IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) is supplied as a single use, preservative-free solution for subcutaneous injection. Aseptic technique must be followed for administration. Discard any unused portion.

If sensitivity to IPLEX^Ã? occurs, treatment should be discontinued.

Therapy with IPLEX^Ã? (mecasermin rinfabate [rDNA origin] injection) should be directed by physicians experienced in the diagnosis and management of patients with growth disorders.

IPLEX^Ã? has not been studied in children less than 3 years of age or adults with Primary IGFD.

IPLEX^Ã? should be administered at approximately the same time every day. Because it has insulin-like hypoglycemic effects, patients should avoid missing meals and should have a balanced diet. IPLEX^Ã? should not be administered on days when the patient cannot or will not eat. Special attention should be paid to small children because their oral intake may be inconsistent. At the time of initiation of IPLEX^Ã? therapy and any upward adjustment of dose patients should avoid engaging in any high-risk activities until tolerability has been established (e.g., 3 - 5 days).

Lymphoid tissue hypertrophy (e.g., tonsillar and adenoidal) has been associated with IPLEX^Ã?. Patients should have periodic examinations to detect potential complications of adenotonsillar enlargement (such as excessive snoring, sleep apnea, chronic middle ear effusions, hearing loss) and receive appropriate treatment if necessary.

The syndrome of intracranial hypertension, with papilledema, visual changes, headache, and nausea and/or vomiting, may occur during treatment with IPLEX^Ã? and has been reported in children with growth failure treated with related products (growth hormone, rhIGF-1). Fundoscopic examination is recommended at the initiation of and periodically during the course of IPLEX^Ã? therapy.

Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth. These conditions and other symptoms and signs known to be associated with GH treatment in general should be monitored during IPLEX^Ã? treatment.

As with any exogenous protein administration, local or systemic allergic reactions may occur. Parents and patients should be informed that such reactions are possible and that if an allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought.

Patients and/or their caregivers should be instructed in the safe administration of IPLEX^Ã?. Because of the possibility of hypoglycemia, patients using IPLEX^Ã? should be on a regular, balanced diet. IPLEX^Ã? should be administered at the same time every day. IPLEX^Ã? should not be administered if the patient cannot or will not eat or when a meal is omitted. Therapy should be instituted in accordance with the prescribing physicians instructions. The dose of IPLEX^Ã? should not be increased to make up for a missed dose. If severe or persistent hypoglycemia occurs on treatment despite adequate food intake, IPLEX^Ã? dose reduction should be considered. Providers should educate patients and caregivers on how to recognize the signs and symptoms of adverse reactions, particularly hypoglycemia.

Patients and/or caregivers should be thoroughly instructed in the importance of proper needle disposal. A puncture-resistant container should be used for the disposal of used needles and/or syringes (consistent with applicable state requirements). Needles and syringes must not be reused.

Long-term animal studies for the evaluation of carcinogenicity with mecasermin rinfabate (rhIGF-1/rhIGFBP-3) have not been performed.

The genotoxic potential of mecasermin rinfabate has not been assessed. rhIGF-1 tested negative for genotoxic potential in the Ames test and in chromosomal aberration assays conducted with human lymphocytes or rat peripheral lymphocytes.

Animal fertility studies have not been performed with mecasermin rinfabate. Effects of rhIGF-1 on fertility and reproductive performance were assessed in male and female rats administered 0.4, 2, and 10 mg/kg/day subcutaneously (0.2, 1, and 7 times clinical exposures with the maximum recommended human dose [MRHD] based on body surface area). rhIGF-1 had no effects on mating, fertility, or reproductive performance in rats.

Animal reproduction studies have not been conducted with mecasermin rinfabate. Effects of rhIGF-1 on embryofetal development were assessed in rats and rabbits.

Subcutaneous administration of 0.4, 2, or 10 mg/kg/day rhIGF-1 to pregnant rats during organogenesis had no effects on embryofetal development (0.5, 1.5, and 4 times therapeutic exposures with MRHD based on body surface area).

Subcutaneous administration of 0.2, 0.5, or 1.25 mg/kg/day rhIGF-1 to rabbits during organogenesis resulted in an increased incidence of fetal loss but no fetal anomalies. Increased early resorptions were observed in rabbits treated with 1.25 mg/kg and increased preimplantation loss was observed (exposure equivalent to ≥0.3 times MRHD based on body surface area).

A second rabbit embryofetal development study was conducted to determine the role of hypoglycemia in rhIGF-1 mediated fetal loss. Rabbits were administered subcutaneous doses of 0, 0.5, and 1.25 mg/kg/day rhIGF-1; 1.25 or 2.5 mg/kg rhIGF-1 plus glucose supplementation; or 2.5 IU/kg/day insulin. A comparable degree of hypoglycemia was observed in rabbits treated with 1.25 mg/kg rhIGF-1 alone or 2.5 IU/kg insulin. Animals treated with 0.5 mg/kg rhIGF-1 or rhIGF-1 plus glucose maintained normal glucose levels.

Similar to the initial rabbit study, an increase in early fetal resorptions was observed in rabbits treated with 1.25 mg/kg/day rhIGF-1 (2 times MRHD based on body surface area). This finding was not observed in insulin-treated rabbits despite a comparable degree of drug-induced hypoglycemia. A dose-related increase in postimplantation loss was observed in all rhIGF-1 treated groups (≥0.5 times MRHD based on body surface area). While the incidence of fetal loss was somewhat reduced in glucose-supplemented rabbits, it was not clearly attributable to drug-induced hypoglycemia since significant fetal loss was still observed in normoglycemic rhIGF-1 treated rabbits.

The effects of IPLEX^Ã? on an unborn child have not been studied. Therefore, there is insufficient medical information to determine whether there are significant risks to a fetus.

It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when IPLEX^Ã? is administered to a nursing woman.

The safety and effectiveness of IPLEX^Ã? in patients aged 65 and over has not been established.

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