Suvezen® (Rosuvastatin / Ezetimibe)

Suvezen^®

Rosuvastatin / Ezetimibe

Profile

Suvezen is an HMG-coA reductase inhibitor in combination with other lipid-modifying agents, rosuvastatin and ezetimibe.

Presentations:
Suvezen 10mg/10mg, 20mg/10mg and 40mg/10mg:
Each film-coated tablet contains 10mg; 20mg or 40mg of rosuvastatin (as rosuvastatin calcium) respectively, and 10mg ezetimibe.

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Indication¹

Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH)

Suvezen is indicated as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia in adult patients

who are not appropriately controlled with statin alone,
who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products.

Prevention of Cardiovascular Events

Suvezen is indicated as substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently, at the same dose level as in the fixed dose combination, but as separate products to reduce the risk of cardiovascular events in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS).

Clinical efficacy and tolerability

Clinical efficacy of adding ezetimibe to statin monotherapy has been demonstrated with no worsening of side effects following the addition of ezetimibe.²

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Safety and tolerability

Organ system	Adverse events and frequency
Blood and lymphatic system disorders	Rare: Thrombocytopenia^b Not known: Thrombocytopenia^e
Immune system disorders	Rare: Hypersensitivity reactions including angioedema^b Not known: Hypersensitivity (including rash, urticaria, anaphylaxis and angioedema)^e
Endocrine disorders	Common: Diabetes mellitus^a,b
Metabolism and nutrition disorders	Uncommon: Decreased appetite^c
Psychiatric disorders	Not known: Depression^b,e
Nervous system disorders	Common: Headache^b,d, dizziness^b Uncommon: Paraesthesia^d Very rare: Polyneuropathy^b, memory loss^b Not known: Peripheral neuropathy^b, sleep disturbances (including insomnia and nightmares)^b, dizziness^e; paraesthesia^e, myasthenia gravis^b
Eye disorders	Unknown: Ocular myasthenia^b
Vascular disorders	Uncommon: Hot flush^c, hypertension^c
Respiratory, thoracic and mediastinal disorders	Uncommon: Cough^c Not known: Dyspnoea^b,e, cough^b
Gastrointestinal disorders	Common: Constipation^b, nausea^b, abdominal pain^b,c, diarrhoea^c, flatulence^c Uncommon: Dyspepsia^c; gastro-oesophageal reflux disease^c; nausea^c, dry mouth^d; gastritis^d Rare: Pancreatitis^b Not known: Diarrhoea^b, pancreatitis^e; constipation^e
Hepatobiliary disorders	Rare: Increased hepatic transaminases^b Very rare: Jaundice^b, hepatitis^b Not known: Hepatitis^e, cholelithiasis^e, cholecystitis^e
Skin and subcutaneous tissue disorders	Uncommon: Pruritus^b,d, rash^b,d, urticaria^b,d Not known: Stevens Johnson syndrome^b, erythema multiforme^e, drug reaction with eosinophilia and systemic symptoms (DRESS)^b
Musculoskeletal and connective tissue disorders	Common: Myalgia^b,d Uncommon: Arthralgia^c, muscle spasms^c; neck pain^c, back pain^d; muscular weakness^d; pain in extremity^d Rare: Myopathy (including myositis)^b, rhabdomyolysis^b, lupus-like syndrome, muscle rupture Very rate: arthralgia^b Not known: Immune-mediated necrotising myopathy^b, tendon disorders, sometimes complicated by rupture^b, myalgia^e; myopathy/rhabdomyolysis^e
Renal and urinary disorders	Very rare: Haematuria^b
Reproductive system and breast disorders	Very rare: Gynaecomastia^b
Investigations	Common: ALT and/or AST increased^d Uncommon: ALT and/or AST increased^c; blood CPK increased; gamma-glutamyltransferase increased^c; liver function test abnormal^c
General disorders and administration site conditions	Common: Asthenia^b, fatigue^c Uncommon: Chest pain^c; pain^c; asthenia^d; oedema peripheral^d Not known: oedema^b; asthenia^e

Please refer to the full SmPC for the complete list.¹

Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).^a frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/l, BMI >30 kg/m², raised triglycerides, history of hypertension) for rosuvastatin.^b Adverse reaction profile for rosuvastatin based on data from clinical studies and extensive post-marketing experience.^c Ezetimibe in monotherapy. Adverse reactions were observed in patients treated with ezetimibe (n=2,396) and at a greater incidence than placebo (n=1,159).^d Ezetimibe coadministered with a statin. Adverse reactions were observed in patients with ezetimibe co-administered with a statin (n=11,308) and at a greater incidence than statin administered alone (n=9,361).^e Additional adverse reactions of ezetimibe, reported in postmarketing experience (with or without statin).

