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 should not be used for growth promotion in patients with closed epiphyses.

Increlex is not a substitute for GH treatment. 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. Benzyl alcohol as a preservative has been associated with neurologic toxicity in neonates. If sensitivity to Increlex occurs, treatment should be discontinued.

Increlex is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.

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. Patients should have periodic examinations to rule out such potential complications and receive appropriate treatment if necessary.

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. Funduscopic examination is recommended at the initiation and periodically during the course of Increlex therapy.

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