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Iplex developed by Sequenom is indicated for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Iplex is for subcutaneous injection only and is a preservative-free, clear, sterile, colorless-to-slightly-yellow liquid.
Therapy with Iplex should be directed by physicians experienced in the diagnosis and treatment of patients with augmentation disorders. It is contraindicated in patients with closed epiphyses, active or suspected neoplasia, or a reaction to Iplex. Because of insulin-like hypoglycemic effects, Iplex should be administered at about the same time each day, and patients should avoid missing meals and eat a balanced diet. Tonsillar and adenoid hypertrophy was reported in clinical trials and patients should have periodic examinations to detect potential complications of adenotonsillar enlargement. Headache was reported in 8 out of 36 children in a clinical trial. Papilledema was reported in a clinical trial, including one case with increased intracranial pressure, which resolved with revision of a blocked existing ventriculoperitoneal shunt.
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Iplex is an aqueous solution for injection containing a binary protein complex of human insulin like growth factor-1 (rhIGF-1) and human insulin like growth factor binding protein-3 (rhIGFBP-3), both produced by recombinant DNA technology. The amino acid sequence of the rhIGF-1 protein is same to that of endogenous human IGF-1. The amino acid sequence of the rhIGFBP-3 protein is same to that of endogenous human IGFBP-3, which consists of 264 amino acid residues with a molecular weight of 28,732 daltons. The amino acid sequence of the rhIGFBP-3 protein is same to that of endogenous human IGFBP-3.
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