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Information from Clinical Studies

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

Clinical Resources

Access resources and information to assist you and your practice regarding patients you treat with Increlex®.

Getting Patients Started

Initiate the Increlex® treatment process by completing the SMN and returning this form to PACESM.

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

For a 25 kg child starting at 0.04 mg/kg BID sc:

25 x 0.04 = 1.0 mg BID

10 mg/cc = .10 cc or 10 units*

After 1 week, increase to 0.08 mg/kg BID sc

25 x 0.08 = 2.0 mg BID

10 mg/cc = .20 cc or 20 units*

After 2 weeks, increase to full maintenance dose of 0.12 mg/kg BID sc

25 x 0.12 mg = 3.0 mg BID

10 mg/cc = 0.3 cc or 30 units*

Each vial contains 4cc (13+ full maintenance doses for this patient)

*Increlex is typically given with a U-100 syringe; .1cc=10 units

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.

†Eligible patients may receive up to 8 months of Increlex therapy at no cost if the following criteria are met: Patient has been diagnosed with severe Primary IGFD. Patient's prescriptions are not paid in part or full by any state-funded or federally-funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD or TriCare. Patient is not a resident of Massachusetts. Insurance coverage for Increlex is actively being pursued by the prescriber. The patient's insurance company has not yet communicated a final coverage decision. Ipsen reserves the right to deny free starter drug therapy to anyone deemed ineligible with the stated program criteria. Call PACE at 1-866-435-5677 for more details.

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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