TORVALIPIN TABLET 20 MG [SIN14175P]

Product Info

TORVALIPIN TABLET 20 MG

[SIN14175P]

4.1 Therapeutic indications
Hypercholesterolaemia
Torvalipin is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, or triglycerides in patients with primary hypercholesterolaemia including heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia (such as Frederickson’s types IIa and IIb), when satisfactory results have not been obtained by a special diet or measures other than medication.
Torvalipin is also indicated to reduce total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Prevention of Cardiovascular Disease
Torvalipin is indicated to reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age ≥ 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminia or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol ≥ 6, or premature family history of coronary heart disease.

In patients with type 2 diabetes and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking or hypertension, Torvalipin is indicated to:

• Reduce the risk of myocardial infarction

• Reduce the risk of stroke

In patients with clinically evident coronary heart disease, atorvastatin is indicated to:

• Reduce the risk of non-fatal myocardial infarction

• Reduce the risk of fatal and non-fatal stroke

• Reduce the risk of revascularization procedures

• Reduce the risk of hospitalization for CHF

• Reduce the risk of angina

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.

4.3 Contraindications
Torvalipin is contraindicated in:

• Patients with a history of hypersensitivity to the active substance or to any of the excipients.

• Patients with an active liver disease or unexplained persistent elevation of serum transaminase levels where the elevation is exceeding three times the mean upper limits.

• Patients with myopathy.

• Pregnant and breast feeding women and women of child bearing potential not using contraceptives (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients who are concomitantly treated with glecaprevir/pibrentasvir.