Atova® is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Atova® is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in patients estimated to have a high risk for a first or subsequent cardiovascular event, as an adjunct to correction of other risk factors.
Dosage and Administration
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualized according to baseline LDL-C levels, the goal of therapy and patient response, using current consensus guidelines. Atova® may be given at any time of day, with or without food.
Usual Adult Dose
Primary hypercholesterolemia and Combined (mixed) hyperlipidemia:
Usual dose 10 mg daily; increased if necessary up to 80 mg daily, dose to be increased at intervals of at least 4 weeks.
Heterozygous familial hypercholesterolemia and Homozygous familial hypercholestrolemia:
Initially 10 mg daily for at least 4 weeks, then increased if necessary to 40 mg daily for at least a further 4 weeks, then increased if necessary up to 80 mg daily.
- Primary prevention of cardiovascular events in patients at high risk of a first cardiovascular event:20 mg daily, dose can be increased if necessary.
- Secondary prevention of cardiovascular events: 80 mg once daily.
- Pediatric Use
Heterozygous familial hypercholesterolemia
Child 10–18 years: Initially 10mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20mg once daily.
Homozygous familial hypercholesterolemia
Child 10–18 years: Initially 10mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80mg once daily.
Child less than 10 years: Not indicated.
- Use in the elderly:Patients >70 years: No dose adjustment necessary.
In chronic kidney disease, for primary and secondary prevention of cardiovascular events, initially 20 mg once daily, increased if necessary (on specialist advice if eGFR < 30 mL/minute/1.73 m2 ); max. 80 mg once daily.
Atova® should be used with caution in patients with hepatic impairment. Atova® is contraindicated in patients with active liver disease.