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.

Preprandial glucose monitoring should be considered at treatment initiation and until a well tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. The dosage of INCRELEX should be individualized for each patient. The recommended starting dose of INCRELEX is 0.04 to 0.08 mg/kg (40 to 80 µg/kg) twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily. Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with Primary IGFD and, due to potential hypoglycemic effects, should not be used. If hypoglycemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. 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.

INCRELEX injection sites should be rotated to a different site with each injection.

INCRELEX should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

STABILITY AND STORAGE

Before Opening - Vials of INCRELEX are stable when refrigerated [2º to 8ºC (35º to 46ºF)]. Avoid freezing the vials of INCRELEX. Protect from direct light. Expiration dates are stated on the labels.

After Opening Vials of INCRELEX are stable for 30 days after initial vial entry when stored at 2º to 8ºC (35º to 46ºF). Avoid freezing the vials of INCRELEX. Protect from direct light.

Vial contents should be clear without particulate matter. If the solution is cloudy or contains particulate matter, the contents must not be injected. INCRELEX should not be used after its expiration date. Keep refrigerated and use within 30 days of initial vial entry. Remaining unused material should be discarded.

INCRELEX is supplied as a 10 mg/mL sterile solution in multiple dose glass vials (40 mg/vial).

NDC-15054-1040-5

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