VASITIMB TABLETS 10MG/10MG [SIN17038P]

Product Info

VASITIMB TABLETS 10MG/10MG

[SIN17038P]

4.1 Therapeutic indications

Primary Hypercholesterolemia
Vasitimb is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)
Vasitimb is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

4.2 Posology and method of administration

Posology

The patient should be placed on a standard cholesterol-lowering diet before receiving Vasitimb and should continue on this diet during treatment with Vasitimb. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. Vasitimb should be taken as a single daily dose in the evening, with or without food.

The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is 10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After initiation or titration of Vasitimb, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed. Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10/80-mg dose of ezetimibe/simvastatin should be restricted to patients who have been taking ezetimibe/simvastatin 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage in Patients with Homozygous Familial Hypercholesterolemia
The recommended dosage for patients with homozygous familial hypercholesterolemia is ezetimibe/simvastatin 10/40 mg/day or 10/80 mg/day in the evening. The 10/80 mg dose is only recommended when the benefits are expected to outweigh the potential risks (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Vasitimb should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
In patients taking lomitapide concomitantly with ezetimibe/simvastatin, the dose of ezetimibe/simvastatin should not exceed 10/40 mg/day (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with Renal Impairment
In patients with mild renal insufficiency (estimated GFR ≥60 mL/min/1.73 m²) no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73 m², the dose of ezetimibe/simvastatin is 10/20 mg once a day in the evening. In such patients, the use of higher doses should be closely monitored (see sections 4.4, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in the Elderly
No dosage adjustment is required for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Pediatric Patients
Treatment with Vasitimb is not recommended.

Use in Hepatic Impairment
No dosage adjustment is required in patients with mild hepatic insufficiency (Child-Pugh score 5 or 6). Treatment with Vasitimb is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Coadministration with other medicines
Dosing of Vasitimb should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

In patients taking amiodarone, verapamil, diltiazem, or products containing elbasvir or grazoprevir concomitantly with ezetimibe/simvastatin, the dose of ezetimibe/simvastatin should not exceed 10/20 mg/day (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients taking amlodipine or ticagrelor concomitantly with ezetimibe/simvastatin, the dose of ezetimibe/simvastatin should not exceed 10/40 mg/day (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The safety and effectiveness of ezetimibe/simvastatin administered with fibrates have not been studied. Therefore, the combination of ezetimibe/simvastatin and fibrates should be avoided (see sections 4.3, 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients.

• Active liver disease or unexplained persistent elevations of serum transaminases.

• Pregnancy and nursing (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of potent CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, erythromycin, boceprevir, telaprevir, clarithromycin, telithromycin, nefazodone, and drugs containing cobicistat) (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Concomitant administration of gemfibrozil, cyclosporine, or danazol (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).