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Information from Clinical Studies

Five clinical studies were conducted in children with severe Primary IGFD.

Safety Profile

The safety profile of Increlex® has been extensively evaluated in long-term clinical trials.

Dosing Increlex®

For information on what dosage may be appropriate for your patient

Increlex Is the Only FDA-Approved Treatment for Severe Primary IGFD

Increased understanding of the role of IGF-1 in short stature and severe Primary IGFD has led to long-term clinical trials and proven effectiveness of the only FDA-approved therapy for the treatment of severe Primary IGFD, as defined by1:

  • Height standard deviation score ≤ -3.0 and
  • Basal IGF-1 standard deviation score ≤ -3.0 and
  • Normal or elevated growth hormone (GH)

Consider Increlex when the above criteria are met and the secondary causes of IGFD have been excluded. Increlex is also approved for patients with GH gene deletion who have developed neutralizing antibodies to GH.1

Patient Reevaluation

Response to treatment 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.

Simply plot your patient's weight and stature and follow the line to obtain your patient's growth percentile and standard deviation score (SDS).

If a child is tracking below the average this can be an idication that the child needs to be evalutated and perhaps reevaluated to determine a specific diagnosis.

If your patients are already on GH therapy but not responding, consider reevaluating those previously diagnosed with ISS, GH insensitivity, and GH failure to determine if they meet the criteria for severe Primary IGFD:

  • Idiopathic Short Stature
  • Growth Hormone Insensitivity

When the diagnosis is severe Primary IGFD, replace what’s missing with Increlex®.

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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