Flexibility of dose range to suit individual patient needs¹

To be taken once per day; at the same time; with or without meals; as part of a low-fat dietary regimen.

Mode of Action

Plasma cholesterol is derived from intestinal absorption and endogenous synthesis. Suvezen contains rosuvastatin and ezetimibe, two lipid-lowering compounds with complementary mechanisms of action. Suvezen reduces elevated total cholesterol (total-C), LDL C, apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL C), and increases high-density lipoprotein cholesterol (HDL C) through dual inhibition of cholesterol synthesis and absorption.^1,5

Suvezen^® contains ezetimibe and rosuvastatin, two lipid-lowering compounds with complementary mechanisms of action.

Rosuvastatin produces larger reductions in LDL-C than older statins⁴

Administration¹

The patient should be on and continue, an appropriate lipid-lowering diet, during treatment with Suvezen. Suvezen is not suitable for initial therapy.

When Suvezen is indicated for patients not controlled by statin alone, the dose of Suvezen should be individualized according to the target lipid levels and the patient's response.

When Suvezen is indicated for patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate product, treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.

Patient should use the strength corresponding to their previous treatment.

The recommended dose is one Suvezen tablet daily. To be administered at any time of the day, with or without food.

The tablet should be swallowed whole with a drink of water. If co-administered with bile acid sequestrant (BAS), administration of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a BAS.

Patient Profiles

Which of these patients could benefit from treatment with SUVEZEN?

Primary prevention with
medium intensity statin

High CV risk

46 years old
Diabetic, HbA₁꜀: 7.5%
Hypertension, SBP: 155 mmHg
LDL-C: 2.6 mmol/L
Previous statin-related muscle pain
Simvastatin 20 mg

Diabetic with hyperlipidaemia and hypertension

Secondary prevention with
high intensity statin

Very high CV risk

55 years old
MI 6 weeks ago
LDL-C: 3.3 mmol/L
Atorvastatin 80 mg at discharge

Recent ACS event

Very high CV risk

65 years old
Established ASCVD, first ACS 18 months ago
LDL-C: 2.1 mmol/L
CABG
Rosuvastatin 10 mg

Non-recent ACS event

ACS = acute coronary syndrome; CABG = coronary artery bypass graft; CV = cardiovascular; HbA1c = haemoglobin A1c; LDL-C = low-density lipoprotein cholesterol; MI = myocardial infarction; SBP = systolic blood pressure.

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

High CV risk

Diabetic with hyperlipidaemia and hypertension
LDL-C: 2.6 mmol/L

High CV risk

Markedly elevated single risk factors, in particular TC > 8 mmol/L (>310 mg/dL), LDL-C > 4.9 mmol/L (>190 mg/dL), or BP ≥ 180/110 mmHg
Patients with FH without other major risk factors
Patients with DM without target organ damage, with DM duration ≥ 10 years or another additional risk factor
Moderate CKD (eGFR 30-59 mL/min/1.73 m2)
Calculated SCORE ≥ 5% and < 10% for 10-year risk of fatal CVD

High CV risk⁶

LDL-C goal: < 1.8 mmol/L AND a ≥ 50% reduction from baseline

Next Steps...

Escalate treatment^1,6

Add Suvezen if not appropriately controlled with statin alone

Follow up

Response to therapy can be assessed 6-8 weeks from therapy initiation
LDL-C should be assessed whenever available, with a full lipid profile if possible

BP = blood pressure; CKD = chronic kidney disease; CV = cardiovascular; CVD = cardiovascular disease; DM = diabetes mellitus; eGFR = estimated glomerular filtration rate; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; FH = familial hypercholesterolaemia; LDL-C = low-density lipoprotein cholesterol; SCORE = systematic coronary risk estimation; TC = total cholesterol.

