|When certain children are much smaller than others their own age, it can be caused by a deficiency of insulin-like growth factor-1 (IGF-1), a naturally occurring hormone that is secreted from the liver and other tissues in response to growth hormone (GH). A majority of the growth-promoting effects of GH are actually due to IGF-1 acting on target cells. In some cases, young people have enough GH, but their IGF-1 levels still remain low. This creates a condition called severe Primary IGF-1 deficiency or, more simply, Severe Primary IGFD. A physician may diagnose Severe Primary IGFD when a child's height is significantly different from other children, and tests show that IGF-1 levels are abnormally low when growth hormone levels are normal or elevated. It is estimated that approximately 6,000 children in the United States have this condition.
In January 2006, Increlex® (mecasermin [rDNA origin] injection), an injectable liquid developed by Tercica, Inc., now Ipsen Biopharmaceuticals, Inc., became available for sale in the United States. Increlex is the first and only product available to replace the IGF-1 that's missing to effectively and safely stimulate growth. Whether you are a physician, parent, caregiver, or patient, you can learn much more about Severe Primary IGFD at Increlex.com.
|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.