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Indication and Important Safety Information 1
INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe Primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe Primary 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 patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; 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.
INCRELEX is not a substitute for GH treatment.
INCRELEX should not be used for growth promotion in patients with closed epiphyses. INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used by patients who are allergic to mecasermin (IGF-1) or any of the inactive ingredients in INCRELEX.
INCRELEX contains benzyl alcohol as a preservative, which has been associated with neurologic toxicity in neonates.
INCRELEX has not been studied in patients under 2 years old.
Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Local or systemic allergic reactions may occur.
In clinical studies of 71 subjects with severe Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse events.
Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. Most cases 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. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Hypoglycemia was generally avoided when a meal or snack was consumed either shortly before or shortly after administration.
Tonsillar hypertrophy was noted in 11 subjects (15%) 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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