Posology : מינונים

4.2    Posology and method of administration
The use of MACRILEN must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency.

Posology

Adult population
The dose is calculated based on the patient´s body weight. The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.

Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin. These substances could lead to unreliable GH stimulation results (see also section 4.4 and 4.5).

Renal and/or hepatic impairment
The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2). No data are available.
If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded. It is unknown whether this may affect QTc. Therefore, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin (see also section 4.4). Based on current understanding, this potential is unlikely to decrease the specificity of the test.

Elderly
Growth hormone secretion normally decreases with age. The efficacy of macimorelin in patients aged over 65 years has not been established. In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable. In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point.

Paediatric population
The safety and efficacy of macimorelin in children and adolescents below 18 years have not yet been established (see also section 5.2). No data are available.

Method of administration
Oral use
MACRILEN granules are to be reconstituted with water and must be used within 30 minutes after preparation. Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.
The number of test sachets needed is based on body weight. One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg. The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.

Assessment of fasted condition and lack of prior strenuous physical exercise Before using MACRILEN it is important to ensure that the patient is in fasting condition for at least 8 hours and did not have strenuous physical exercises 24 hours before the test, since both could affect GH levels. If either of these conditions is not met, the growth hormone stimulation test must be re-scheduled for a new test day.
During the test, the patient needs to stay fasted until the end of the blood sampling. Fluid intake of no more than 100 mL of non-carbonated water is allowed each within 1 hour pre-dose, as well as within 1 hour post-dose (see section 4.4).

Long-term use

Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.