Ezomib Dosage/Direction for Use

The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezomib.
Route of administration is oral. The recommended dose is one Ezomib 10 mg tablet daily. Ezomib can be administered at any time of the day, with or without food.
When Ezomib is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.
Use in Patients with Coronary Heart Disease: Combination Therapy with a Statin: For incremental cardiovascular event reduction in patients with coronary heart disease, Ezomib 10 mg may be administered with a statin with proven cardiovascular benefit.
Use in Patients with Renal Impairment/Chronic Kidney disease: Monotherapy: No dosage adjustment is required for renally impaired patients (see PHARMACOLOGY: Pharmacokinetics under Actions).
Combination therapy with Simvastatin: In patients with mild renal impairment (estimated GFR ≥ 60 ml/min/1.73 m²), no dosage adjustment of Ezomib or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate < 60 rnL/min/1.73 m², the dose of Ezomib is 10 mg and the dose of simvastatin is 20 mg once day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored.
Co-administration with bile acid sequestrants: Dosing of Ezomib should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.
Use in the elderly: No dosage adjustment is required for elderly patients (see PHARMACOLOGY: Pharmacokinetics under Actions).
Paediatric population: Initiation of treatment must be performed under review of a specialist.
Adolescents ≥ 10 years (pertubal status: boys Tanner Stage II and above and girls who are at least one year post-menarche): No dosage adjustment is required (see PHARMACOLOGY: Pharmacokinetics under Actions). The clinical experience in paediatric and adolescent patients (aged 10 to 17 years old) is however limited.
When Ezomib is administered with simvastatin, the dosage instructions for simvastatin, in adolescents should be consulted.
Children < 10 years: Ezomib is not recommended for use in children below age 10 due to insufficient data on safety and efficacy (see PHARMACOLOGY: Pharmacokinetics under Actions).
Use in hepatic impairment: No dosage adjustment is required in patients with mild hepatic insufficiency (Child Pugh score 5 to 6).
Treatment with Ezomib is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction. (See Precautions and PHARMACOLOGY: Pharmacokinetics under Actions.)