Optimal Dosing for Optimal Growth

Dosing Increlex^®

Dose vs growth rate data for patients in clinical trials (n=71), comparing a subset (n=27) who received an average dose between 0.10 and 0.12 mg/kg BID to a subset (n=15) who received an average dose between 0.06 and 0.10 mg/kg BID for the first 2 years of treatment.

There is a clear relationship between Increlex dose and height velocity.¹ Data from a subset (n=27) of the 71 patients in the clinical trials who received an average dose between .10-.12 mg/kg BID for the first two years of treatment grew more than children on lower doses.³⁴ On average, height velocity of children treated with higher doses tripled over baseline in the first year.³⁴ In year 2, the height velocity of these patients remained at more than twice baseline levels. On average, patients receiving higher doses grew an added 14.8 cm (5.8) inches above pretreatment over the 2 years.³⁴

Individualize the Dose

The dosage of Increlex should be individualized for each patient with the recommended starting dose of 0.04 to 0.08 mg/kg given twice daily by subcutaneous (sc) injection.¹ If this is well-tolerated for at least 1 week, the dose may be increased by 0.04 mg/kg dose to the maximum dose of 0.12 mg/kg given twice daily.¹ Doses greater than 0.12 mg/kg BID have not been evaluated in children with severe Primary IGFD and should not be used.¹

For complete dosing and administration information, please see the package insert

Dosing Example¹⁰

Administration with Food

Increlex should be administered shortly before or after (± 20 minutes) a meal or snack. If the patient is unable to eat shortly before or after a dose for any reason, that dose of Increlex should be withheld. Subsequent doses of Increlex should never be increased to make up for one or more omitted dose.¹

Label and Packaging

Increlex is supplied as a 10mg/ml sterile solution in a 40 mg (4cc) multi-dose glass vial.¹

Starter kits of Increlex are supplied to qualified patients containing a gel pack, educational brochure, PACE brochure, Increlex instructions, travel calendar, needle clipper, medical waste bag for used needles, alcohol swabs, band-Aids, and a 30-day supply of syringes.

*Patients must be diagnosed with severe Primary IGF-1 Deficiency. Patients covered in part or in full by Medicare, Medicaid, or other state or federally funded programs, and Massachusetts residents, are not eligible for these programs. Void where prohibited by law, taxed, or restricted. Contact PACE at 866.435.5677 for more details regarding eligibility.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For Patient Product Information, click here.
For Full Prescribing Information, click here.