Ipsen Increlex 10mg is used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called severe primary IGF-1 deficiency. Increlex® should not be used for other causes of growth failure and should not be used instead of growth hormone.
Ipsen Increlex 10mg is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (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).
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 antiinflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex treatment. Increlex is not a substitute to GH for approved GH indications. Increlex® has not been studied in children 2 years of age.
Posology and method of administration
Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.
The dose should be individualised for each patient. The recommended starting dose of mecasermin is 0.04 mg/kg of body weight twice daily by subcutaneous injection. If no significant adverse reactions occur for at least one week, the dose may be raised in increments of 0.04 mg/kg to the maximum dose of 0.12 mg/kg given twice daily. Doses greater than 0.12 mg/kg twice daily should not be exceeded as this may increase the risk of neoplasia (see section 4.3, 4.4 and 4.8).
If the recommended dose is not tolerated by the patient, treatment with a lower dose can be considered. Treatment success should be evaluated based on height velocities. The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
The safety and efficacy of mecasermin in children below age of 2 have not been established. No data are available.
Therefore, this medicinal product is not recommended in children below age of 2.
There are limited data concerning the pharmacokinetics of mecasermin in children with hepatic impairment, in this specific population of severe primary IGFD patients. It is recommended that the dose be individualised for each patient as described under posology
There are limited data concerning the pharmacokinetics of mecasermin in children with renal impairment, in this specific population of severe primary IGFD patients. It is recommended that the dose be individualised for each patient as described under posology
Method of administration
INCRELEX should be administered by subcutaneous injection shortly before or after a meal or snack. If hypoglycaemia occurs with recommended doses, despite adequate food intake, the dose should be reduced. If the patient is unable to eat, for any reason, this medicinal product should be withheld. The dose of mecasermin should never be increased to make up for one or more omitted doses.
Injection sites should be rotated to a different site with each injection.
INCRELEX should not be administered intravenously.
Precaution to be taken before manipulating or administering the medicinal product
The solution should be clear immediately after removal from the refrigerator. If the solution is cloudy, or contains particulate matter, it must not be injected.
INCRELEX should be administered using sterile disposable syringes and injection needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy. http://konozahealthbiotech.com
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