Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Severe Primary IGFD is defined by:
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. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
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 (see section 5.1). 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
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.
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.
Acute overdose could lead to hypoglycaemia. Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects. Oral glucose or food should be consumed. If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycaemic effects.
Long-term overdose may result in signs and symptoms of acromegaly or gigantism. Overdosing may lead to supraphysiological IGF-1 levels and may increase the risk of benign and malignant neoplasm.
In case of an acute or a chronic overdose, Increlex must be discontinued immediately. If Increlex is restarted, the dose should not exceed the recommended daily dosage (see section 4.2).
Shelf life: 3 years.
After opening: Chemical and physical in-use stability has been demonstrated for 30 days at 2°C to 8°C. From a microbiological point of view, once opened, the medicinal product may be stored for a maximum of 30 days at 2°C to 8°C.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after first opening of the medicinal product, see section 6.3.
5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic).
Each vial contains 4 ml of solution.
Pack size of 1 vial.
INCRELEX is supplied as a multi-dose solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
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