LIVAZEBE FILM-COATED TABLETS 4 MG/10 MG [SIN17395P]

Product Info

LIVAZEBE FILM-COATED TABLETS 4 MG/10 MG

[SIN17395P]

Indication

4.1 Therapeutic indications

Hypercholesterolemia/Familial Hypercholesterolemia
LIVAZEBE is indicated as adjunct therapy to diet for treatment of primary hypercholesterolaemia including heterozygous familial.
LIVAZEBE is indicated as adjunct therapy to LDL apheresis for treatment of homozygous familial hypercholesterolaemia or when such therapies are not feasible.

Dosing

4.2 Posology and method of administration

Posology
LIVAZEBE should be used in patients where use of a fixed-dose combination is appropriate

• patients not appropriately controlled with a statin alone

• patients already treated with a statin and ezetimibe

Patients should be on an appropriate lipid lowering diet and continue on this diet during treatment with LIVAZEBE.

In general for adult patients, 1 tablet of LIVAZEBE can be orally administered once daily at any time of the day, with or without food.

A liver function test should be performed when switching from statin monotherapy to LIVAZEBE. In addition, it is recommended that liver function tests be performed before the initiation of LIVAZEBE and if signs or symptoms of liver injury occur. (See sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) During treatment with LIVAZEBE, blood lipid levels should be examined periodically. If no response to the treatment is observed, the treatment should be discontinued.

If hyperlipidaemia is present due to complications with hypothyroidism, obstructive gall bladder/biliary tract diseases, chronic renal failure, pancreatitis, or secondary factor such as taking drugs which adversely affect serum lipid, etc., LIVAZEBE should be administered after treatment of the primary disease or switching of drugs is performed as thoroughly as possible.

Rhabdomyolysis
Since adverse events related to rhabdomyolysis may occur as the dose of pitavastatin (systemic exposure) increases, caution should be exercised to prodromal symptoms of rhabdomyolysis, such as increased CK levels, myoglobinuria, myalgia and feelings of weakness, when the dosage is increased to 4 mg of pitavastatin calcium. (See sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Special population
Paediatrics
No clinical studies have been conducted to evaluate efficacy and safety in paediatric patients.

Elderly
If adverse reactions occur, measures such as dose reduction should be taken. Physiological function is generally decreased. (See section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Hepatic disorder
LIVAZEBE is contraindicated in patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels. (See section 4.3)
It is recommended not to administer LIVAZEBE to patients with moderate or severe hepatic impairment. When LIVAZEBE is used in patients with liver disorders, periodical clinical monitoring is recommended because each monotherapy of active ingredients shown the influence on plasma concentration of the active ingredients. (See section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Renal impairment
Moderate and severe renal impairment (glomerular filtration rate. 30 – 59 and 15 – 29 mL/min/1.73 m², respectively) as well as end-stage renal disease receiving hemodialysis: Starting dose of pitavastatin 1 mg once daily and maximum dose of pitavastatin 2 mg once daily. LIVAZEBE 2 mg/10 mg is not suitable for initial therapy. LIVAZEBE 4 mg/10 mg should not be used in patients with moderate and severe renal impairment.
When LIVAZEBE is used in patients with renal impairments, periodical clinical monitoring is recommended because each monotherapy of active ingredients shown the influence on plasma concentration of the active ingredients. (See section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Contraindications

4.3 Contraindications

• Patients with a history of hypersensitivity to any of the components of LIVAZEBE.

• Patients with active liver disease or unexplained persistent elevations in serum transaminase orbiliary obstruction. (See sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Patients with myopathy. (See section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Patients receiving cyclosporine. (See section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Women who are or may be pregnant, breast-feeding women and women of childbearing potential not taking appropriate contraceptive precautions. (See section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)