Posology : מינונים

4.2   Posology and method of administration

INCR-SPC-1222-V1                              Page 1 of 13
Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders.

Posology
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).
Paediatric population
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 indicated in children below age of 2.

Special Populations
Hepatic impairment
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.

Renal impairment
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.