Torvalipin Tablet 20 mg

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**4.2 Posology and method of administration** For oral administration. The patient should be placed on a standard cholesterol-lowering diet before receiving Torvalipin and should continue on this diet during treatment with Torvalipin. Doses should be determined individually according to the baseline LDL-cholesterol value, treatment objective and patient response. The usual starting dose is 10 mg once a day. Adjustment of dosage should be made at intervals of 4 weeks or more. The maximum dose is 80 mg once a day. The daily dose should be administered all at once and can be taken at any time of the day, with or without food. Dose of atorvastatin should not exceed 20 mg/day with concomitant use with elbasvir/grazoprevir. Current consensus guidelines should be consulted to establish treatment goals for individual patients. _Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia_ An appropriate dose for most patients is 10 mg Torvalipin a day. A response is evident within 2 weeks and maximum response is usually achieved within 4 weeks. The response is maintained during long term treatment. _Heterozygous familial hypercholesterolaemia_ Initial dose is 10 mg Torvalipin a day. Doses should be determined for each patient and adjusted at 4 week intervals up to 40 mg a day. Then the dose can be increased to either a maximum of 80 mg a day or administer 40 mg of atorvastatin once a day in combination with a bile acid sequestrant. _Homozygous familial hypercholesterolaemia_ In a compassionate-use study of patients with homozygous familial Hypercholesterolaemia, most patients responded to 80 mg of atorvastatin with a greater than 15% reduction in LDL-C (18% – 45%). _Prevention of cardiovascular disease_ In the primary prevention trials the dose was 10 mg/day. Higher dosages may be necessary in order to attain LDL-cholesterol levels according to current guidelines. _Patients with impaired renal function_ Renal diseases neither affect plasma concentration nor the effects of atorvastatin on blood lipids and therefore no dose adjustment is required. _Patients with impaired liver function_ Torvalipin should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Torvalipin is contraindicated in patients with active liver disease (see section 4.3). _Elderly_ Efficacy and safety of the use of recommended doses for patients over 70 years old are similar as for other adults. _Paediatric use_ Experience in paediatric population is limited to a small number of patients with homozygous familial hypercholesterolemia (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Developmental safety data in this population have not been evaluated.