Iplex

Iplex - General Information

Iplex contains recombinant-DNA-engineered human insulin-like growth factor-1 (rhIGF-1). IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.

Pharmacology of Iplex

Iplex is designed to replace natural IGF-1 in pediatric patients who are deficient, promoting normalized statural growth. Patients with severe primary IGF-1 deficiency (Primary IGFD) fail to produce adequate levels of IGF-1, due to disruption of the growth hormone (GH) pathway used to promote IGF-1 release (possible GH pathway disruptions include mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects).

Iplex for patients

Patients and/or their parents should be instructed in the safe administration o f INCRELEX. INCRELEX should be given shortly before or after (20 minutes on either side of) a meal or snack. INCRELEX should not be administered when the meal or snack is omitted. The dose of INCRELEX should never be increased to make up for one or more omitted doses. INCRELEX therapy should be initiated at a low dose and the dose should be increased only if no hypoglycemia episodes have occurred after at least 7 days of dosing. If severe hypoglycemia or persistent hypoglycemia occurs on treatment despite adequate food intake, INCRELEX dose reduction should be considered. Providers should educate patients and caregivers on how to recognize the signs and symptoms of hypoglycemia.

Patients and/or parents 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.

Iplex Interactions

Iplex Contraindications

INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops.

Intravenous administration of INCRELEX is contraindicated.

INCRELEX should not be used by patients who are allergic to mecasermin (IGF-1) or any of the inactive ingredients in INCRELEX.

Additional information about Iplex

Iplex Indication: For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH. It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes; it is not a substitute for GH therapy.
Mechanism Of Action: Iplex supplies recombinant-DNA-origin IGF-1, which binds to the Type I IGF-1 receptor. This receptor exerts intra-cellular signaling activity in a number of processes involved in statural growth, including mitogenesis in multiple tissue types, chondrocyte growth and division along cartilage growth plates, and increases in organ growth.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Mecasermin
Synonyms: Mecasermin rinfabate
Drug Category: Not Available
Drug Type: Biotech; Approved; Investigational

Other Brand Names containing Mecasermin: Increlex (Tercica); Iplex;
Absorption: While the bioavailability of rhIGF-1 after subcutaneous administration in healthy subjects has been reported to be close to 100%, the absolute bioavailability of mecasermin given subcutaneously to subjects with primary insulin-like growth factor-1 deficiency (Primary IGFD) has not been determined.
Toxicity (Overdose): There is no clinical experience with overdosage of mecasermin. Based on known pharmacological effects, acute overdosage would be predicted to lead to hypoglycemia. Long-term overdosage may result in signs and symptoms of acromegaly.
Protein Binding: In blood, IGF-1 is bound to six IGF binding proteins, with > 80% bound as a complex with IGFBP-3 and an acid-labile subunit.
Biotransformation: Both the liver and the kidney have been shown to metabolize IGF-1.
Half Life: 2 hours
Dosage Forms of Iplex: Solution Subcutaneous
Chemical IUPAC Name: Not Available
Chemical Formula: C331H518N94O101S7
Mecasermin on Wikipedia: Not Available
Organisms Affected: Humans and other mammals