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Iplex

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Iplex

Indications
Dosage
How Supplied

INDICATIONS

IPLEX (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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) treatment.

IPLEX (mecasermin rinfabate [rdna origin] injection) is not a substitute for GH treatment.

DOSAGE AND ADMINISTRATION

IPLEX (mecasermin rinfabate [rdna origin] injection) dosage and administration should be individualized for each patient. IPLEX (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) should not be administered if the patient cannot or will not eat or if they skip a meal. Subsequent doses of IPLEX (mecasermin rinfabate [rdna origin] injection) should not be increased to make up for a missed dose.

In order to establish tolerability to IPLEX (mecasermin rinfabate [rdna origin] injection) , 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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) .

Rotate sites for injection (thigh, abdomen, upper outer buttock, 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 (mecasermin rinfabate [rdna origin] injection) 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.

For use, remove a vial of IPLEX (mecasermin rinfabate [rdna origin] injection) from the freezer. Thaw the contents by warming the vial in your hand for approximately 2 minutes. When the vial is at room temperature, gently swirl the vial in a rotary motion to ensure content uniformity. DO NOT SHAKE. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. DO NOT inject the contents if the solution is cloudy or discolored; discard the vial. Use IPLEX (mecasermin rinfabate [rdna origin] injection) within 12 hours after the vial is removed from the freezer. After removing the dose of IPLEX (mecasermin rinfabate [rdna origin] injection) , discard the vial with any unused portion.

Storage Conditions

IPLEX (mecasermin rinfabate [rDNA origin] injection) is temperature sensitive and should remain frozen at -15. 5°C to -1. 5°C (4.1 °F to 29.3°F ) until time of use. IPLEX (mecasermin rinfabate [rdna origin] injection) can be stored in a home freezer for up to 3 months.

When a freezer is unavailable, a vial of IPLEX (mecasermin rinfabate [rdna origin] injection) (stored for up to 3 months in a home freezer) can be stored at refrigerator temperature for up to 5 days. Use IPLEX (mecasermin rinfabate [rdna origin] injection) within 2 hours after the vial is removed from the refrigerator.

HOW SUPPLIED

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

Box containing 35 vials

NDC- 16249-001-01

Single vial

NDC- 16249-001-02

IPLEX (mecasermin rinfabate [rDNA origin] injection) is temperature sensitive and must be transported and stored frozen.

Manufactured for: Insmed Incorporated, Glen Allen, Virginia 23058. www.insmed.com. Manufactured by: Insmed Therapeutic Proteins Boulder, Colorado 80301. Revision Date: September 19, 2006

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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