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)
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 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.
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.
Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection) [Recruiting]
The investigators are recruiting children for a research study using a medication known as
IGF-1 (mecasermin or INCRELEX) to see if it improves the health of children with Rett
syndrome (RTT). To participate in the study your child must be female, between the ages of 2
to 12 and have a genetic diagnosis (MECP2 deletion or mutation) of Rett Syndrome. As you may
know, there is no treatment for this illness. Currently, the standard management of Rett
syndrome is supportive, which means attempting to prevent complications and treatment of
symptoms.
This study involves testing an investigational drug, which means that even though IGF-1 is
approved by the Food and Drug Administration (FDA) for use in children, it has not been used
before to treat Rett syndrome specifically. Information from this research will help
determine whether the drug should be approved by the FDA in the future for the treatment of
Rett Syndrome.
There are three goals to this study:
1. As one of the features of Rett Syndrome is unstable vital signs, the investigators are
trying to determine if IGF-1 has any effect on normalizing your child's pulse, blood
pressure and breathing pattern. During PHASE 2, a device called BioRadio® will be used
to monitor vital signs in a non-invasive way. This information will be recorded and
stored on the accompanying laptop. Before starting PHASE 2, the investigators would
like to "beta-test" the BioRadio® in PHASE 1. As such, the investigators may ask you to
try using the BioRadio® with your child to test the fit and the performance of the
equipment. Should you choose to enroll your child in PHASE 2, the investigators will
then ask that your child wear the BioRadio® for two hours, on two consecutive days
every four weeks.
2. The safety of IGF-1 in children with Rett syndrome. The study personnel will ask you to
complete a medication diary and side effect reporting form on a regular basis. They
will assist you in completing this by telephone interviews. Your child will undergo 2
lumbar punctures performed at the bedside in the clinical research facility. In
addition, laboratory tests will be performed throughout the study to evaluate the
safety of IGF-1. These will be blood tests similar to those provided in routine
clinical care. Your child will undergo regular non-invasive comprehensive physical
examinations including neurological and eye examination, tonsil evaluation,
electrocardiograms (ECG), measurement of height, weight and head circumference.
3. IGF-1 may improve your child's behavior, communication and speech. In order to measure
this, the investigators will evaluate your child once during each month of treatment
with neurodevelopmental assessments and a neurological exam. All of the tests used
during these evaluations are non-invasive. the investigators will also ask you what
your impressions are about her behavior and day-to-day activities through a structured
parental interview and various questionnaires.
Effect of Increlex� on Children With Crohn Disease [Recruiting]
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.
Long-Term Treatment With rhIGF-1 in GHIS [Active, not recruiting]
Long term study of the effects of dosing with rhIGF-1 on growth
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 >>
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Page last updated: 2008-11-03
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