The safety profile of Increlex® has been extensively evaluated in long-term clinical trials.
Five clinical studies were conducted in 71 pediatric subjects with severe Primary IGFD to evaluate the efficacy and safety of Increlex®.1 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.1
Baseline Patient Characteristics: 61 treatment-naïve patients who completed at least 1 year of Increlex therapy1
|Chronological age (years)||6.7||3.8|
|Height SD Score||-6.7||1.8|
|Pre-treatment height velocity (cm/yr)||2.8||1.8|
|Pre-treatment height velocity SD Score||-3.3||1.7|
|IGF-1 SD Score||-4.3||1.6|
|Bone age (years)||4.2||2.8|
Data from clinical studies were pooled for efficacy and safety analysis.1 61 na´ve subjects had at least 1 year of growth data and 53 (87%) of the 61 subjects had Laron Syndrome.1 Mean treatment duration was 3.9 years, representing 274 subject-years.1 Subjects received subcutaneous injections of Increlex administered twice daily with doses generally ranging from 0.06 to 0.12 mg/kg per injection.1
Children treated with Increlex demonstrated statistically significant improvements in statural growth, including more than a doubling in height velocity and maintenance of "catch-up" growth.1
Ipsen is committed to the ongoing collection of long-term data and has established the Increlex Growth Forum Database (IGFD); a patient registry program monitoring the long-term safety and efficacy of Increlex. It allows physicians to register and enter information regarding their experiences with Increlex on a real-time basis. Over 650 patients are enrolled and this number will continue to grow.29 For more information or to contact a Clinical Registry Liaison, click here.
INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. 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 growth hormone (GH). Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.
Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.
INCRELEX is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops. INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions and Adverse Reactions]. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used for growth promotion in patients with closed epiphyses.
INCRELEX has insulin-like hypoglycemic effects and should be administered 20 minutes before or after a meal or snack. Hypersensitivity and allergic reactions have been reported, including a low number of cases indicative of anaphylaxis requiring hospitalization. Intracranial hypertension has occurred in patients treated with INCRELEX. Funduscopic examination is recommended at the initiation of and periodically during the course of therapy. Patients should have periodic examinations to rule out potential complications from tonsillar/adenoidal hypertrophy and receive appropriate treatment if necessary. Children with onset of limp or hip/knee pain should be evaluated for possible slipped capital femoral epiphysis. Monitor any child with scoliosis for progression of the spine curve.
In clinical studies of 71 pediatric subjects with severe Primary IGFD representing 274 patient-years of treatment, no subjects discontinued due to adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy with INCRELEX. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX. Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX treatment. INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.
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