SUVEZEN 10 MG/10 MG FILM-COATED TABLETS [SIN16660P]

Product Info

SUVEZEN 10 MG/10 MG FILM-COATED TABLETS

[SIN16660P]

4.1 THERAPEUTIC INDICATIONS

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 patient.

• 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

4.2 DOSAGE AND METHOD OF ADMINISTRATION

Dosage
The patient should be on an appropriate lipid-lowering diet and should continue on this 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.

Co-administration with bile acid sequestrants
Dosing of Suvezen should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

Paediatric population
The safety and efficacy of Suvezen in children below the age of 18 years have not yet been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Elderly
A start dose of 5 mg rosuvastatin is recommended in patients >65 years (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The combination is not suitable for initial therapy. 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.

Hepatic impairment
No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Suvezen is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score>9) liver dysfunction. Suvezen is contraindicated in patients with active liver disease.

Renal impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment.
For patients with severe renal impairment the use of rosuvastatin is contraindicated.
The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min).

The 40 mg/10 mg dose is contraindicated in patients with moderate renal impairment. The use of Suvezen in patients with severe renal impairment is contraindicated for all doses

Race
Increased systemic exposure of rosuvastatin has been seen in Asian subjects. The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose. Suvezen 40 mg/10 mg film-coated tablets are contraindicated in these patients (see sections 4.3 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The physician who elects to use rosuvastatin at doses higher than 20 mg should periodically re-evaluate the long-term risk/benefit of rosuvastatin for the individual patient.

Genetic polymorphisms
Genotypes of SLCO1B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1B1 c.521TT and ABCG2 c.421CC. For patients known to have the c.521CC or c.421AA genotype, a maximum once daily dose of 20 mg of rosuvastatin is recommended.

Dosage in patients with pre-disposing factors to myopathy
The recommended start dose is rosuvastatin 5 mg in patients with pre-disposing factors to myopathy. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.
Suvezen 40 mg/10 mg film-coated tablets are contraindicated in some of these patients

Concomitant therapy
Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Suvezen is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir.
Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Suvezen therapy. In situations where co-administration of these medicinal products with Suvezen is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered.

Method of administration
Route of administration is oral. Suvezen can be administered at any time of the day, with or without food. The tablet should be swallowed whole with a drink of water.

4.3 CONTRAINDICATIONS

• Hypersensitivity to the active substances or to any of the excipients.

• Pregnancy, breast-feeding and in women of childbearing potential not using appropriate contraceptive measures.

• Active liver disease or unexplained persistent elevations in serum transaminases and any serum transaminase elevation exceeding 3x the upper limit of normal (ULN).

• In patients with severe renal impairment (creatinine clearance <30 ml/min).

• In patients with myopathy.

• In patients receiving concomitant ciclosporin.

The 40 mg / 10 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis. Such factors include:

• Moderate renal impairment (creatinine clearance <60 ml/min).

• Hypothyroidism.

• Personal or family history of hereditary muscular disorders.

• Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate.

• Alcohol abuse.

• Situations where an increase in plasma levels of rosuvastatin may occur.

• Asian patients.

• Concomitant use of fibrates.

(see sections 4.4, 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)