Agamree Dosage

Assessments Prior to First Dose of AGAMREE

Administer all immunizations according to immunization guidelines prior to starting AGAMREE. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting AGAMREE [see Warnings and Precautions (5.8)].

Dosing Information

The recommended dosage of AGAMREE is 6 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 300 mg for patients weighing more than 50 kg.

Some patients may respond to a dose of 2 mg/kg daily. Doses may be titrated down to 2 mg/kg/day as needed, based on individual tolerability.

Recommended Dosage for Hepatic Impairment

The recommended dosage of AGAMREE in patients with mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment is 2 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 100 mg for patients weighing more than 50 kg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Doses may be titrated down based on individual tolerability.

Important Preparation and Administration Instructions

Shake AGAMREE oral suspension well for about 30 seconds before administration.

Use only the oral syringe provided with the product. After withdrawing the appropriate dose into the oral syringe, dispense directly into the mouth.

Discard any unused AGAMREE oral suspension remaining after 3 months of first opening the bottle.

Switching from Corticosteroid Treatment to AGAMREE

Patients can be switched from oral corticosteroid treatment (such as prednisone or deflazacort) to AGAMREE without treatment interruption or period of prior corticosteroid dosage reduction to minimize the risk for adrenal insufficiency.

Patients switching after long-term treatment with oral corticosteroids should start AGAMREE at a dosage of 6 mg/kg/day.

Dosage Modification for Use with Strong CYP3A4 Inhibitors

The recommended dosage of AGAMREE when administered with strong CYP3A4 inhibitors is 4 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 200 mg for patients weighing more than 50 kg [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Doses may be titrated down based on individual tolerability.

Discontinuation

Dosage of AGAMREE must be decreased gradually if the drug has been administered for more than one week [see Warnings and Precautions (5.1)].