Recommended Dose

The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin. The dose is administered as a reconstituted solution [see Dosage and Administration (2.3)] in patients fasted for at least 8 hours.

Important Recommendations Before MACRILEN Use

•

Discontinue strong CYP3A4 inducers prior to MACRILEN use [see Warning and Precautions (5.2) and Drug Interactions (7.2)].

•

Discontinue growth hormone (GH) therapy at least one week before administering MACRILEN [see Drug Interactions (7.3)].

•

Avoid the use of MACRILEN with drugs known to affect pituitary GH secretion [see Drug Interactions (7.3)].

•

For patients with deficiencies in sex hormones, thyroid hormone and/or glucocorticoid, adequately replace each of the missing hormones before administering MACRILEN.

•

Ensure that the patient has fasted for at least 8 hours before MACRILEN use.

Directions for Preparation and Administration

Prepare and administer by a healthcare professional exactly as follows.

Prepare the MACRILEN solution:

a.

Weigh the patient in kilograms (i.e., kg).

b.

Determine the number of MACRILEN pouches needed to prepare the dose:

i. For a patient weighing up to 120 kg, use 1 pouch.

ii. For a patient weighing more than 120 kg, use 2 pouches.

c.

Use a glass or transparent plastic container with graduation in milliliters (i.e., mL) to dissolve the entire contents of the pouch(es) in the appropriate volume of water.

i. For 1 pouch dissolve in 120 mL of water (corresponds to 60 mg/120 mL).

ii. For 2 pouches dissolve in 240 mL of water (corresponds to 120 mg/240 mL).

d.

Stir the MACRILEN solution gently for about 2 to 3 minutes (a small amount of un-dissolved particles will remain). The solution will have a final concentration of 0.5 mg/mL.

e.

Use the MACRILEN solution within 30 minutes after preparation.

f.

Discard any unused MACRILEN solution.

Determine the volume of MACRILEN solution needed for the test:

g.

Determine the recommended dose to be administered by multiplying the patient weight in kilogram by 0.5 mg/kg.

For example, a 70 kg patient will need a 35 mg dose.

h.

Determine the volume of prepared MACRILEN solution to be administered by dividing the recommended dose by 0.5 mg/mL.

For example, a patient requiring a dose of 35 mg will need 70 mL of reconstituted MACRILEN solution.

i.

Use a syringe (without a needle) with graduations in mL to measure the exact volume of MACRILEN solution to be administered and transfer the required volume of MACRILEN solution into a drinking glass.

Administer the MACRILEN solution and perform the test:

j.

Have the patient being tested drink the entire volume of MACRILEN solution in the drinking glass (i.e., the dose) within 30 seconds.

k.

Observe the patient being tested per routine for the duration of the test.

l.

Draw venous blood samples for GH determination at 30 minutes, 45 minutes, 60 minutes and 90 minutes after administration of MACRILEN.

m.

Prepare serum samples and send to a laboratory for growth hormone determinations.

n.

o.

p.

q.

r.

s.

t.

u.

v.

Interpretation of MACRILEN Test Results

Clinical studies have established that a maximally stimulated serum GH level of less than 2.8 ng/mL (i.e., at the 30, 45, 60 and 90 minute timepoints) following MACRILEN administration confirms the presence of adult growth hormone deficiency.