IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) is indicated for the 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 and

· basal IGF-1 standard deviation score £ -3 and

· normal or elevated growth hormone

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.

IPLEX^Ã? 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 IPLEX^Ã? treatment.

IPLEX^Ã? is not a substitute for GH treatment.

IPLEX^Ã? dosage and administration should be individualized for each patient. IPLEX^Ã?should be administered via subcutaneous injection at an initial dose of 0.5 mg/kg, to be increased into the therapeutic dose range of 1 to 2 mg/kg, given once daily. IPLEX^Ã? can be given in the morning or in the evening but should be administered at approximately the same time every day and the patient should maintain a regular, balanced diet. IPLEX^Ã? should not be administered if the patient cannot or will not eat or if they skip a meal. Subsequent doses of IPLEX^Ã? should not be increased to make up for a missed dose.

In order to establish tolerability toIPLEX^Ã?, glucose monitoring should be considered at treatment initiation or when a dose has been increased. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. Glucose monitoring is also advised for patients with recent occurrences of asymptomatic or symptomatic hypoglycemia. If evidence of hypoglycemia is present at the time of dosing, the dose should be withheld.

Dosage can be titrated up to a maximum of 2 mg/kg daily based on measurement of IGF-1 levels obtained 8-18 hours after the previous dose. Treating physicians should target on-treatment IGF-1 levels of 0 to +2 SD score for age. Dosage should be adjusted downward in the event of adverse effects (including hypoglycemia) and/or IGF-1 levels that are greater than or equal to 3 standard deviations above the normal reference range for IGF-1.

Growth response to IPLEX^Ã? is expected to decrease with time, as seen with other growth-promoting agents. However, failure to increase height velocity during the first year of therapy by at least 2 cm/year suggests the need for assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under-nutrition, and advanced bone age. Patients with undetectable ALS levels at baseline may require higher doses of IPLEX^Ã?.

Rotate sites for injection (thigh, abdomen, buttocks, or upper arm). New injections should be given at least one inch from previous injection site(s) and never into areas where the skin is tender, bruised, red, hard, or lipodystrophic.

IPLEX^Ã? 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.

Remove IPLEX^Ã? from the freezer and thaw at room temperature for approximately 45 minutes. After thawing, allow vial to reach room temperature prior to injection (approximately 45 minutes). The vial should be swirled in a gentle rotary motion to ensure content uniformity. DO NOT SHAKE. If the solution is cloudy, it may indicate that the drug was previously thawed or exposed to extreme temperatures. If so, it MUST NOT be injected. Discard any vial that contains particulate matter, is cloudy or discolored. Use within one hour after the vial reaches room temperature. IPLEX^Ã? MUST NOT be injected if it has been exposed to room temperature for more than two hours. After removing the dose of IPLEX^Ã?, discard the vial with any unused portion.

IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) is temperature sensitive and must be stored frozen at -70°C (-94°F) while in the distribution chain. The patient must be instructed to keep the medication frozen while transferring it to his/her home freezer (-20°C, -4°F). Frozen (-70° C) IPLEX^Ã? from the distributor can be transported on dry ice to the patients home freezer. The medication must remain in the patients home freezer until time of use. Do not store in a home freezer that allows contents to thaw during the defrost cycle. Do not use medication if it thaws during transfer or storage, as stability of material may be affected. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is cloudy it may indicate that the drug was previously thawed or exposed to extreme temperatures. If so, it MUST NOT be injected. Discard any vial that contains particulate matter, is cloudy or discolored.

IPLEX^Ã?can be stored frozen up to two months at constant temperature (-20°C, -4°F). For use, IPLEX^Ã? should be removed from the freezer (-20°C, -4°F) and thawed at room temperature (20-25°C, 68-77°F) for 45 minutes prior to use. After thawing, allow vial to reach room temperature prior to injection (approximately 45 minutes). The vial should be swirled in a gentle rotary motion to ensure content uniformity. DO NOT SHAKE. Use within one hour after the vial reaches room temperature. IPLEX^Ã? MUST NOT be used if it has been at room temperature for more than two hours. After removing the dose of IPLEX^Ã?, discard the vial with any unused portion.

IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) is supplied as a 36 mg/0.6 mL preservative-free sterile solution in single dose glass vials.. Each box contains 35 vials.

IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) is temperature sensitive and must be stored frozen at -70°C (-94°F) while in the distribution chain. The patient must be instructed to keep the medication frozen while transferring it to his/her home freezer (-20°C, -4°F).

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