Regulatory Information
ORGANON SINGAPORE PTE. LTD.
ORGANON SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**V. DOSAGE AND ADMINISTRATION** The patient should be placed on a standard cholesterol-lowering diet before receiving VYTORIN and should continue on this diet during treatment with VYTORIN. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient’s response. VYTORIN 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 VYTORIN, 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 VYTORIN should be restricted to patients who have been taking VYTORIN 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity (see VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ – _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 VYTORIN 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 above, VI. CONTRAINDICATIONS, and VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). VYTORIN 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 VYTORIN, the dose of VYTORIN should not exceed 10/40 mg/day (see VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _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 VYTORIN is 10/20 mg once a day in the evening. In such patients, the use of higher doses should be closely monitored (see VII. PRECAUTIONS, _IVb-5. Characteristics in Patients (Special Populations)_ and _IVc. CLINICAL STUDIES_ – _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 _IVb-5. Characteristics in Patients (Special Populations)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Use in Pediatric Patients**_ Treatment with VYTORIN 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 VYTORIN is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction (see VII. PRECAUTIONS and _IVb-5. Characteristics in Patients (Special Populations)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Coadministration with other medicines**_ Dosing of VYTORIN 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 VYTORIN, the dose of VYTORIN should not exceed 10/20 mg/day (see VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients taking amlodipine concomitantly with VYTORIN, the dose of VYTORIN should not exceed 10/40 mg/day (see VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and effectiveness of VYTORIN administered with fibrates have not been studied. Therefore, the combination of VYTORIN and fibrates should be avoided (see VI. CONTRAINDICATIONS, VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**III. INDICATIONS** _**Primary Hypercholesterolemia**_ VYTORIN 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)_** VYTORIN 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.
**VI. 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 VIII. PREGNANCY and IX. NURSING MOTHERS – _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 VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _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 VII. PRECAUTIONS, _Myopathy/Rhabdomyolysis_ and XI. DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Manufacturer Information
ORGANON SINGAPORE PTE. LTD.
MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)
PT Organon Pharma Indonesia Tbk (Primary and Secondary Packager)