INCRELEX SUMMARY
INCRELEX™ (mecasermin [rDNA origin] injection)
INCRELEX™ (mecasermin [rDNA origin] injection) is an aqueous solution for injection containing human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
INCRELEX™ (mecasermin [rDNA origin] injection) is indicated for the long-term 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:
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height standard deviation score ≤–3.0 and
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basal IGF-1 standard deviation score ≤–3.0 and
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normal or elevated growth hormone (GH).
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.
INCRELEX™ 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 INCRELEX™ treatment.
INCRELEX™ is not a substitute for GH treatment.
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NEWS HIGHLIGHTS
Published Studies Related to Increlex (Mecasermin Injection)
Mecasermin rinfabate: rhIGF-I/rhIGFBP-3 complex: iPLEX. [2008.03]
BACKGROUND: Mecasermin rinfabate (iPLEX), comprising rhIGF-I complexed to rhIGFBP-3, was developed in an attempt to prolong the half-life of IGF-I and potentially reduce side effects. It is administered as a once-daily subcutaneous injection. Treatment with rhIGF-I has been explored in a number of growth and endocrine disorders. OBJECTIVE: To review the published literature regarding the pharmacokinetics, safety profile and clinical efficacy of Mecasermin rinfabate... CONCLUSIONS: The biological effects of Mecasermin rinfabate are largely similar to those previously reported with rhIGF-I. There are little published data pertaining to pharmacokinetic properties in human subjects, and the side effect profile appears similar to that of rhIGF-I alone.
Mecasermin. [2008]
Mecasermin (recombinant human insulin-like growth factor-I [IGF-I]) is approved in the US for the long-term treatment of growth failure in children with severe primary IGF-I deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH, and in the EU for the long-term treatment of growth failure in children and adolescents with severe primary IGF-I deficiency...
Mecasermin rinfabate. [2007.03]
Mecasermin rinfabate, a complex of equimolar amounts of insulin-like growth factor (IGF)-I and its binding protein IGFBP-3, has been approved by the U.S. Food and Drug Administration for treatment of severe primary IGF deficiency or for patients with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone...
Mecasermin Tercica. [2006.04]
Tercica, under license from Genentech, has developed and launched mecasermin, recombinant human insulin-like growth factor-1 (rhIGF-1), for the treatment of growth failure in children with primary IGF deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH..
Clinical Trials Related to Increlex (Mecasermin Injection)
Long-Term Treatment With rhIGF-1 in GHIS [Active, not recruiting]
Long term study of the effects of dosing with rhIGF-1 on growth
European Increlex® (Mecasermin [rDNA Origin] Injection) Growth Forum Database - IGFD Registry [Recruiting]
The purpose of this study is to collect long-term safety information on the use of
recombinant DNA-derived human Insulin Growth Factor-1 (rhIGF-I) Increlex® replacement
therapy for the treatment of children with growth failure.
rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency [Recruiting]
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in
response to another hormone called growth hormone. Growth Hormone is produced by a small
gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors
to growth during infancy, childhood, and adolescence.
Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone
and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but
IGF-1 levels do not increase normally in response to growth hormone. As a result, they have
a type of growth hormone insensitivity and an inability to grow normally.
This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will
help children with IGFD grow taller more quickly than children treated with rhGH alone. The
study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration
(FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH
in children with IGF-1 deficiency (IGFD) is investigational.
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency [Active, not recruiting]
This study is intended to assess the effects of once daily dosing of recombinant human
insulin-like growth factor (rhIGF-1) in increasing height velocity.
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex [Recruiting]
This project is a retrospective (beginning January 2006) and prospective patient registry
program sponsored by Tercica, Inc. In collaboration with participating health care
practitioners, the patient registry program is an observational study monitoring the
long-term safety of patients treated with Increlex™ (mecasermin [rDNA origin] injection).
The IGFD (Increlex® Growth Forum Database) Registry is intended primarily to monitor the
safety and efficacy of Increlex replacement therapy in children with growth failure.
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