concentration of 10 mg per mL (40 mg per vial).1
When prescribing a 30-day supply of INCRELEX® your patients will need a specific number of vials depending on their body weight and dosage regimen as illustrated below. 12
The following formula was used to determine the number of vials per month: patient body weight [kg] x single dose of Increlex [mg/kg] x 2 doses per day x 30 days per month/40 [mg/vial] = vials/month. 11 *If using syringes that measure dose in units, doses in mg/kg must be converted to units using the following formula: patient body weight [kg] x single dose of Increlex [mg/kg] x 1 mL/10 mg x 100 units/1 mL = units/injection.1
Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
INCRELEX® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH.1
Limitations of use: INCRELEX® is not a substitute to GH for approved GH indications. INCRELEX® is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.1
*Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated GH.