Simvaxon 10, 20, 40, 80 mg

/ Dexcel Pharma Technologies Ltd

Coronary Heart Disease: can be started simultaneously with diet. The usual starting dose is 10 to 20 mg/day given as a single dose in the evening. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day. Hypercholesterolemia: the patient should be placed on a standard cholesterol-lowering diet, and should continue on this diet during treatment. The usual starting dose is 10-20 mg/day given as a single dose in the evening. Patients who require a large reduction in LDL-C (more than 45 %) may be started at 20-40 mg/day given as a single dose in the evening. Adjustments of dosage, if required, should be made at intervals of not less than 4 weeks up to a maximum of 80 mg/day. Homozygous familial hypercholesterolemia: the recommended dosage is 40 mg/day in the evening. Should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. Simvastatin exposure is approximately doubled with concomitant use of lomitapide, therefore the dose of Simvastatin should be reduced by 50% if initiating lomitapide. Simvastatin dosage should not exceed 20mg/day (or 40mg/day for patients who have previously taken Simvastatin 80mg/day chronically, e.g. for 12 months or more, without evidence of muscle toxicity) while taking lomitapide. Restricted Dosing for 80 mg: due to increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of 80mg dose should be restricted to patients who have been taking simvastatin 80mg chronically (e.g. for 12 months or more) without evidence of muscle toxicity. Patients who are currently tolerating the 80mg dose who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction. Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80mg dose, patients unable to achieve their LDL-C goal utilizing the 40mg dose should not be titrated to the 80mg dose, but should be placed on alternative LDL-C lowering treatment that provides greater LDL-C lowering. Concomitant therapy/ renal insufficiency /Chinese patients: for additional information, please contact the license holder.

In patients with coronary heart disease and hypercholesterolemia: reduce the risk of total mortality by reducing coronary death; reduce the risk of non-fatal myocardial infarction; reduce the risk for undergoing myocardial revascularization procedures; reduce the risk of stroke and TIA’s. Hyperlipidemia: As adjunct to diet to reduce elevated TOTAL-C LDL-C Apo B and TG; to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb), therefore lowers the LDL-C/HDL-C, and the total- C/HDL-C ratios. Homozygous familial hypercholesterolemia: as adjunct to diet and other non-dietary measures in reducing elevated total cholesterol, LDL-cholesterol, apo-lipoprotein B in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. Hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Indicated for treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
Simvaxon 80mg is also indicated in patients at a high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease: to reduce the risk of total mortality by reducing CHD deaths; reduce the risk of non-fatal myocardial infarction and stroke; reduce the need for coronary and non-coronary revascularization procedures.

Pregnancy, may become pregnant, lactation, hypersensitivity  to active substance/excipients, liver problems/ active liver disease/unexplained persistent elevations of serum transaminases, co- administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors (e.g. nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone), co-administration of  gemfibrozil, cyclosporin, or danazol. In patients with HoFH, concomitant administration of lomitapide with doses >40mg Simvaxon.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.

For additional information, please contact the license holder.