LIVALO FILM-COATED TABLETS 2MG [SIN15859P]

Product Info

LIVALO FILM-COATED TABLETS 2MG

[SIN15859P]

4.1 Therapeutic indications
Patients with primary hyperlipidemia including familial hypercholesterolaemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo-B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) and children aged 10 years and older with familial hypercholesterolemia when response to diet and other non-pharmacological measures are inadequate.
Since there is no experience of use in homozygous cases of familial hypercholesterolemia, administration of LIVALO should be considered as a treatment supplementary to non-drug therapy such as LDL-apheresis and only when treatment with LIVALO is judged indispensable.

4.2 Posology and method of administration
For oral use only and should be swallowed whole tablet, or half tablet of 2mg if requiring 1mg of pitavastatin calcium. If halving of tablets is necessary, the tablets should only be halved when a dose is required. LIVALO can be taken at any time of the day with or without food. It is desirable that the patient takes the tablet at the same time each day. Statin therapy is generally more effective in the evening due to the circadian rhythm of lipid metabolism. Patients should be on a cholesterol lowering diet before treatment. It is important that patients continue dietary control during treatment.

Adults: Starting dose is 2mg of pitavastatin calcium orally once daily. The dosage may be adjusted according to the patient’s age and symptoms. When lowering of the LDL-C level is insufficient, the dosage may be increased to a maximum of 4mg per day. Adjustment of dose should be made at intervals of 4 weeks or more.

Special populations
Elderly: No dosage adjustment is required (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population: The usual dosage for children aged 10 years and older is 1mg of pitavastatin calcium orally once daily. The dosage may be adjusted according to the patient’s symptoms. When lowering of the LDL-C level is insufficient, the dosage may be increased to a maximum of 2mg per day. Adjustment of dose should be made at intervals of 4 weeks or more. Safety of pitavastatin calcium in low birth weight infants, newborns, infants, and children under 10 years of age has not been established (pitavastatin calcium has not been used in children under 10 years of age in Japan and has not been used in children under 6 years of age in Europe).
Use of LIVALO should be considered only for those who are considered appropriate to receive LIVALO under the supervision of adequately trained and experienced physicians for the treatment of paediatric familial hypercholesterolemia. When LIVALO is used in children, attention should be given to the frequency or intensity of exercise and creatine kinase (CK) level elevation, and LIVALO should be administered with caution (Since the frequency and intensity of exercise tends to be higher in children, myopathy is more likely to develop in this population).
Patients with impaired renal function: 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 1 mg once daily and maximum dose of 2 mg once daily.
Patients with impaired hepatic function: LIVALO is contraindicated in patients with active liver disease which may include unexplained persistent elevations of hepatic transaminase levels (see sections 4.3).

4.3 Contraindications
LIVALO is contraindicated:

• in patients with known hypersensitivity to pitavastatin or to any of the excipients

• in patients with active liver disease or unexplained persistent elevations in serum transaminases

• in patients with myopathy

• in patients receiving concomitant ciclosporin

• during pregnancy, while breastfeeding and in women of child bearing potential not taking appropriate contraceptive precautions