|Increlex® (mecasermin [rDNA origin] injection) is the first rhIGF-1 (recombinant human insulin-like growth factor-1) therapy approved in the United States for long-term treatment of growth failure in children with Severe Primary IGFD. It is the optimal therapy for Severe Primary IGFD because it replaces missing IGF-1, the primary mediator of growth in children. This injectable liquid was launched in the United States in January 2006 and in Europe in August 2007. The safety and efficacy of Increlex was demonstrated in clinical trials totally 321 patient years. Physicians may also prescribe Increlex for children whose growth failure is due to growth hormone (GH) gene deletion and who have developed neutralizing antibodies to growth hormone. To learn more about how this novel therapy can help young patients, visit our Increlex website.
Ipsen continues to gather data on the value of Increlex through clinical studies and our IGFD Registry, which monitors the ongoing status of more than 300 patients who are being treated with Increlex.
|Important Safety Information for Increlex
INCRELEX (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to GH. Primary IGFD is defined as height and IGF-1 SDS ≤ -3 and normal or elevated growth hormone.
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.
Almost half of these patients had hypoglycemia prior to IGF-1 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. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. 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.
Please see Full Prescribing Information for additional important information.