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Increlex (Mecasermin Injection) - Summary

 
 



INCRELEX SUMMARY

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:

  • height standard deviation score ≤–3.0 and

  • basal IGF-1 standard deviation score ≤–3.0 and

  • 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..

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Clinical Trials Related to Increlex (Mecasermin Injection)

IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex [Terminated]
This project is a retrospective (beginning January 2006) and prospective patient registry program sponsored by Ipsen (formerly 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.

rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency [Completed]
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.

Effect of Increlex� on Children With Crohn Disease [Terminated]
Patients with Crohn disease often have poor weight gain and short stature, yet the etiology of the poor growth is not well defined. Studies in chronically ill patients who do not have Crohn disease have suggested that inflammation causes IGF-1 deficiency due to inadequate IGF-1 generation. Previous studies of GH use in Crohn patients have demonstrated improvement in linear growth, weight and bone mineralization. However, GH can cause glucose intolerance in chronically ill children, particularly those who require treatment with corticosteroids. Recently the FDA has approved recombinant IGF-1 (rhIGF) for treatment of IGF-1 deficient short stature. This medication has not been studied in Crohn disease. The purpose of this study is to test the hypothesis that poor growth in Crohn disease is associated abnormal IGF-1 generation which leads to poor linear growth, decreased weight and osteoporosis and that replacement of IGF-1 with rhIGF will correct growth and improve bone density. To test our hypothesis we will recruit 20 patients with Crohn disease from our pediatric gastroenterology practice. Each will have been previously diagnosed with Crohn disease for a minimum of one year and will be studied at baseline and six month intervals for one year while on treatment with Increlex.

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-like Growth Factor-1 (rhIGF-I) Increlex® replacement therapy for the treatment of children with growth failure.

Long-Term Treatment With rhIGF-1 in GHIS [Active, not recruiting]
Long term study of the effects of dosing with rhIGF-1 on growth

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Reports of Suspected Increlex (Mecasermin Injection) Side Effects

Convulsion (10)Headache (8)Vomiting (8)Anaemia (7)Hepatic Cirrhosis (6)Condition Aggravated (6)Alopecia (6)Nasopharyngitis (5)Pyrexia (5)Toxoplasmosis (5)more >>


Page last updated: 2008-11-03

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