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

Very High CV risk

MI 6 weeks ago
LDL-C: 3.3 mmol/L
Atorvastatin 80 mg at discharge

Recent ACS event

Very High CV risk

Documented ASCVD, including previous ACS or other documented ASCVD (clinical/imaging)
DM with target organ damage, or ≥ 3 major risk factors, or early onset of T1DM of long duration (>20 years)
Severe CKD (eGFR < 30 mL/min/1.73 m2)
Caculated SCORE ≥ 10% for 10-year risk of fatal CVD
FH with ASCVD or with another major risk factor

Prior ACS event

=

Very high CV risk⁶

LDL-C goal: <1.4 mmol/L AND a ≥ 50% reduction from baseline

Next Steps...

Escalate treatment^1,4,6

Switch patient to Rosuvastatin if not at goal with maximum tolerated atorvastatin
Add ezetimibe if still not at goal with maximum tolerated statin

Follow up⁶

Follow up every 4-6 weeks when not at target
Substitute for Suvezen when the patient has stabilised on the monocomponents

ACS = acute coronary syndrome; ASCVD = atherosclerotic cardiovascular disease; CKD = chronic kidney disease; CV = cardiovascular; CVD = cardiovascular disease; DM = diabetes mellitus; eGFR = estimated glomerular filtration rate; EAS = European Atherosclerosis Society; ESC = European Society of Cardiology; FH = familial hypercholesterolaemia; LDL-C = low- density lipoprotein cholesterol; MI = myocardial infarction; PCSK9i = pro protein convertase subtilisin/kexin type 9 inhibitor; SCORE = systematic coronary risk estimation; T1DM = type 1 diabetes mellitus.

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

Very High CV risk

Established ASCVD, first ACS 18 months ago
LDL-C: 2.1 mmol/L
Rosuvastatin 10 mg, CABG

Non-recent ACS event

Very High CV risk

Documented ASCVD, including previous ACS or other documented ASCVD (clinical/imaging)
DM with target organ damage, or ≥ 3 major risk factors, or early onset of T1DM of long duration (>20 years)
Severe CKD (eGFR < 30 mL/min/1.73 m2)
Calculated SCORE ≥ 10% for 10-year risk of fatal CVD
FH with ASCVD or with another major risk factor

Prior ACS event

=

Very high CV risk⁶

LDL-C goal: <1.4 mmo/L AND a ≥ 50% reduction from baseline

Next Steps...

Escalate treatment⁶

Add ezetimibe if not at goal with maximum tolerated statins

Follow up⁶

Follow up every 4-6 weeks when not at target
Substitute for Suvezen when the patient has stabilised on the monocomponents

Summary

*LDL C: low density lipoprotein cholesterol;

Click to view Leaflet for Healthcare Professionals

Suvezen^TM Summary of Product Characteristics. Available from www.medicines.ie last accessed April 2024.
Ballantyne CM, et al. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol. 2007;99(5):673-80.
Krahenbuhl S, et al. Unmet needs in LDL-C lowering: when statins won’t do! Drugs. 2016;76(12):1175-90.
Jones PH et al. Effects of rosuvastatin versus atorvastatin, simvastatin and pravastatin on non-high-density lipoprotein cholesterol, apolipoproteins, and lipid ratios in patients with hypercholesterolemia: additional results from the STELLAR trial. Clin Ther. 2004;26 (9):1388-99.
Schiele JT, Quinzler R, Klimm HD et al. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013; 69:937-948.
Mach F, Bagent C, Catapano AL et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias; lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;111-188.
Bangalore S, et al. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007;120(8):713-9.

MAT-IE-2300173 (v3.0)
Date of Preparation: April 2024

Profile

Indication¹

Clinical efficacy and tolerability

Safety and tolerability

Flexibility of dose range to suit individual patient needs¹

Mode of Action

Administration¹

Patient Profiles

Primary prevention with
medium intensity statin

Secondary prevention with
high intensity statin

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

=

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

=

Summary

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Profile

Indication1

Clinical efficacy and tolerability

Safety and tolerability

Flexibility of dose range to suit individual patient needs1

Mode of Action

Administration1

Patient Profiles

Primary prevention withmedium intensity statin

Secondary prevention withhigh intensity statin

ESC/EAS guidelines: Which CV risk category is this patient in?6

ESC/EAS guidelines: Which CV risk category is this patient in?6

=

ESC/EAS guidelines: Which CV risk category is this patient in?6

=

Summary

References

Indication¹

Flexibility of dose range to suit individual patient needs¹

Administration¹

Primary prevention with
medium intensity statin

Secondary prevention with
high intensity statin

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶

ESC/EAS guidelines:
Which CV risk category is this patient in?⁶