Suvezen® (Rosuvastatin / Ezetimibe)

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

Not known: 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 rare: 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/or post-marketing experience 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).

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.

Please consult the SMPC for more information, this is available upon request.

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).