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Diagnostic Considerations

Various tests and tools can guide you in the differential diagnosis of your patients.

Monitor and Reevaluate Your Patients

If a child is tracking below the average, this can be an indication that the child needs to be evaluated or perhaps reevaluated to determine a specific diagnosis.

Increlex® for Patients with Severe Primary IGFD

Increlex® (mecasermin [rDNA origin] injection) is the only FDA-approved therapy for long-term treatment of growth failure in patients with severe Primary IGF-1 Deficiency.

Growth Tracking Tool

Monitor your patient's growth over time. Plot your patient's growth electronically using our interactive Growth Tracking Tool.

Dynamics of Growth and Severe Primary IGFD

Linear growth and physical maturation are dynamic processes encompassing molecular, cellular, somatic and organismal changes.2 At various developmental intervals, a child's growth can be compared to that of his or her peers by referring to the norm on an appropriate growth chart.2 Following a period of decelerating height velocity, growth virtually ceases after epiphyseal fusion generally around age 15 for girls and age 17 for boys.2

Although any single point on a growth chart is not very informative, when several growth points are plotted over time, an individual's growth rate can be evaluated against known averages for that age and gender and then determined to be either average, a variant of the norm or pathologic (growth failure).2 Children who are shorter than 97.7% of peers of the same age and sex are described as having short stature.22,23 Failure to grow and/or short adult height can be caused by several factors including family history (genetics), chronic disease and endocrine function.23

Monitoring and Reevaluating Growth

Response to GH varies by diagnosis, as well as by age and gender. Growth charts track the growth of children and adolescents and contribute to the overall clinical impression for the child being measured. These charts allow you to compare normal growth with that of other children (age in years 2-20) based on specific age and gender. If a child is tracking below the average this can be an indication that the child needs to be evaluated or perhaps reevaluated to determine a specific diagnosis.

If the child was previously diagnosed with a growth disorder and treated with GH, the reevaluation should include an assessment of compliance, whether the GH dose needs to be adjusted, and whether other diagnoses, including severe Primary IGFD, should be considered.

Indication and Important Safety Information

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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